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pdfAttachment 4
Project Protocol
Enhanced STD Surveillance Network
(SSuN)
Revision Request
OMB# 0920-1072
March 2020
17 December 2019
STD Surveillance Network (SSuN)
Project Protocol
&
Implementation Guide
SSuN Cycle 4
(2019 – 2024)
Version 12.2 Date: December 2019
SSuN Cycle 4 (Version 12.2)
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17 December 2019
Table of Contents
Page Number
Primary CDC Collaborators
Associate CDC Collaborators
Non CDC Collaborators
iii
iii
iv
Background
Supported Jurisdictions (2019-2024)
1
3
Section 1: SSuN Cycle 4 Protocol Sections
4
A.
B.
C.
D.
E.
F.
G.
H.
Overarching Responsibilities/Activities of Collaborators
CDC Responsibilities/Activities
Uses of SSuN Data
SSuN Memorandum of Agreement
SSuN Strategy A – STD Clinic-Based Sentinel Surveillance
SSuN Strategy B – Enhanced Case-based Surveillance
SSuN Strategy C – STD Surveillance Focus Activities
Data Management
Section 2: Appendices
1. Memorandum of Agreement
2. Data Use Proposal Template
3. Data Collection Templates
4. SSuN Data Dictionaries
a. Strategy A - STD Clinic Visit Dataset
b. Strategy A - STD Clinic Diagnosis Dataset
c. Strategy A - STD Clinic Laboratory Dataset
d. Strategy A - STD Clinic Treatment Dataset
e. Strategy A - STD Clinic Facility Reference Dataset
f. Strategy B - STD Case Dataset
g. Strategy B - STD Treatment Dataset
h. Strategy B – Patient Interview Dataset
i. Strategy B - STD Laboratory Observation Dataset
j. Strategy B - Provider Reference Dataset
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10
11
16
17
24
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38
39
39
43
45
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73
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87
90
92
95
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120
140
144
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Collaborators (CDC)
Mark Stenger, MA
STD Surveillance Network, Lead Science Officer
Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Marvin Fleming
STD Surveillance Network, Project Officer
Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Associate Collaborators (CDC):
Cassandra Davis
Program Development and Quality Improvement Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Brian Raphael, PhD
Lead, Gonorrhea, Chlamydia, and M. genitalium Team
Laboratory Reference and Research Branch
Division of STD Prevention (NCHHSTP)
Centers for Disease Control and Prevention
Atlanta, GA
Eloisa Llata, MD, MPH
STD Surveillance Network, Science Officer
Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Tremeka Sanders
STD Surveillance Network, Project Coordinator
Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
LaZetta Grier
STD Surveillance Network, Data Manager
Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Elizabeth Torrone, PhD, MSPH
Team Lead, Surveillance and Special Studies Team
Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, GA 30333
Hillard S. Weinstock, MD, MPH
Chief, Surveillance & Data Management Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
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Non-CDC Collaborators, SSuN Cycle 4 (2019 – 2024)
Baltimore City Health Department
Columbus, OH 43215
Adena H. Greenbaum, MD, MPH
Baltimore City Health Department
Bureau of HIV/STD Services
1001 East Fayette Street
Baltimore, MD 21202
Audrey Regan
Director, Sexual Health Promotion
Columbus Public Health
240 Parsons Ave.
Columbus, OH 43215
Christina Schumacher, PhD.
Johns Hopkins School of Medicine
Bayview Medical Center
5200 Eastern Avenue
MFL Building, Center Tower, Suite 4200
Baltimore, MD 21224
California Department of Public Health
James Watt, MD, MPH
California Department of Public Health
Division of Communicable Disease Control
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Florida Department of Health
Angela Peralta
Epidemiologist
STD & Viral Hepatitis Prevention and Control Section
4025 Esplanade Way
Tallahassee, FL 32399
Craig Wilson
STD & Viral Hepatitis Prevention and Control Section
Florida Department of Health
4052 Bald Cyprus Way, Bin A-19
Tallahassee, FL 32399
Indiana State Department of Health
Ryan Murphy, PhD.
California Department of Public Health
STD Control Branch
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Caitlin Conrad
Director, STD Prevention
2 N. Meridian St.
Indianapolis, IN 46204
Multnomah County Health Department
Emily Han, MPH
California Department of Public Health
STD Control Branch
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Kim Toevs, MPH
Multnomah County Health Department
Adolescent Health Promotion & STD/HIV/HCV
Programs
426 SW Stark, 6th Floor
Portland, OR 97204
Nicole Olsen Burghardt, MPH
California Department of Public Health
STD Control Branch
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Jaime Walters, MPH
Multnomah County Health Department
Community Epidemiology Services
426 SW Stark Street, 3rd Floor
Portland, OR 97204
City of Columbus/Columbus Public Health
New York City Dept. of Health and Mental Hygiene
Denisse Licon McClure, PhD, MPH
Epidemiology Supervisor
Columbus Public Health
240 Parsons Ave.
Preeti Pathela, DrPH, MPH
NYC Department of Health & Mental Hygiene
Bureau of STD Control and Prevention
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42-09 28th Street
Queens, NY 11101
Ellen Klingler, MPH
NYC Department of Health & Mental Hygiene
Bureau of STD Control and Prevention
42-09 28th Street
Queens, NY 11101
Philadelphia Department of Public Health
Steve Alles, MD
Philadelphia Department of Public Health
Division of Disease Control
500 South Broad Street
Philadelphia, PA 19146
San Francisco Department of Public Health
Applied Research, Community Health Epidemiology,
and Surveillance Branch
Population Health Division
356 7th Street
San Francisco, CA 94103
Robert Kohn, MPH
San Francisco Department of Public Health
Applied Research, Community Health Epidemiology,
and Surveillance Branch
Population Health Division
356 7th Street
San Francisco, CA 94103
Utah Department of Health
Lenore Asbel, MD
Philadelphia Department of Public Health
Division of Disease Control
500 South Broad Street
Philadelphia, PA 19146
Scott White, MS, MPH
Epidemiology Manager
Utah Department of Health
288 North 1460 West, PO Box 142104
Salt Lake City, UT 84114
Robbie Madera, MPH
Philadelphia Department of Public Health
Division of Disease Control
500 South Broad Street
Philadelphia, PA 19146
Washington State Department of Health
San Francisco Dept. of Public Health
Susan Philip, MD, MPH [SSuN PI]
San Francisco Department of Public Health
Division of STD Control
1360 Mission Street, Suite 401
San Francisco, CA 94103
Trang Nguyen, PhD, MPH
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Rachel Amiya, PhD
Washington State Department of Health
Infectious Disease Assessment Unit
Disease Control and Health Statistics
P.O. Box 47838
Olympia, WA 98504
Roxanne Kerani, PhD
Center for AIDS and STD
University of Washington
Harborview Medical Center, Box 359931
325 9th Avenue
Seattle, WA 98104
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Introduction - Background
The STD Surveillance Network (SSuN) was established in 2005 to create a robust network of
geographically diverse collaborating health departments with the capacity to implement a wide
variety of enhanced STD surveillance activities, the flexibility to modify activities over time as
trends and emergent issues demand, and the ability to use surveillance data in a timely way to
inform STD prevention policy at all levels of the public health infrastructure to guide STD
programmatic action.
SSuN was expanded in 2008 to include more collaborating health departments and further
strengthen the human resources, data management and IT infrastructure capacity. Activities
funded in 2008 included monitoring the prevalence of STDs, HIV, viral hepatitis, and risk
behaviors in MSM, assessing trends in the burden of genital wart disease in patients attending
STD clinics, monitoring HIV testing coverage in patients attending STD clinics, and implementing
population-based enhanced gonorrhea surveillance to provide estimates of demographic and
behavioral characteristics of diagnosed and reported cases.
In 2013, ten sites were funded to maintain the network’s core focus on sentinel surveillance in
STD clinics, expanded these sentinel surveillance activities to include patients being seen in
reproductive health/family planning settings. Case-based enhanced surveillance activities were
revised to include brief provider investigations to obtain important clinical and treatment
information, additional look-back data from health department records and added interview
questions related to care-seeking behaviors, HIV preventive services such as pre-exposure
prophylaxis (PrEP) and sexual network/partnership characteristics.
Revisions to data
management processes with respect to data quality assurance, and collection of fully relational
laboratory, provider, treatment and diagnoses datasets enhanced the utility of data across both
core surveillance components of SSuN in the 2013 – 2019 funding cycle. Additionally, weighting
algorithms were developed to assure timely weighted analysis of sampled cases and routine
dissemination of findings.
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The current cycle of SSuN (Cycle 4, 2019 - 2024) continues the network’s focus on enhanced STD
surveillance through three primary surveillance strategies. Strategy A continues sentinel
surveillance activities in STD specialty clinics serving populations at risk for HIV and STDs. Strategy
B supports enhanced, case-based surveillance among reported cases of STD (gonorrhea and
adult syphilis). Additional, shorter-term, STD surveillance activities constitute Strategy C; these
activities will vary throughout funding period and address emergent issues in STD incidence,
prevalence of co-infections , immediate complications of STDs and longer-term consequences of
STDs.
Collectively, these three strategies and corresponding activities constitute the core work of the
network. Emphasis is added in Cycle 4 on STD-related HIV prevention opportunities; HIV-registry
matching activities cross-cut Strategies A and B in Cycle 4 for reported cases and for patients
being seen in STD specialty clinics. This activity is central to identifying opportunities and gaps in
the HIV/STD prevention continuum and for strengthening programs, policies and research that
are guided by the principles of high impact prevention (HIP).
This protocol document describes methods that funded jurisdictions will use in implementing
these enhanced and sentinel surveillance strategies. Additional information on the STD
Surveillance Network may be obtained by contacting CDC SSuN Project staff:
Mark Stenger, Lead Science Officer
STD Surveillance Network
Surveillance and Special Studies Team
Surveillance and Data Management Branch
Division of STD Prevention, NCCHSTP, CDC
1600 Clifton Rd NE, MS US12-2
Atlanta, GA 30329 - 4027
email: [email protected]
Marvin Fleming, SSuN Project Officer
STD Surveillance Network
Surveillance and Special Studies Team
Surveillance and Data Management Branch
Division of STD Prevention, NCCHSTP, CDC
1600 Clifton Rd NE, MS US12-2
Atlanta, GA 30329 – 4027
email: [email protected]
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Supported Jurisdictions - SSuN Cycle 4
The following state, county and/or city health departments successfully competed for funding
under CDC-RFA-PS19-1907, STD Surveillance Network (SSuN).
Baltimore City Health Department
California Department of Public Health
Columbus Public Health/City of Columbus
Florida Department of Health
Indiana State Department of Health
New York City Department of Health and Mental Hygiene
Multnomah County Health Department
Philadelphia Department of Public Health
San Francisco Department of Public Health
Utah Department Health
Washington State Department of Health
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SSuN Cycle 4 Protocol Sections:
A. Overarching Responsibilities/Activities of Collaborators
1. Fidelity to data collection protocols
2. Adherence to data security and confidentiality requirements
3. Full participation in all SSuN meetings, conference calls and collaborations
4. Participation in project evaluation and data quality assurance processes
5. Provision of technical assistance (TA) to state and local STD programs
B.
C.
D.
E.
CDC Responsibilities/Activities
Data use guidelines
Memorandum of Agreement
Strategy A – Facility-Based Sentinel Surveillance
i. Methods
ii. HIV Registry Matching Requirements
F. Strategy B – Case-Based Surveillance:
i. Gonorrhea
ii. Adult (non-congenital) syphilis
iii. HIV Registry Matching Requirements
G. Strategy C – Surveillance Focus Activities:
i. Lymphogranuloma venereum surveillance
ii. Enhanced chlamydia surveillance
iii. Neuro, ocular and otic syphilis
iv. Syndromic surveillance for ocular, neuro or otic syphilis
v. Implementation of HL7 case reporting through NNDSS
vi. Targeted technical assistance to PCHD recipients
H. Data Management
I. Appendices
1. Memorandum of Understanding
2. Data Use Proposal Template
3. Sample Data Collection Templates
4. Data Dictionary
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A.
Overarching Responsibilities/Activities of Collaborators
i.
Fidelity to data collection protocols and methods
ii.
Adherence to data security and confidentiality requirements
iii.
Full participation in all SSuN meetings, conference calls and collaborations
iv.
Participation in project evaluation and data quality assurance processes
v.
Provision of technical assistance (TA) to state and local STD programs
SSuN cooperative agreement recipients are competitively chosen based on superior human
resources and local health department capacity for participation in the STD Surveillance Network.
SSuN jurisdictions are considered key collaborators in CDC’s efforts to maintain robust, flexible
and comprehensive capacity for STD surveillance in the United States. CDC expects that the
legacy of high performance in SSuN will continue to generate robust, high-impact surveillance
data and analytic products to inform our understanding of the epidemiology of STDs in the U.S.
and to guide efforts to prevent and control sexually transmitted infections and their
consequences.
Jurisdictions receiving funding under CDC-RFA-PS19-1907 are required to participate in the
implementation, maintenance and evaluation of sentinel and enhanced surveillance activities as
requirements of their cooperative agreement; continued funding is contingent on maintaining
outstanding levels of performance across all funded strategies and activities.
All SSuN collaborators are required to complete the project Memorandum of Agreement (MOA;
see section D and Appendix 1) governing shared expectations for recipient conduct, collaboration
and participation in analyses and dissemination of SSuN findings.
i.
Fidelity to data collection protocols and methods:
SSuN protocols and data collection methods have been developed over multiple cooperative
agreement cycles to maximize the efficiency and utility of these important surveillance activities
and to assure valid, reliable, timely and useful results. CDC expects that SSuN collaborators will
adhere to all protocols for data collection with regard to collecting required data elements, data
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collection methods, data cleaning and quality assurance, formatting and routine, secure
transport of data to CDC in a timely fashion according to agreed schedules.
CDC staff will work with funded collaborators to provide for reasonable local flexibility in
implementing specific activities, where necessary, to reflect local public health contexts and
conditions – while assuring comparability of data across all funded areas. SSuN Science Officers,
Project Officers and Subject Matter Experts (SMEs) will also work with collaborators to identify
and address relevant training and/or technical assistance needs to assure success of local
activities. All SSuN collaborators contribute de-identified record and case-level clinical, disease
surveillance, behavioral, laboratory and other public health-related observations to aggregate
national project datasets; the accuracy, validity and reliability of these data depend critically on
the comparability of methods across funded sites as well as a commitment on the part of SSuN
collaborators to due diligence in data collection, data cleaning and quality assurance.
ii.
Adherence to data security and confidentiality requirements:
SSuN-funded jurisdictions are public health departments, and from this perspective are not
considered covered entities under HIPAA regulation:
“Without individual authorization, a covered entity may disclose protected health information to a
public health authority that is legally authorized to collect or receive the information for the
purposes of preventing or controlling disease, injury, disability including, but not limited to
reporting of disease...and conducting public health surveillance…” (MMWR, 2003).
Yet SSuN values the principles embodied in these patient-level protections and strives to
establish and maintain the highest level of performance in protecting the confidentiality and
security of all information. Patient-level data transmitted to CDC must not contain personal
identifiers such as name, social security number, date-of-birth, street address, or medical record
number. Unique, non-personally identified event and patient IDs are critical for the success of
SSuN and specifically permit longitudinal monitoring of unique persons in Strategies A & B. To do
this reliably, the unique identifiers associated with individual patients and related health events
must be maintained over the full course of the cooperative agreement and must be static and
immutable over the project period. Moreover, because identifiers assigned to uniquely identify
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persons are transmitted to CDC, these IDs must not contain elements of the above listed personal
identifiers. All unique identifiers for patients and events must be developed and maintained
locally and may be (or may not, depending on state/local practice) the same IDs used in local
surveillance data management systems or electronic health records as locally determined.
Human Subjects Protections
The Associate Director for Science (ADS) of the National Center for Hepatitis, HIV, STD and TB
Prevention (NCHHSTP), reviews SSuN protocols. A Determination of Non-Research has been
obtained for SSuN Cycle 4 activities. SSuN activities continue to be exempted from CDC
Institutional Review Board (IRB) review because they constitute public health surveillance – a
disease control activity – and do not represent research activities. No incentives are provided
directly to patients for participating in SSuN activities, nor should any actual or perceived
consequences devolve to patients for non-participation or refusal. Post-award, all collaborating
health departments must assess their local requirements for similar determinations. Where
necessary, local IRB non-research exemptions or waivers should be procured, with the
understanding that any additional local requirements for patient consent must be carefully
balanced against public health surveillance needs and should not be burdensome to the extent
of precluding the jurisdiction’s full participation in SSuN activities or significantly compromising
compliance with CDC-approved protocols.
Confidentiality
To protect the confidentiality of all SSuN data, state and local surveillance program staff agree to
abide by standards embodied in, and documented by, the “Data Security and Confidentiality
Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs:
Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action”, available
here: http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf.
Funded jurisdictions are required to obtain a statement from their jurisdiction’s Overall
Responsible Party (ORP) for HIV surveillance to document compliance as part of the award
process and must obtain annual re-certification as part of annual project reporting. All names,
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street addresses, social security numbers, telephone numbers, or any other specific identifying
information maintained at the local level must be securely stored and be appropriately redacted
before transporting records to CDC. Data transmitted to CDC will contain only required
geographic information (county, state and census tract) as well as other demographic, clinical,
and behavioral data elements specified in SSuN protocols.
All record-level data transmitted to CDC by collaborators must be transported using encrypted,
secure transport methods approved by CDC (e.g., SAMS). Data stored at CDC is maintained on
secure servers with multi-layered access restrictions. SSuN data archived at CDC are available
only to staff in the Division of STD Prevention (DSTDP) on an “as needed” basis. SSuN surveillance
data, as with all national STD surveillance records, are governed by strict data re-release policies;
disclosure of any information that could be used to directly or indirectly identify any individual
on whom a record is maintained is strictly prohibited.
iii.
Full participation in all SSuN meetings, conference calls and collaborations:
SSuN collaborators are expected to take an active role with CDC and with their SSuN colleagues
from other sites, and to fully participate in individual and group discussions and scheduled
gatherings. The purpose of these meetings, conference calls and individual site consultations is
to assure that SSuN activities are implemented according to protocols, provide a regular forum
to discuss emergent issues in STD surveillance, address site-specific issues and collaborate in
analyses and dissemination of SSuN findings. SSuN collaborators may also be occasionally called
upon to serve as surveillance consultants to the Division of STD Prevention for expertise on issues
involving emergent and/or long-standing problems in STD surveillance at the local and national
level.
iv.
Participation in project evaluation and data quality assurance processes:
SSuN staff at CDC will provide recipients with SAS data structures, format libraries and SAS syntax
for edit checking and data quality assurance for all required datasets that must be applied prior
to transmitting data to CDC. These tools should be used by funded sites to assure that all data
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quality, structure and format issues are addressed – and corrections made – before data are
transmitted to CDC. Additional quality assurance processes will be deployed at CDC before data
are merged into the national datasets. SSuN collaborators are expected to actively participate in
data quality assurance processes and to collaborate with CDC staff in addressing any and all
deficiencies identified in datasets submitted to CDC.
Periodically, CDC may request that collaborators participate in initiatives designed to evaluate
SSuN activities, provide additional information about the effectiveness or efficiency of SSuN
surveillance methods and to provide quantitative or qualitative information to CDC for future
planning purposes. SSuN recipients are expected to collaborate with their CDC colleagues in
these important evaluation activities.
v.
Provision of technical assistance to state and local STD programs:
SSuN collaborators are expected to provide technical assistance on surveillance methods and
best practices to the state, county and local STD/HIV programs in their jurisdiction as part of
routine SSuN activities. SSuN collaborators are a rich source of information and surveillance
expertise and should proactively make themselves available to their local colleagues to improve
the overall quality of STD surveillance data, especially those data routinely reported to CDC
through the National Notifiable Disease Surveillance System (NNDSS). SSuN collaborators are
asked to develop formal, written processes to share lessons-learned locally and provide for data
sharing with HIV and STD surveillance programs to assure that SSuN data are used supplement
the completeness of existing STD and HIV case data reported to CDC. Additionally, SSuN data
should be used to enhance the quality of STD epidemiology reports developed and disseminated
locally to guide STD prevention and control efforts funded under PS19-1901, Prevention and
Control for Health Departments (STD-PCHD).
SSuN jurisdictions may also elect to propose funding under SSuN Strategy C to provide targeted
technical assistance to other jurisdictions in their region implementing enhanced and core STD
surveillance strategies funded under STD-PCHD. Such technical assistance will be identified and
delivered in collaboration with CDC’s PCHD Prevention Specialists, and will be fully documented
and evaluated as an integral part of this SSuN Strategy C focus activity.
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B.
CDC Responsibilities/Activities
Collaborators in the STD Surveillance Network are funded through a Cooperative Agreement
rather than a grant mechanism in recognition of the substantial involvement of CDC in the
development of activities, protocols and priorities for the network – consistent with the broader
goals of the Centers for Disease Control and Prevention, National Center for HIV, Viral Hepatitis,
STD, and TB Prevention, Division of STD Prevention. Substantial involvement by the SSuN Science
Officer, SMEs, Project Officer and other CDC collaborators includes:
•
Coordination and dissemination of protocols for SSuN activities
•
Facilitation of routine SSuN communications
•
Coordination of conference calls and annual collaborator’s meeting(s)
•
Provision of infrastructure for secure transport of data to CDC
•
Provision of technical assistance, including SAS licensure and SAS training (limited)
•
Monitoring of recipient progress toward achieving SSuN outcomes, including recipient implementation
of data quality assurance processes
•
Management of SSuN data warehouse or other CDC central data stores to support data provisioning for
collaborative analyses
•
Provision of guidance and technical assistance (where requested and/or identified by CDC) essential to
implementation of activities in compliance with protocols
•
Summary and aggregate reporting to CDC leadership and external stakeholders
•
Ensuring that analyses and dissemination of site-specific findings from SSuN surveillance activities are
conducted collaboratively by both CDC and appropriate colleagues at participating sites
•
Providing laboratory services for STD surveillance focus activities funded under Strategy C
•
Facilitating discussions with SSuN recipients to identify emerging trends/issues in STDs/HIV and sexual
health, STD surveillance technologies and methods and other issues that merit further investigation
•
Coordinating development, dissemination and approval of proposals for multi-site SSuN analytic
projects
•
Assisting co-authors and lead authors in the development of multi-site SSuN manuscripts
•
Facilitating CDC clearance for manuscripts and presentations based on multi-site SSuN findings
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•
Working with SSuN recipients to assure that all activities, at both the awardee and CDC level, adhere to
NHHSTP data security and confidentiality guidelines
Project Coordination and Performance Monitoring
The SSuN Project Officer will work with each recipient to implement routine performance
monitoring processes. CDC will provide periodic annotated progress reports to collaborators that
will summarize key performance metrics for the project overall and serve as the basis for
comparison of these same metrics across individual sites.
C.
Uses of SSuN Data
Data from SSuN are expected to improve local and national STD surveillance activities, contribute
to STD/HIV prevention and control programs, inform local and national STD policy-making and
increase understanding of the epidemiology of populations being diagnosed with STDs and
trends in persons seeking STD clinical services. Results and findings from SSuN are also intended
to guide other national STD surveillance projects and contribute to strengthening the human
resources and technical infrastructure for state and local STD surveillance.
SSuN is a surveillance network that is, in part, intended to be representative of persons being
diagnosed and reported with STDs in multiple participating geographic areas encompassing a
significant proportion of all STDs reported nationally. An important outcome of SSuN is to
disseminate findings in a timely and useful way. Many findings will be particularly useful at the
local level; other results will be more meaningful after the data from all SSuN collaborators have
been aggregated, cleaned and appropriately weighted for analysis where appropriate. SSuN
recipients are expected to analyze and disseminate their site-specific data and to use local results
to improve state and local surveillance reporting, inform STD-related health policy and improve
STD prevention and control efforts in their jurisdiction. The principles and guidelines presented
in this section are intended to assure that SSuN findings are disseminated widely and that all
SSuN collaborators have opportunities to fairly participate in the process of analyzing, presenting
and participating in the development of manuscripts for submission to peer-reviewed journals.
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SSuN Data Uses at the Individual Site Level
SSuN recipients retain all rights and stewardship responsibilities with regard to the SSuN data
collected and stored locally. Moreover, CDC data stewardship principles preclude sharing siteidentified data transmitted to CDC with internal or external parties without the explicit
permission of local collaborators contributing those data. Collaborators are strongly encouraged
to use their local SSuN data for routine reporting, novel descriptive or statistical analyses,
presentations and manuscripts submitted for publication.
CDC requests that SSuN funding be acknowledged (CDC-RFA-PS19-1907, STD Surveillance
Network, SSuN) if an analysis is presented or manuscript published that includes enhanced case
or clinic visit data normally transmitted to CDC as part of SSuN – or for an activity that was
substantively supported by SSuN funding through Strategy C. CDC clearance is not required for
site-specific data products, unless a CDC collaborator is included as a co-author. Sites are asked
to share local SSuN data products with CDC for inclusion in the SSuN bibliography. Moreover, it
is strongly encouraged that SSuN collaborators share their ideas and plans for local analysis and
publication with their SSuN colleagues at CDC and other sites through the SSUN proposal process;
there may be valuable opportunities to strengthen a single-site analysis by including multi-site
data. This collegial approach will also serve to inform and inspire colleagues who may wish to
conduct similar analyses and to create an environment that fosters collaboration, prevents
duplication of effort and fulfils SSuN’s primary mission of enhancing STD surveillance nationally.
Analysis of aggregate SSuN data (no identified site-level stratification)
SSuN Science Officer and CDC SMEs will have primary responsibility for generating reports,
coordinating authorship and publication of SSuN data aggregated across sites and will summarize
these data as requested by CDC leadership, in national surveillance reports, conference
presentations, peer-reviewed journals and other internal and/or external publications. SSuN
strongly values the insight of our funded jurisdictions and supports participatory analysis
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processes designed to provide SSuN collaborators the option of participating in all aggregate
analyses and data dissemination of national data. Yet CDC staff retain the prerogative to respond
rapidly to requests from DSTPD leadership for presentations of aggregate SSuN data in multiple
formats and/or publications without prior notice.
Reporting of aggregate SSuN data at the national level that displays no site-specific stratifications,
or only present ranges across de-identified sites, will not require co-authors or individual sitelevel approval or be subject to local clearance processes. However, all sites providing data used
in any such analyses will be formally acknowledged if representatives from that site are not
otherwise included as contributing co-authors. Reasonable effort will be made to propose such
analyses to the SSuN collaborators in advance and to solicit input and co-authorship for aggregate
analyses. Whenever non-CDC co-authors are included in SSuN manuscripts or presentations
based on aggregate data, SSuN promotes and respects adherence to local clearance
requirements when appropriate based on inclusion of a co-author from that jurisdiction.
SSuN Data Stratified by Site (site-level data presented)
All analyses that include data stratified by identifiable site, with the exception of figures
presented in DSTDP’s annual STD Surveillance Report, will be disseminated as formal proposals
to collaborators for discussion. Full participation as co-authors by SSuN collaborators is
encouraged in these analytic projects, but is not required. Co-authorship for SSuN purposes is
construed to include substantive involvement in planning, data management and analysis,
manuscript drafting, data visualization, methodologic decisions, implication discussions and
reviews of final draft products. Contribution of data by a funded SSuN jurisdiction, in the absence
of substantive involvement as described above, would not generally constitute sufficient
contribution to be included as a formal co-author, consistent with the guidelines of most peerreviewed journals.
Sites contributing data to identified, site-specific data products should identify an investigator to
be included in a “SSuN Working Group” designation if there are no formal co-authors from that
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site. “On Behalf of the SSuN Working Group” will be the last formally acknowledged co-author
on such manuscripts. Statements of approval for CDC clearance purposes are required of every
co-author or “SSuN Working Group” member for abstracts submitted for presentations and for
manuscripts submitted to journals for publication. We ask that all SSuN collaborators be
conscientious in responding promptly to requests for clearance approvals.
Proposals for Analysis
SSuN collaborators from funded jurisdictions and investigators, science officers and fellows at
CDC are all encouraged to develop proposals for analyses of SSuN data for consideration. In
general, proposals for analyses will be reviewed for approval twice a year by all collaborators, at
the annual collaborator’s meeting and on a mid-year all-site conference call.
Proposals for abstracts to be submitted to upcoming conferences may be reviewed more
frequently, or on an ad hoc basis. Non-response after two (2) weeks will be considered tacit
approval of the proposal, formally declining co-authorship and approval to use the site’s data
(with formal acknowledgement as described above). There is no limit to the number of proposals
that may be discussed and approved at the semi-annual meeting/conference call. However, the
SSuN Science Officer will work with investigators to consolidate proposed projects if there is
significant overlap between proposals. Completed abstracts for approved proposals should be
distributed to collaborators not less than one (1) month prior to the conference’s abstract
submission deadline; collaborators will be given a minimum of two weeks to review, provide
comments/edits, decide on co-authorship and provide clearance statement (if required), with
defaults for non-response as described above.
For proposals using only aggregate data (no site-specific stratification) to move forward, SSuN
sites whose data are being requested will be given an opportunity to review within the time
periods specified above, comment and formally elect to participate as co-authors or with
acknowledgement for the contribution of data. All data use proposals will generally be approved
by consensus, but may be subject to majority vote if necessary. Sites may elect to approve or
disapprove of a proposal, and may decline to have their site’s data included for reasonable cause.
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For proposals using site-specific data (site-identified stratifications presented) to move forward,
all SSuN sites will be given an opportunity to review and comment within the time periods
specified above. All sites contributing data must identify one co-author for participation, either
as a formal co-author or by inclusion in the “SSuN Working Group” designation. Sites may decline
to permit the use of their data for multi-site analyses but must provide rationale for such
decisions. Concurrent plans for a substantively similar site-level analysis by SSuN collaborators
will generally not be considered a robust rationale for failing to permit use of their national SSuN
data or for declining to participate in an approved SSuN multi-site analysis.
Occasionally, analyses may be proposed using longitudinal data from sites that are not currently
participating in SSuN, in addition to currently funded sites continuing from previous cycles.
Efforts will be made to contact previously participating PIs for co-authorship and approval;
current collaborators may also participate as co-authors for any such analyses with consensus of
the sites contributing data.
Proposals for multi-site analyses from investigators that are not SSuN-funded collaborators (local
interns, academic partners, etc.) must be sponsored by the Principal Investigator (PI) of the site
from which the proposal is submitted and must have the sponsorship of at least one CDC SSuN
Science officer or SME; if approved through normal processes by the SSuN collaborators group,
the proposing site’s PI will take responsibility for assuring full adherence to all appropriate data
security and confidentiality requirements.
In many cases, preliminary data may be needed to assess the merits or feasibility of a given
analysis. CDC project staff will work with investigators to conduct preliminary data exploration
on the national SSuN data repository resulting in simple frequency tables and/or crosstabs to
help inform the proposal; these data/tables will accompany the proposal distributed for review.
All submitted proposals and any included preliminary data visualizations should be considered
internal, privileged and confidential documents.
Proposals should address how the analysis will be used for public health purposes and the specific
objective, data to be used (data elements, time frame), methods of analysis and briefly address
the specific assumptions and how missing data may be dealt with. Collaborators will be provided
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with pending proposals at least two (2) working weeks prior to the PI meeting or mid-year
conference call. Non-response after two (2) weeks will be considered tacit approval of the
proposal, declining of co-authorship and approval to use the site’s data with formal
acknowledgement. A sample proposal form is included as Appendix 2.
Access to Analytic Data
SSuN project collaborators from funded jurisdictions and investigators, SSuN Science Officers,
SMEs, and colleagues or fellows from other divisions or centers at CDC are all encouraged to
develop proposals for analyses of SSuN data for consideration. SSuN staff will assist with simple
exploratory crosstabs in the proposal development stage if requested. However, full access to
analytic data will be provided contingent on approval of proposals; only data elements pertinent
to the proposed analysis will be shared and only records for the time periods proposed in the
analysis. Any SSuN data shared with external partners as part of an approved analysis proposal
will be securely transported to the site sponsoring the analysis, with agreement that SSuN data
will be afforded the highest level of protection at the receiving site, with limited access only for
the purposes approved in the initial proposal and only by persons identified in the proposal. Sites
agree to securely destroy (wipe) SSuN datasets after all analytic needs are fulfilled and further,
agree that no secondary release of record-level data is permitted. Any publication requiring
inclusion of full datasets as part of the publication process must be referred to the SSuN Science
Officer prior to the transfer of any SSuN datasets to 3rd parties. In general, such uses will not be
permitted.
D.
SSuN Memorandum of Agreement
Health department collaborators funded for SSuN Cycle 4 activities will be required to complete
a Memorandum of Agreement with CDC governing the jurisdiction’s intention to provide
required data, adhere to SSuN protocols for data collection and to fully participate in SSuN
collaborations as described in the cooperative agreement and this protocol document. A duly
executed copy of this MOA should be completed and forwarded to CDC within one month post
award. A template MOA is provided as Appendix 1.
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E.
Strategy A – STD Clinic-Based Sentinel Surveillance Activities
Purpose and Scope
Cycle 4 of SSuN builds on previous experience in enhanced facility-based surveillance from Cycles
1, 2, and 3. The primary objectives of Strategy A are; 1) monitoring trends in people seeking care
in STD clinics, and, 2) monitoring STD-related HIV prevention opportunities among persons
seeking care in STD clinics. The primary purpose of this protocol is to provide a consistent method
for SSuN recipients to use in conducting sentinel surveillance in STD clinics. Collection of data
from these settings should
produce high-quality, timely facility-based surveillance and
epidemiologic data to direct public health STD prevention and control efforts, and improve the
understanding of STD & HIV preventive services and intervention opportunities in STD-specific
clinical settings. State and local STD surveillance programs have a history of strong collaborations
with local STD clinics in their jurisdictions. Because SSuN data are critically dependent on the
quality of data, state and local STD surveillance programs are encouraged to optimize strategies
to ensure data completeness.
Methods
Population of Inference
The population of inference for the facility-based component of SSuN includes all clinic patients
presenting for care and/or STD preventive services in participating STD clinics.
Definition of STD clinics
STD clinics are operationally defined as any clinical facility providing timely comprehensive,
confidential and culturally sensitive STD care as the facility’s primary function. Clinics need not
be stand alone and may be integrated into broader practice settings. However, the selected
facility must have a specifically identifiable STD clinic and have the ability to identify and extract
records from their electronic health records system for patients specifically seeking STD clinical
services separately from any broader patient population. Additionally, at least one of the
proposed STD clinic sites must meet the volume requirement of at least 5,000 visits per year and
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provide active management of (or documented referral to) pre-exposure prophylaxis
(PrEP)/post-exposure prophylaxis (PEP) for eligible patients.
Data Management
Participating grantees will collaborate with selected STD clinical site(s) to obtain visit-level clinical
information, including all data elements specified in this protocol, for all patients who receive
STD and/or sexual health services in participating STD clinics. Required data elements and the
appropriate response coding for clinic records are included as Appendix 4. Data transmission will
be at the interval of every other month for the duration of the project period.
Data abstracted will include patients demographic, behavioral and clinical information collected
during all visit encounters. The clinical information collected will be primarily related to the
diagnosis of STD/HIV related conditions, provision of preventive care, treatment prescribed, and
laboratory records (tests and results).
Data abstraction will be performed to create the following five files:
•
Visit: SAS file containing visit-level records and include routinely obtained patient
demographics (e.g., age, sex, gender identity, race, etc.) behavioral (e.g., gender of sexual
partners, drug use, etc.), and clinical (e.g., symptomatic status, recent HIV testing and
results, use of PrEP/PEP, etc.) data associated with all visits.
•
Diagnosis: SAS file containing visit-level records that contain routinely obtained diagnosis
records associated with all STD clinic visits (e.g., pelvic inflammatory disease, chlamydia,
non-gonococcal urethritis, muco-purulent cervicitis, etc.)
•
Laboratory: SAS file containing visit-level records that contain routinely obtained STDrelated and pregnancy, if applicable, laboratory records performed that are associated
with all STD clinic visits.
•
Treatment: SAS file containing visit-level records that contain routinely prescribed STDrelated treatment records associated with all STD clinic visits.
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•
Metadata- SAS file containing information on facility-level characteristics for each
participating clinic or network of clinics (e.g., type of clinic, policies on STD screening,
billing)
Visit level records of patients from STD clinics will include a unique patient identifier (patient ID)
to ensure multiple visits by the same patient are captured and longitudinal tracking can be done
over the course of the cooperative agreement. This patient ID must be included as part of each
visit record. If applicable, it is strongly encouraged to use the same unique identifier for an
individual patient if there exists multiple participating STD clinics within a network in a single
jurisdiction. Each clinic encounter will also be assigned a unique event identification (event ID)
number for each visit. The non-name-based unique patient and event ID, should be assigned by
either the state or local health department or the sentinel facility, and is created solely for the
purposes of surveillance and is not itself a medical record number. The unique patient ID code
for the STD clinic patients are assigned and maintained by the participating facility and/or local
health department. CDC cannot use this number in the identification of individual patients
seeking care in these facilities. Records for all visits containing a unique patient ID and a unique
event ID, will be used to link all STD-related diagnoses, laboratory (including HIV) tests and
results, and treatments given that are captured in related SAS files. Each jurisdiction will also be
identified by a unique site code and every clinical facility will have its own unique facility ID code,
both of which will be prepopulated by CDC.
The visit file will serve as the ‘parent’ record as it serves as the record of the actual clinical
encounter. Each visit (parent) record must include the patient ID, event ID, site ID, facility ID and
visit date variables in correct values; null values will not be accepted for these variables. These
key variables will be used to link records from the diagnosis, treatment and laboratory files. All
records from these 3 files that do not link to a parent record are considered ‘orphan’ records.
These records should be reconciled at the local level before transmission of data to the CDC.
Facility-based characteristics included in the metadata file will be collaboratively defined by SSuN
collaborators post-award but should up updated yearly. Funded jurisdictions are expected to
maintain rigorous procedures to assure the quality and validity of data before submitting to CDC,
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including but not limited to, completing data verification, recoding and appropriately structuring
the data to facilitate merging into the national enhanced SSuN datasets.
Automated SAS edit checks will be provided by CDC and used to in order to assure high quality
data are being collected. Jurisdictions should apply these validation checks and fix the offending
records prior to transmission.
Patient Surveys
In addition to implementing visit-level data abstraction in STD clinics, recipients are expected to
implement periodic, brief patient surveys in STD clinics participating in SSuN Strategy A. These
surveys, conducted in collaboration with CDC staff, will aid in 1) gaining a better understand of
the access and utilization patterns of people who seek health services in STD clinics and 2)
assessing information not routinely captured in the clinic health record. At least one (1) survey
must occur in the first funding year with a minimum recruitment of 350 consecutive
patient/respondents. In years 2-5, we anticipate multiple surveys per year, each with a minimum
of 350 consecutive patients/respondents per survey. SSuN recipients may chose when in the
budget year to implement their survey(s), based on local considerations, but must allow sufficient
time to complete the required 350 surveys by the end of the budget year. CDC survey protocols
and survey questions may vary from year to year, allowing for emergent issues to be investigated
in a timely fashion.
Although recipients may propose paper-based or technology-assisted data collection methods,
the design must allow capture of voluntary, self-reported responses from all patients seen
consecutively during the survey administration interval. Patients should respond to the survey
prior to receipt of their clinical services (e.g., in the registration area/waiting room). Conducting
these periodic patient surveys can also provide the opportunity, if needed, for jurisdictions to
include supplemental questions related to issues of specific interest at the discretion of the
individual jurisdiction. However, this supplemental information would not be transmitted to CDC.
Patient duplication during the survey period is allowed, but only a single survey should be
administered/collected per clinic visit. It is preferred, though not required, that survey data be
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linked to the associated SSuN patient visit record through appropriate identifiers where feasible
(unique visit ID, medical record number, patient name, etc.). Jurisdictions may propose to pilot
various methods to link with clinical records in the first year. Recipients with multiple STD
specialty clinic sites contributing data to SSuN Strategy A should consider survey administration
in higher-volume clinics (>5,000 visits per year) and may propose rotating between participating
clinics with this volume annually as needed to fully represent the jurisdiction’s STD specialty clinic
population. Data entry of survey data (if needed based on local methods proposed) will be
accomplished at the STD clinic site, or may be aggregated at the recipient’s health department
for central data entry.
HIV registry matching
In this cycle of SSuN, recipients will be required to collaborate with selected STD clinical facilities
to conduct eHARS (or similar official, comprehensive HIV case registry) matching of clinic patients
(regardless of diagnoses) seeking care. Collaborating STD clinics are expected to provide patient
identifiers (e.g., first and last name, date of birth, social security number, race, sex, etc.). The
choice of identifiers to use in matching records is up to the recipient but in general, variables with
the greatest specificity should be used. The matching process will strictly be performed at the
recipient level; CDC will not conduct these matches nor receive patient identifiers. Although
jurisdictions will propose methods specific to their jurisdiction (e.g., software, matching
methodology), the expectation is that matching will be automated and tuned for maximum
efficiency. The details of this process, including the frequency of matching, will be finalized post
award.
All patient records should have a disposition for result of HIV registry match. In cases where there
is uncertainty or matching discrepancies are noted, a manual review of the matching variables is
strongly suggested. For patients that are matched to a record in the HIV registry, recipients are
asked to abstract patient-level data on the date of earliest indication of HIV infection and
documented mode of transmission in the HIV registry. This information will be populated in the
visit file (specific to patient’s visit record). In addition, recipients are required to obtain all HIV
diagnostic and HIV laboratory data that are available in the HIV registry for matched patients,
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including the earliest recorded initial HIV–positive diagnostic test date, HIV viral load
date(s)/result(s) and CD4+ date(s)/result(s) with specimen collection dates on or subsequent to
October 1st, 2018.
It is highly recommended that recipients collaborate with their CDC-funded HIV Surveillance units
to address reciprocal information sharing to assure that desired patient demographics, sexual
orientation, gender identify, HIV testing and or treatment are available to CDC-funded HIV
surveillance unit staff for related evaluations and to enhance the completeness of HIV case
surveillance data. There is no requirement for data abstracted from the HIV registry to be shared
back to clinical facilities for the purpose of patient-level interventions or public health actions.
However, if jurisdictions choose to develop processes by which to share data back with clinical
partners SSuN would have no objections otherwise.
Figure 1: Example of Jurisdiction-Level HIV Match Process Flow
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It is suggested that jurisdictions develop and maintain a separate patient index file for all patients
for matched cases at the recipient’s health department to obviate the need to rerun the patient
through a matching algorithm. However, if a previously matched patient presents to a
participating STD clinic for subsequent visits, the patient’s HIV laboratory (VL/CD4+) will need to
be updated based on the date of each additional clinic visit.
Data matching or linking records between data sources can be an important means of
strengthening STD and HIV surveillance data, including identifying co-infections, improving the
completeness of existing databases, and guiding public health program activities. Grantees will
be able to assess their local burden of co-infection among reported STD cases and patients
presenting for STD care in STD clinics. Matches will also enable CDC to do the following:
•
Evaluate HIV status among STD clinic patients diagnosed with or at risk for STDs and to
stratify by behavioral risk, diagnosing provider characteristics, geography and
demographics
•
Understand the proportion of STD clinic patients diagnosed with or at risk for STDs who
are HIV-negative and eligible for and receiving PrEP/PEP (at time of STD diagnosis) and to
stratify these outcomes by multiple demographic, behavioral and healthcare factors
•
Understand the proportion of STD clinic HIV-positive patients diagnosed with or at risk for
STDs who are HIV-positive and in HIV-primary care, on ART and virally suppressed and to
stratify these outcomes by multiple demographic, behavioral and healthcare factors
•
Provide relevant patient-level and aggregate information at the recipient level to assist
local HIV surveillance/prevention units to resolve selected NRR/NIR cases, better monitor
HIV care status and prevalence patterns, and to better understand gaps in and
opportunities for promotion and uptake of HIV prevention interventions.
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F.
Strategy B – Enhanced Case-based Population Surveillance SSuN
Purpose and Scope
Enhanced data collection on all reported cases of gonorrhea and adult syphilis (all stages)
provides a valuable supplement to national case notifications allowing assessment of key
surveillance data quality measures. Collection of HIV registry matching provides information
valuable for assessing progress toward HIV prevention goals and gaps in HIV preventive services
among persons diagnosed with STDs. Additional patient and provider data obtained on a
representative sample of gonorrhea cases allows for valid estimation of case characteristics often
missing or not present in routine cases reporting.
Cycle 4 of SSuN builds on previous experience in enhanced case-based surveillance and recipients
are required to implement 6 primary Strategy B activities:
a. Extraction, cleaning and recoding a full census of gonorrhea and adult syphilis cases
to a case dataset with enhanced data elements including case and patient
deduplication indicators,
b. Conducting look-back investigations on all reported cases of gonorrhea and adult
syphilis, including matching with HIV registry and aggregating all HIV/STD-related
laboratory observations associated with cases in a separate, related laboratory
dataset linked to the case records by unique event and patient IDs,
c. Selection of a random sample from this universe of reported cases of gonorrhea,
d. Brief provider investigations on cases selected in the random sample (beginning with
gonorrhea in year one) to obtain relevant clinical and STD treatment information,
e. Enhanced patient investigations of gonorrhea cases selected in the random sample.
f. Technical assistance within the STD program within their jurisdiction to improve
overall STD surveillance data quality, use of SSuN data to inform local STD
epidemiology and disease prevention and control.
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Methods
Generating a Random Sample of Cases
Collaborating health departments will develop the capacity to generate a random sample of all
cases of nationally notifiable STDs within the first three months of funding. The most effective
way to achieve this result is to modify local STD surveillance data management systems to
incorporate this functionality by creating a system variable associated with individual records of
confirmed cases/events. This variable should be populated with the results of a random number
generator (generally a system function that randomly generates number between 0 and 1.0)
which runs only once at the time the case is entered into their system, regardless of whether the
record is created automatically based on incoming laboratory data or manually based on review
of internal or external case or laboratory reports. Random number functions are available in SQL,
Oracle and most other database platforms.
A useful analogy is that as each case is entered into the system, dice are rolled and the result
frozen for that unique case; the ‘dice’ should not be rolled again once the initial result is recorded.
The variable or data element containing this ‘frozen’ random number must be permanently
stored in the underlying case/event records and available for export for use in constructing SSuN
datasets and for directing subsequent SSuN case investigations. Because this random number is
generated uniquely for each individual record, it is irrelevant whether subsequent investigations
determine that the case/event is a duplicate or if the case/event is out-of-jurisdiction.
Each system will have unique characteristics from the programming/development perspective,
but the end result must be a random number permanently associated with each unique case or
event record that can be used to select a sample for enhanced investigation regardless of any
subsequent disposition of that specific record.
Using Random Numbers to Assign Sample Status
Once a random number is associated with individual cases/events, this number will be used to
assign a sample indicator based on the desired sample fraction for cases of interest to SSuN
(which includes all gonorrhea, adult syphilis and also for chlamydia cases if the jurisdiction
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participates in the chlamydia focus investigation). This can be done either internally in the local
STD surveillance data management system or externally using SAS, SQL or other software.
For example, if a sample fraction of 30% is desired for gonorrhea cases, and the random number
generator returns a value of between 0 and 1.0, all records with a value between 0 and 0.3 should
be selected, and the sample indicator (P1_RandSamp) assigned a value of 1. For records with
values > 0.3, the sample indicator should be assigned a value of 0. All records with a sample
indicator =1 constitute a 30% random sample.
Consider that it may be desirable to have different sample fractions in different counties (or other
geographic units) based on available resources for follow-up or to balance workloads based on
morbidity levels. The same random number can be used, but the geographic unit would be
incorporated into the assignment of the sample indicator. For example; given three counties with
local IDs of 01, 02 & 03, and desired sample fractions of 10%, 20% and 50% , the sample indicator
would be assigned this way using SAS code:
P1_RandSamp=0;
If county=01 and (0 LE RandomNumber LE 0.1) then P1_RandSamp=1;
If county=02 and (0 LE RandomNumber LE 0.2) then P1_RandSamp =1;
If county=03 and (0 LE RandomNumber LE 0.5) then P1_RandSamp =1;
Note that this schema can be deployed using a macro that could get the fraction and county data
from an external source such as an excel workbook or other source to provide greater flexibility
in changing the sample fraction over time, by geographic area or by disease. SSuN recipients are
encouraged to develop and deploy flexible means of sampling cases wherever possible.
a. The ‘universe’ for assigning a random number will include ALL cases of laboratory
confirmed gonorrhea, chlamydia and adult syphilis cases diagnosed and reported from
ALL public and private sources within the geographic boundaries of the collaborating
jurisdiction.
b. Records should be individually assigned a random number at the time they are received
into the jurisdiction’s STD data management system (or batched in a timely manner daily,
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or at a minimum, weekly if randomization is performed external to STD data management
system) such that all records meeting the sampling criteria based on information
contained in the report (provider located in jurisdiction, laboratory confirmed diagnosis
of CT, GC or adult syphilis) are assigned a random number.
c. The ‘sample’ is assigned by comparing the random number to a predetermined sample
fraction based on the disease and geography (as locally determined, see above). A sample
variable (P1_RandSamp) with values of 0 and 1 should be assigned to determine
disposition of the record.
d. For initial SSuN Strategy B activities, follow-up of cases in the random sample of cases will
be restricted to gonorrhea
e. A sufficient volume of records should be included in the resulting random samples to fulfil
stated project objectives:
i.
for jurisdictions with >50,000 gonorrhea cases reported in 2018, the minimum
acceptable target for completed patient interviews is 2.5% of all reported cases;
ii.
for jurisdictions with 30,000 - 50,000 gonorrhea cases reported in 2018, the
minimum acceptable target for completed patient interviews is 3.0% of all
reported cases;
iii.
for jurisdictions with 10,000 - 30,000 gonorrhea cases reported in 2018, the
minimum acceptable target for completed patient interviews is 3.5% of all
reported cases;
iv.
for jurisdictions with <10,000 cases reported in 2018, the minimum acceptable
target for completed patient interviews is 4% of all reported cases;
v.
patient interview completion rate will be calculated as the ratio of completed
interviews to the number of cases in the sample;
vi.
interview completion rate target for SSuN investigations is 65%.
f. “Completed” patient interviews refer to complete or substantially complete (partial),
patient interview. An interview will be considered as ‘partial’ if complete demographic
and gender/number of sex partner information is obtained but other information is
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refused or the interview terminated prematurely. However, every effort must be made
to complete all data elements on the patient interview; periodic recipient performance
reviews will include assessments of missing or incomplete patient-reported data
elements.
g. Jurisdictions will conduct routine and frequent (e.g. quarterly) quality assurance activities
to assess the representativeness of their samples by disease, with particular attention to
equal probability of sampling by patient characteristics (at a minimum by sex, age, and
geographic region within jurisdictions and source of report).
h. Jurisdictions will assure that appropriate data are available on the universe of all reported
cases to calculate valid stratification and non-response weights for their sampled cases.
Extraction of Case, Laboratory, Treatment and Provider Records to SSuN Datasets
Gonorrhea and adult syphilis ‘records’ are defined to include provider case reports, laboratory
records or any other original source documents as appropriate given the specific surveillance
infrastructure in funded jurisdictions. Data for all reported adult syphilis and gonorrhea cases will
be extracted, recoded and formatted for inclusion in SSuN datasets. Each record must contain a
unique ‘event’ ID and a unique, static patient ID. Patient ID’s must uniquely represent a single
individual and must be static (i.e., must remain the same throughout the project period for any
given individual, unique patient to allow for tracking repeat and co-infection). Required data
elements and the appropriate response coding for case records are included as Appendix 4.
All laboratory data associated with gonorrhea and adult syphilis cases are to be extracted,
reformatted and assembled into a separate, related dataset related to the case data through
unique IDs. Required data elements and the appropriate response coding for laboratory records
are included as Appendix 4.
Unique provider records associated with reported cases of gonorrhea and adult syphilis will be
extracted and assembled into a separate, related dataset, updated twice annually. Records will
be linked to case records with unique provider number. Required data elements and the
appropriate response coding for provider records are included as Appendix 4.
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Case-level Look-Back Investigations (All gonorrhea and adult syphilis cases)
At a minimum, case records for gonorrhea and adult syphilis will be compared with existing
disease and laboratory registries to determine if the patient of record has previously been
reported (ever reported) to the department of health for GC, CT, Syphilis, viral hepatitis or TB
diagnoses occurring within 365 days of the specimen collection date/diagnosis date of current
GC diagnosis. This should be documented and included in the appropriate data elements the
SSuN record. If multiple diagnoses are found, only the most recent previous diagnosis needs to
be retained for the SSuN record. It should also be determined at this time whether the record
represents a ‘duplicate case record’, which is defined as a GC diagnosis (or for syphilis cases, a
syphilis diagnosis similarly staged) within the previous 30 days; if record is a duplicate of existing
report, this should be documented and included in the SSuN record as P1_CaseDup=1. For
duplicate cases/records, earliest report date and specimen collection date (used to determine
duplicate status) should be documented in the appropriate SSuN data elements.
Provider Investigations (All gonorrhea cases in the random sample)
Case records that meet the following criteria should be referred to brief provider investigations.
o Record represents case of confirmed gonorrhea case and is not a duplicate of a
previously reported case
o Diagnosing provider/facility is ascertained and is within funded jurisdiction
o Patient determined to reside within jurisdiction at the time of diagnosis
o Case falls within the random sample
For these investigations, the diagnosing provider is contacted to provide additional information
about clinical characteristics, treatment(s) prescribed, the specific care setting and demographics
of the patient. These investigations can be conducted and completed either by direct contact
with providers (phone) or through other methods such as secure fax, mail or other means as long
as confidentiality of patient information is strictly maintained. Provider investigations also
provide an opportunity to obtain more recent contact information necessary for completing
patient investigations, especially if this information is missing from initial laboratory or case
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reports. SSuN recipients must institute quality assurance and follow-up procedures to assure the
highest possible completion rate for provider investigations, including tracking investigation
status and periodic re-contact to assure provider completion.
Patient/Case Investigations (All gonorrhea cases in the random sample)
Criteria for referral to patient investigations (patient interview) will include:
o Record represents case of confirmed gonorrhea and is not a duplicate of a
previously reported case
o Patient determined to reside within jurisdiction at the time of diagnosis
o Initial case report or notification was received by health department within 60
days of the diagnosis (or specimen collection) date
Patient-level investigations/interviews may be conducted either by phone or in-person with a
minimum of four (4) documented attempts at various times (evenings/weekends, etc.) and using
a range of methods (SMS, phone calls, mail, etc.) to contact each patient referred for
investigation. Sites are required to develop local protocols and data collection instruments
(paper and/or electronic) for investigators, provide adequate training for conducting direct
patient contact and to address local human subject’s requirements as necessary.
All reasonable attempts must be made to obtain reliable contact information for cases eligible
for patient interviews. Methods for obtaining contact information for patients may include vital
record searches, registry searches, direct provider contact, social media (following local health
department conventions), driver’s license and/or vehicle registration registries if available.
Jurisdictions may also find it productive to integrate SSuN data collection into local partner
management and treatment assurance protocols to prevent duplicate patient and/or provider
contacts; SSuN-related data elements may be collected in the course of routine partner services
as long as these data are collected in a manner consistent with SSuN protocols.
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Data Management
Data obtained for the population component will come from numerous sources within the health
department and will need to be locally merged, recoded and appropriately structured to facilitate
merging into the national SSuN datasets. Figure 2 demonstrates a sample data flow for
conducting Strategy B activities.
Funded jurisdictions are expected to institute rigorous
procedures to assure the quality and validity of data elements before submitting data to CDC.
CDC will provide SAS data structures with variable names, lengths and types defined for all
requested datasets. Local data should be transformed to conform to these data structures and
include only the requested data elements, properly coded and in appropriate data formats.
Funded jurisdictions will complete data verification and validity checks on datasets prior to
transmission to CDC, including consistency checks to assure that data in the record is internally
rational (for example, that there are no records of males with cervical infection or pregnancy
indicated for males). In collaboration with data managers in each jurisdiction, CDC will prepare
syntax for data validation that will provide for the minimum data quality assurance required.
Jurisdictions will apply these validation checks and fix errors in records prior to transmission. In
cases where errors are repeatedly introduced from underlying, primary data sources that cannot
be corrected, an “exception” file should be maintained locally and applied to the dataset before
transmission to fix historical errors that recur because of the cumulative nature of SSuN data
processes.
Jurisdictions will provide clean, validated datasets, alternating facility and population component
data to CDC every month, such that each strategy’s component data is updated with new data
every two months and includes cumulative data back to the beginning of each calendar year. A
final, validated annual dataset will be transmitted each year (in March) and archived to become
the primary repository of that site’s annual reporting. These annual datasets will serve as the
basis for calculating analytic weights in the population component and should be preserved at
the local level as ‘frozen’ data for local analytic purposes.
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Figure 2: Jurisdiction-Level Record Process Flow for Strategy B Case, Provider and Patient
Data
HIV Registry Matching Requirements for Strategy B
All reported cases of gonorrhea and adult syphilis (all stages) are to be matched with the
jurisdictions HIV registry. For the purposes of SSuN, the jurisdiction’s “HIV case registry” is a term
expressly defined to mean eHARS, the CDC-provided surveillance data management system for
HIV case surveillance that constitutes the universe of HIV case data officially reported to CDC.
However, some jurisdictions may maintain supplemental case reporting or registry databases in
synchrony with the jurisdictions official eHARS repository; these may provide similar functionality
and validity for fulfilling SSuN’s HIV matching requirements as long as these data are
comprehensive, reflect the full geographic extent of SSuN activities within the funded jurisdiction
and allow for extraction of required SSuN data elements, including HIV-related laboratory
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information. Case data extracted for SSuN should be matched with the HIV registry periodically,
however a minimum requirement is that matches should be performed at least twice a year, with
one matching event coinciding with submission of annual, cleaned SSuN datasets (due annually
in March).
Jurisdictions should coordinate with their jurisdiction’s CDC-funded HIV Surveillance unit or
program to conduct periodic person-based matching, mindful that both STD and HIV case
registries are dynamic; new patients are added continuously as new diagnoses are reported.
Previously unmatched STD patients should be re-submitted to all subsequent matches to identify
subsequent HIV diagnoses/reports and to assure that complete information is available for all
gonorrhea and adult syphilis cases reported throughout the full period of the SSuN cooperative
agreement.
Registry matching processes (see Figure 1 above) will be performed only at the recipient level;
CDC will not receive patient names or DOB data. Although jurisdictions will deploy methods
specific to their jurisdiction (e.g., matching software, methodology, manual review processes),
all SSuN recipients are required to extract data on the earliest documented date of HIV infection,
and to obtain laboratory data (all viral load and CD4+ tests with specimen collection dates from
October 1st, 2018 forward) for all matching records from the HIV surveillance registry for inclusion
in SSuN datasets. SSuN recipients should consider the burden of these matching activities and be
prepared to provide resources appropriate to the planned frequency of matching. Moreover,
data of interest to the HIV Surveillance or HIV Prevention Programs which help to improve the
quality of HIV surveillance (risk information, current residence, etc.) or to identify patients who
may have lapsed from care should be routinely provided back to the HIV Surveillance unit as part
of SSuN matching activities.
Data matching or linking records between data sources can be an important means of
strengthening STD and HIV surveillance data, including identification of co-infections, improve
the completeness of existing databases, and guide public health program activities. Recipients
will be able to assess their local burden of co-infection among reported STD cases and patients
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presenting for STD care in key facilities. Matches will also enable CDC to investigate differences
across multiple sites and to:
•
Evaluate HIV testing among persons diagnosed with or at risk for syphilis, gonorrhea and
other STDs and to stratify by behavioral risk, diagnosing provider characteristics,
geography and demographics
•
Understand the proportion of persons diagnosed with or at risk for syphilis, gonorrhea
and other STDs who are eligible for and receiving HIV PrEP/PEP (at time of STD diagnosis)
and to stratify these outcomes by multiple demographic, behavioral and healthcare
factors
•
Understand proportion of HIV-positive persons diagnosed with or at risk for syphilis,
gonorrhea and other STDs who are in HIV-primary care, on ART and virally suppressed
and to stratify these outcomes by multiple demographic, behavioral and healthcare
factors
•
Provide relevant patient-level and aggregate information at the recipient level to assist
their jurisdiction’s CDC-funded HIV surveillance and prevention programs to resolve cases
with no risk reported (NRR), better monitor HIV care status of HIV-positive individuals,
monitor local prevalence patterns, track current residence and to better understand gaps
in and opportunities for promotion and uptake of high impact STD-related HIV prevention
interventions.
Technical Assistance to STD Surveillance Units/Programs
All SSuN recipients are expected to develop and maintain robust collaborations within their
jurisdictions with the STD prevention program (funded through STD-PSCHD, CDC-RFA-PS191901).
The purpose of these collaborations is to provide ongoing, substantive technical
assistance to improve the jurisdiction’s STD case surveillance, provide analytic and interpretive
data to enhance local programmatic action, collaborate in implementation of PCHD surveillance
activities (including enhanced gonorrhea surveillance) and to assure that SSuN funds are
leveraged to enhance STD prevention at the local level.
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G
Strategy C: STD Surveillance Focus Activities
Surveillance Focus Activities are intended to improve quality and use of surveillance data, explore new
methods for monitoring the burden of reportable and/or non-reportable STDs, investigate incidence of
sequelae and monitor adverse health outcomes of STDs across the full range of laboratory and provider
settings. SSuN recipients are required to apply for at least one (1) but no more than five (5) surveillance
focus activities in any given budget year. These activities will generally change annually, reflecting
divisional priorities and emergent issues. Protocols and methods may be recipient based or
collaboratively developed post award depending on the number of jurisdictions participating. The initial
Surveillance Focus Activities include:
Lymphogranuloma venereum (LGV) surveillance among persons seeking care in STD clinics
Applicants will collect remnant C. Trachomatis-positive (by NAAT testing) rectal swabs/specimens from
both symptomatic and asymptomatic male and female patients seeking care in clinics participating in
Strategy A for shipment to the CDC-DSTDP laboratory for testing to determine the prevalence of LGV
serovars (L1-L3).
•
•
Recipients may collect specimens continuously for a specified period of time, or sequentially until
200 specimens are obtained per participating STD clinic.
Recipients must be able to link specimens to SSuN clinic visit records through unique SSuN patient
and event IDs.
Expected outputs:
•
Dataset of IDs associated with all rectal swabs/specimens shipped to the CDC-DSTDP laboratory
with event IDs linking specimens to Strategy A datasets - transmitted per protocol to CDC
Enhanced case investigations among a sample of reported chlamydia cases in a high morbidity area
•
•
•
Following protocols specifying a limited set of pre-defined demographic, clinical and behavioral
data elements, recipients will conduct enhanced provider and brief patient follow-up
investigations on a random probability sample of reported chlamydia cases in a well-defined high
morbidity county, neighborhood planning area or health planning region within the recipient's
jurisdiction for two (2) discrete time periods per project year.
Recipients will use the same methods to select a random sample of chlamydia cases that they
employ for the selection of cases in Strategy B.
Recipients will collaborate with CDC to propose and employ separate patient interview
methodologies for each of the two (2) investigation periods (examples include traditional DIS
follow-up, SMS text messaging, secure on-line survey with unique ID code, phone-based survey
app, etc.). The purpose of this requirement is to evaluate the relative merits and costs of different
methods of patient contact; process information on contact methods and outcomes will be
evaluated locally, documented and reported with aggregate results to CDC. Additional guidance
will be provided for this focus activity post-award.
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Enhanced cases investigations among early syphilis cases reporting neuro, ocular and otic symptoms
Following SSuN protocols, recipients will conduct enhanced provider and patient follow-up on interviewed
early syphilis cases to identify signs and symptoms of neuro, otic, or ocular syphilis as well as treatment
provided and results of any clinical evaluations.
Expected outputs:
•
Data elements for provider and patient follow-up of adult syphilis cases interviewed should be
fully incorporated into Strategy B datasets and transmitted per protocol to CDC.
Syndromic surveillance for neuro, ocular and otic signs/symptoms to detect undiagnosed syphilis
Recipients will collaborate with CDC to propose and conduct active surveillance projects in a high volume
emergency departments, ophthalmology, neurology or other appropriate clinical facility in their
jurisdiction designed to apply a syndromic surveillance case definition to potentially identify patients with
neuro, ocular or otic symptoms not otherwise explained by other underlying causes for follow-up testing
and evaluation for syphilis. This activity will involve the active participation of an appropriate clinical
partner. Recipients of funding for this focus activity will collaborate with CDC in the creation of the
surveillance case definition, monitor project implementation in the clinical setting and to design and
conduct evaluation of the project.
Expected outputs:
•
Documentation of case definition and unique patient records queried - aggregate results
summarized and transmitted per protocol to CDC
Implementation of HL7 case reporting through NNDSS
Recipients will collaborate with CDC to implement STD and congenital syphilis (CS) message mapping
guides (MMGs) and complete the transition to HL7-based case reporting to CDC though the National
Notifiable Diseases Surveillance System (NNDSS) Modernization Initiative (NMI). Additional information
on NMI and the STD and CS MMG requirements can be found at https://www.cdc.gov/nmi/index.html.
Recipients funded for this focus activity will work with the Center for Surveillance, Epidemiology and
Laboratory Science (CSELS) at CDC to begin the on-boarding process and agree to implement STD and CS
message mapping guides for routine reporting of STD cases to CDC through NNDSS.
Expected outputs:
•
•
•
•
Implementation package showing NNDSS data cross-walk and HL7 mappings - transmitted per
protocol to CDC/CSELS
HL7 test records transmitted per protocol to CDC/CSELS
Limited production HL7 messages transmitted per protocol to CDC/CSELS
Year-to-date matching datasets in both NETSS and HL7 formats transmitted per protocol to
CDC/CSELS
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•
Cut-over to HL7 production for reporting of STDs to CDC through NNDSS
Technical assistance to STD-PCHD recipients implementing enhanced gonorrhea investigations
Recipients funded for this focus activity will work with CDC SSuN and Program Development and Quality
Improvement Branch (PDQIB) staff to identify technical assistance needs in neighboring non-SSuN funded
jurisdictions, design curricula and provide direct peer-to-peer assistance (facilitated through webinar,
conference call, materials sharing and [infrequently] through site visit) to health departments
implementing limited enhanced gonorrhea surveillance activities funded under STD-PCHD.
Expected outputs:
•
Documentation of technical assistance needs, gaps identified, communications and technical
assistance plans, summary results.
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H
Data Management
Transmission of Data to CDC
Required Strategy A, B and C (optional) datasets will be securely transmitted to CDC on a
staggered schedule. On the 15th of each month, sites will transmit each of the datasets on an
alternating basis. For example, on March 15th sites would send the Strategy A data and then on
April 15th, sites would send Strategy B data, alternating throughout the year. Data for each
transmission should be cumulative for that calendar year and complete through the last day of
the month from 2 months prior. For example, for data due on May 15, the dataset should contain
records from Jane 1st through March 30th. This allows approximately 6 weeks for case follow-up,
for data to be cleaned, properly coded and all quality assurance processes to be completed prior
to transmission. When the 15th falls on a holiday or weekend, datasets will be due the first
business day following the holiday. A data transmission schedule will be distributed to SSuN
collaborators post award.
Record-level data will only be transmitted to CDC following SAMS protocols. CDC will formally
acknowledge all data transmissions and communicate all validation results. Datasets failing to
comply with pre-determined data structures will be rejected, with notification to sites. Sites must
re-format, recode or resolve issues and retransmit corrected datasets within 5 working days to
remain in compliance with SSuN requirements.
Data Management at CDC
Datasets received at CDC will be validated and merged to the national SSuN database within two
weeks of receipt; the national dataset will be maintained current as of the end of the previous
reporting month for purposes of reporting process measures back to funded jurisdictions.
Funded sites will receive an individual summary report documenting the status of all datasets
received to date and identifying any datasets that were due and have not been received, and the
on-time status of all transmissions as part of grants management and quality assurance
processes.
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Appendix 1
Memorandum of Agreement for
Collection and USE of STD Surveillance Network (SSuN) Surveillance Data between
The Division of STD Prevention (DSTDP),
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP)
and
PURPOSE
The purpose of this agreement is to provide a mutually agreed framework between CDC and funded
entities for the collection, sharing and release of surveillance data collected as part of STD Surveillance
Network (SSuN) activities.
BACKGROUND & OBJECTIVES
The STD Surveillance Network is comprised of state/local and/or city health departments funded by
cooperative agreement (CDC-RFA-PS19-1907) to implement common protocols for enhanced and sentinel
STD surveillance. The purpose of SSuN is to improve the capacity of national, state, and local STD
programs to detect, monitor, and respond rapidly to trends in STDs through enhanced data collection,
reporting, analysis, visualization and interpretation of disease information. Data are collected locally by
funded jurisdictions following prescribed protocols, cleaned, formatted and transported to CDC for
merging into national datasets that will be used by SSuN collaborators and CDC subject matter experts for
a broad range of reporting and analysis as provided for in SSuN protocol documents. This Memorandum
of Agreement is intended to explicitly document concurrence of funded sites with SSuN data collection
protocols, procedures and guidelines for the protection and use of SSuN data.
STORAGE OF SSuN DATA
The health department identified above agrees to send to CDC appropriately de-identified datasets with
data elements (Appendix 4) as specified in SSuN protocols on all persons visiting collaborating STD clinics,
and for all persons diagnosed and reported with gonorrhoea and/or all stages of adult syphilis. Separate
SAS datasets will be required for clinic patient visits, diagnoses associated with patient clinic visits,
laboratory observations associated with patient clinic visits, treatments associated with patient clinic
visits, reported cases of gonorrhoea and adult syphilis, laboratory data associated with reported cases of
gonorrhoea and adult syphilis, treatment data associated with reported cases of gonorrhoea and adult
syphilis, and information on providers reporting cases of gonorrhoea and adult syphilis.
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Sites will send SSuN data through SAMS using specified encryption methods and biologic specimens (if
required for Strategy C activities) through approved carriers per CDC-supplied protocols. CDC agrees to
accept and securely store these data and specimens, accessible only to SSuN project or CDC laboratory
staff. Data will not be integrated into other datasets maintained by CDC and will at all times be stored on
secure servers with fully restricted access. Biologic specimens (if required for supplemental projects) will
be received directly by DSTDP’s Laboratory Reference and Research Branch.
To protect the confidentiality of persons reported with STDs, state and local surveillance program staff
and/or contractors agree to abide by the Data Security and Confidentiality Guidelines for NCHHSTP.
(http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf) and will be
required to document compliance as part of annual project reporting. Full names, street addresses, social
security numbers, telephone numbers, or any other specific identifying information will not be sent to
CDC.
Databases will contain geographic information at the census tract level as well as other
demographic, clinical, and behavioral data elements specified in SSuN protocols collaborative developed
by SSuN collaborators. Census tract data collected in the population component will be linked with US
census data (American Community Survey and decennial Census data) and all such internal datasets will
also be stored on secure servers with fully restricted access. A CDC Assurance of Confidentiality is being
sought for SSuN data; SSuN and CDC staff agree to adhere to these data protection standards at all times.
The Surveillance and Data Management Branch in the Division of STD Prevention is charged with the
responsibility of maintaining the security and confidentiality and the scientific integrity of all SSuN
databases, dataset and subsequent analyses. Appropriate CDC staff will be designated custodians of the
SSuN data and accept full responsibility for observance of all conditions of use and for establishment and
maintenance of CDC-standard security precautions to prevent unauthorized use. Other CDC staff in the
Division of STD Prevention may be granted access to dataset derived from SSuN data as needed for
legitimate data management or analytic purposes.
STD Surveillance Network Principal Collaborators will be promptly notified of any CDC personnel changes
that affect access to data collected and managed for this project. All CDC staff with access to SSuN data
will remain current with the annual Health and Human Services Information Security Awareness Training.
A record of the completion of security training for all CDC staff is maintained by the CDC Information
Technology Services Office (ITSO).
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CDC may retain SSuN data as long as the data are protected as described herein and local use of these
data to direct STD surveillance and prevention activities is ongoing. CDC will annually review the need for
the data with SSuN Principal Collaborators, and shall destroy all copies of the data if it is determined that
no further analysis will be conducted.
DATA RE-RELEASE & USE
Local collaborators retain full control of and rights to analysis, research, and publication of their locally
collected data, regardless of whether these data are also provided to CDC as part of SSuN activities.
However, collaborators agree to acknowledge CDC funding in publications resulting from analyses of data
collected through SSuN funding. Principal Collaborators may request and receive multi-site SSuN dataset
for specific analytic purposes provided the SSuN Project Officer and the Principal Collaborator (or
designated representative) of sites contributing data have reviewed and approved the analysis proposal.
Proposals for such analyses must include all of the information required in SSuN protocols prior to
consideration for approval.
AUTHORSHIP & ACKNOWLEDGEMENT
All collaborators are encouraged to participate in generating and proposing analytic ideas, conducting
analysis, drafting abstracts and manuscripts as first or with colleagues as co-authors. At least one coauthor from each site is strongly recommended for all analyses using site-specific or site-stratified data.
This agreement may be amended at any time in writing by mutual agreement of CDC and SSuN Principal
Collaborators. Such amendments will not be binding unless and until they are signed by personnel
authorized to bind each of the parties.
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Signatures:
_______________________________________________________________________________
Hillard Weinstock, MD, MPH
Chief, Surveillance and Data Management Branch,
Division of STD Prevention,
National Center for STD, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention
Date
______________________________________________________________________________
Mark Stenger, MA
Lead Science Officer – STD Surveillance Network (SSuN)
Surveillance and Data Management Branch,
Division of STD Prevention,
National Center for STD, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention
Date
______________________________________________________________________________
Marvin Fleming
Project Officer – STD Surveillance Network (SSuN)
Surveillance and Data Management Branch,
Division of STD Prevention,
National Center for STD, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention
Date
Collaborators:
I/We have read and agree to stipulations in the Memorandum of Agreement for collection, stewardship, uses and
transmission of data to CDC for CDC-RFA-PS19-1907, STD Surveillance Network (SSuN).
___________________________________________________________________________________
Health Department SSuN Principal (or Co-) Collaborator(s)
Date
Name:___________________________________
Name:___________________________________
Title:____________________________________
Title:____________________________________
Agency:__________________________________
Agency:__________________________________
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Appendix 2: Data Use/Analytic Proposal Template
SSuN Analysis Proposal Form
1) Date proposal initiated: _______/________/________
2) Proposal Submitted by:
SSuN Site Collaborator
DSTDP Staff
Other CDC Staff/Fellow
External/Academic Partner
3) Title of proposed Analysis:_____________________________________________________________
4) First Author Full Name:________________________________________________________________
5) Affiliation (SSuN Site, Division/Branch/Team, Academic Institution, etc.):
_____________________________________________________________________________________
(If applicable, include SSuN Principal Collaborator/CDC Project Officer sponsor here)
_____________________________________________________________________________________
6) Additional Collaborators/Investigators:
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
(Not binding. Final product may or may not include these, or may include additional co-authors.)
7) Intended audience for analysis: (e.g., abstract or manuscript, name of conference or meeting)
_____________________________________________________________________________________
8) SSuN Data to be used: (e.g., single site data (specify site); multi-site data (specify sites).
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
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_____________________________________________________________________________________
9) Specific analysis planned (describe intended methods):
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
10) How will this analysis be translated into program action?:
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
11) Proposed timeline:
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
12) Additional description or notes: (optional)
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
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Appendix 3: Sample Data Collection Templates (Strategy A)
Clinic Patient Survey – Sample Template
1. Is this your first time to this clinic?
[ ] Yes [ ] No
2. Do you feel that this clinic provides a welcoming and respectful environment?
[ ] Yes [ ] No [ ] Not sure
3. What are the reasons for your visit to this clinic today (choose all that apply)?
[ ] Health problem or symptoms
[ ] No health problems or symptoms, but came to get STD screening/check-up
[ ] Told to get checked by partner
[ ] Referred by health department/disease intervention specialist (DIS)
[ ] Follow-up visit
[ ] Came to get STD test results
[ ] Came to get HIV test
[ ] Came to get medication that I can take every day to prevent getting HIV infection before I am
exposed to the virus (PrEP)
[ ] Came to get medication that I can take right away because I think I was exposed to HIV in the
past few days (PEP)
[ ] Came to get contraception
[ ] Some other reason
Please specify ____________________
4. What is the main reason you chose this clinic for care (choose only one)?
[ ] Could walk in or get same day appointment
[ ] Cost
[ ] Privacy concern
[ ] Expert care
[ ] Embarrassed to go to usual doctor
[ ] Some other reason
Please specify ______________________
5. Where would you have gone today if this STD clinic did not exist (choose only one)?
[ ] I would have waited to see how I felt and then decided what to do
[ ] Community health center
[ ] Public clinic/ health department clinic
[ ] Family planning clinic
[ ] Private doctor’s office
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[ ] Urgent care clinic/walk in clinic
[ ] Hospital emergency room (ER)
[ ] Hospital outpatient department
[ ] School-based clinic
[ ] Some other place
Please specify ________________________
6. Is there a place that you USUALLY go to when you are sick or need advice about your health?
[ ] Yes [ ] No GO TO QUESTION #8
7. If YES, what kind of place do you go to most often (choose only one)?
[ ] Community health center
[ ] Public clinic/health department clinic
[ ] Family planning clinic
[ ] Private doctor’s office
[ ] Urgent care clinic/walk in clinic
[ ] Hospital emergency room (ER)
[ ] Hospital outpatient department
[ ] School-based clinic
[ ] Some other place
Please specify ________________________
8. Is there a place you USUALLY go to when you need routine care or preventive care such as a
physical exam or check-up?
[ ] Yes [ ] No GO TO QUESTION # 10
9. If YES, what kind of place do you go to most often (choose only one)?
[ ] Community health center
[ ] Public clinic/ health department clinic
[ ] Family planning clinic
[ ] Private doctor’s office or HMO
[ ] Urgent care clinic/walk in clinic
[ ] Hospital emergency room (ER)
[ ] Hospital outpatient department
[ ] School-based clinic
[ ] Some other place
Please specify _____________________________
10. Do you have health insurance (choose only one)?
[ ] Yes, parents’ insurance plan
[ ] Yes, government (Medicaid, Medicare, etc.)
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[ ] Yes, private insurance (through employer)
[ ] Yes, private insurance (purchased by yourself/healthcare.gov exchange)
[ ] No coverage of any type GO TO QUESTION # 13
[ ] Don’t know GO TO QUESTION # 13
11. If YES, would you be willing to use your health insurance for today’s visit?
[ ] Yes GO TO QUESTION # 13
[ ] No
12. If No, why not (choose all that apply)?
[ ] I do not want my insurance company to know
[ ] Insurance company might send records home
[ ] I do not want my parents/spouse/significant other to know
[ ] Usual doctor might send records home
[ ] I cannot afford to pay the co-pay or deductible
[ ] My insurance will not cover this visit
[ ] Some other reason
Please specify __________________________________
13. What sex were you assigned at birth on your original birth certificate?
[ ] Male
[ ] Female
[ ] Refused
[ ] Don’t know
14. Do you currently describe yourself as male, female, or transgender?
[ ] Male
[ ] Female
[ ] Transgender
[ ] None of these
15. How old are you? Age in years______
16. What is your ethnicity?
[ ] Hispanic or Latino
[ ] Not Hispanic or Latino
17. What is your race (choose all that apply)?
[ ] American Indian or Alaska Native
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[ ] Asian
[ ] Black or African American
[ ] Native Hawaiian or Other Pacific Islander
[ ] White
18. Which of the following best represents how you think of yourself?
[ ] Lesbian or gay
[ ] Straight, that is not lesbian or gay
[ ] Bisexual
[ ] Something else
[ ] I don’t know the answer
19. What is your current employment status (choose all that apply)?
[ ] Full-time employment
[ ] Part-time employment
[ ] Unemployed
[ ] Disabled
[ ] Student
[ ] Other
20. What is your highest level of school you have completed or the highest degree you have
received ?
[ ] Middle school
[ ] Some high school
[ ] High school diploma
[ ] GED or equivalent
[ ] Some college
[ ] College degree or higher
END CLINIC PATIENT SURVEY
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Appendix 3a: Sample Data Collection Templates (Strategy B)
Patient Interview
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Suggested Introductory Script – Verbal (Informal) Consent – GC Interview
HELLO, My name is________ and I am calling for the ________________health department about your
recent doctor’s appointment with _______________ (mention name & date of patient’s visit to reporting
provider/facility).
[Interviewer must assure that they are speaking to the appropriate person by confirming date of birth,
date of doctor visit, etc. Local DIS protocols should be followed with respect to initial patient contact
and confirmation of patient identity]
We are gathering information about people recently diagnosed with (gonorrhea/chlamydia) in
___________________(name of city/state) to help make sure that the best care is available and to help
prevent the spread of (gonorrhea/chlamydia) in the future. This project is being conducted by the
___________(health department) with funding from and in collaboration with the U.S. Centers for
Disease Control and Prevention.
Your name was randomly chosen from among all of the people recently diagnosed and reported to the
health department. I would like to ask some questions about your experience at your recent doctor’s
visit and about your recent health behaviors related to your diagnosis. These questions should only take
about 10 minutes and any information you give me will be kept strictly confidential.
You do not have to answer any question you do not want to, and you can end the interview at any time.
Your name will not be shared with anyone and all of the information we gather will be combined with
others so that no one individual can ever be identified. Is this a good time for you and would you be
willing to help with this important project?
[If patient agrees, go to Module 1, Question 14]
[If patient refuses]We’re sorry you don’t want to participate but thank you very much for your time
anyway!
[If patient agrees but states that it is not a good time:]
When would be a good time to call you back? __________________________
Is this the best telephone number to use for you? _______________________________________
[If patient states that they wish to call the interviewer back, provide your name HD affiliation and
phone number; ask the patient to confirm approximately when they will call]
Thank you, I look forward to hearing from you on _____________ (day) at ___________(time).
Interviewer Use Only: Was verbal consent obtained for interview?
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Y
N
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Process Information
1
Interviewer:______________________________ID#________
2
PatientID:___________________________________________
3
EventID:_____________________________________________
Contact Attempts:
4
Date___/___/______;
5 Outcome__________________________________________
Notes:______________________________________________________________________
6
Date___/___/______;
7 Outcome__________________________________________
Notes:______________________________________________________________________
8
Date___/___/______;
9 Outcome__________________________________________
Notes:______________________________________________________________________
10
Date___/___/______;
11 Outcome__________________________________________
Notes:______________________________________________________________________
12
Interview/Disposition Date ___/___/______
13
Phase 3 Investigation Disposition Code:
00- Investigation complete: patient contacted, interview completed
01- Investigation complete: patient contacted, partial interview completed
10- Investigation not complete: Phase 3 investigation pending
11- Investigation not complete: patient contacted, refused interview
12- Investigation not complete: patient contacted, language barrier.
22- Investigation not complete: patient did not respond contact attempts
33- Investigation not complete: patient contact not initiated because patient
resident in correctional, mental health or substance abuse facility.
44- Investigation not complete: patient contact not initiated because patient is
active military on foreign deployment.
55- Investigation not complete for other reason: Specify __________________
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Module 1 - Demographics
Interviewer Read: These first few questions are about you and where you live.
14 What is your age?
____ ____
[code in years]
888- Refused
15 Do you consider yourself to be…?
Please read choices:[Check only one]
1- Male (CIS-Man)
2- Female (CIS-Woman)
3- Transgender Woman (Transgender M to F)
4- Transgender Man (Transgender F to M)
Do not read:
5- Transgender (declined to specify)
6- Queer, Gender Non-Binary
8- Refused
16 Do you consider yourself to be Hispanic or Latino/a?
1- Hispanic (Go to Question 16.1)
2- Non-Hispanic (Skip to Question 17)
3- Unknown (Skip to Question 17)
4- Refused (Skip to Question 17)
16.1 Do you consider yourself to be…?
1- Mexican, Mexican Am., Chicano/a, Latino/a
2- Puerto Rican
3- Cuban
4- Central American (Guatemalan, Honduran, Nicaraguan, El Salvadoran)
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5- Other Hispanic Origin (SPECIFY) 16.2 _________________________________
6- Unknown
9- Refused
17 Which one or more of the following would you say best describes your race?
Please read all choices (except Other): [Check all that apply]
17
White
Y
N
U
R
18
Black or African American
Y
N
U
R
19
American Indian or Alaska Native
Y
N
U
R (If Yes, Go To 19.1)
19.1 Tribal Affiliation (SPECIFY) ______________________________
20
Y
Asian
20.1
1 - Asian Indian (India)
4 - Korean
2 - Japanese
R (If Yes, Go To 20.1)
3 – Chinese/Taiwanese
8 – West Asian (Mid-east) 9 – Other/Unk Asian 10 – Refused
Native Hawaiian or Other Pacific Islander Y N
21.1
U
5 - Filipina/o 6- Southeast Asian (Viet, Thai, Cambodian, Burmese)
7 - Indonesian
21
N
U
R (If Yes, Go To 21.1)
1 - Native Hawaiian 2 - Guamanian/Chamorro/Fijian/Chuukese/Carolinian
3 – Samoan/Tokelauan/Tongan/Yapese 4 – Niuean/Palauan/Pohnpeian
5- Kosraean/Marshallesse
22
Other Race
Y
N
6 - Other Pacific Island
U
9 - Refused
R (If Yes, Go To 22.1)
22.1 [probe and specify if no other response is appropriate]_____________________________
Do not read:
23
23.1
Refused all race information
Y
N
Where were you born…?
In the U.S.
(23.2) Specify State _______________________________
Outside of the U.S.
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(23.3) Specify Country ______________________________________
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Module 2 – Healthcare Experience
Interviewer Read: These questions are about your recent doctor’s visit (when you were tested for
[gonorrhea/chlamydia]) and about your access to medical care in general. [Interviewer should mention
specific provider, if known]
24 Do you have any kind of health care coverage, including health insurance, prepaid plans such as
HMOs, or government plans such as Medicare, Indian Health Services, the V.A. or Military?
1- Yes [GO TO 25]
2- No
3- Don‘t know / Not sure [SKIP TO 26]
4- Refused [SKIP TO 26]
[SKIP TO 26]
25 What kind of healthcare insurance do you have?
1- Private healthcare insurance provided by my employer
2- Private healthcare insurance I pay for myself
3- Public healthcare insurance like Medicaid, Medicare, or [insert state-specific
Medicaid-like plan name]
4- Active/retired military or dependent plan like the V.A. or military
5- Bureau of Indian Affairs/Indian Health Service/Urban Indian Health Board
7- Other
8- Don‘t know / Not sure
9- Refused
Specify 25.1 ___________________________________
26 Do you have one person you think of as your personal doctor or health care provider?
If ‘No’, ask: ‘Is there more than one, or is there no person who you think of as your personal doctor or
health care provider?’ (Note: if respondent identifies a facility or provider setting rather than individual,
then code response as 2)
1- Yes, only one
2- More than one (or a facility)
3- No
4- Don‘t know / Not sure
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5- Refused
27 Was there a time in the past 12 months when you needed to see a doctor but could not because of
cost?
1- Yes
2- No
3- Don‘t know / Not sure
4- Refused
28 When you went to see _______________ [interviewer: insert reporting provider, clinic or facility
name from case report] when you were diagnosed with (gonorrhea/chlamydia), did you need to pay
anything out-of-pocket, like a co-pay, deductible or cash payment, at the time of your visit? (Note: this
question is meant to determine if respondent had to pay any amount of money to the provider at the
time of visit; do not include billed amounts or deferred or waived charges.)
1- Yes
2- No
3- Don‘t know /Not sure / Don’t remember
4- Refused
28.1 Before you went to see _______________ [interviewer: insert reporting provider, clinic or facility
name from case report], did you have any unusual discharge or oozing from your (penis/vagina)? (Note:
this question is meant to determine if respondent had genital symptoms before their health care visit.)
1- Yes
2- No
3- Don‘t know /Not sure / Don’t remember
4- Refused
28.2 Before you went to see _______________ [interviewer: insert reporting provider, clinic or facility
name from case report], did you notice any unexplained sores or bumps on your (penis/vagina)? (Note:
this question is meant to determine if respondent had genital symptoms before their health care visit.)
1- Yes
2- No
3- Don‘t know /Not sure / Don’t remember
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4- Refused
28.3 Before you went to see _______________ [interviewer: insert reporting provider, clinic or facility
name from case report], did you have any pain or burning when you urinated? (Note: this question is
meant to determine if respondent had genital symptoms before their health care visit.)
1- Yes
2- No
3- Don‘t know /Not sure / Don’t remember
4- Refused
29 Did you go to the doctor that time because you were having symptoms or pains you thought might
be from an STD?
1- Yes [GO TO 30]
2- No [SKIP TO 31]
3- Don‘t know / Not sure / Don’t remember [SKIP TO 31]
4- Refused [SKIP TO 31]
30 How long did you have these symptoms or pains before you were able to see the doctor?
(Note: probe as needed to elicit most specific response.)
1- 1 Day
2- 2 to 6 days
3- 1 to 2 weeks
4- More than 2 weeks
5- Don‘t know / Not sure / Don’t remember
6- Refused
31 Before you went to the doctor that time, did any of your sex partners tell you that you might have
been exposed to an STD?
1- Yes
2- No
3- Don‘t know / Not sure / Don’t remember
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4- Refused
(Sites may omit the following question)
Are any of the following reasons why you went to ___________ [Interviewer: insert provider name] for
that medical visit instead of going somewhere else?
[Read all responses]
Did you go…
32. Because this is your usual/regular doctor.
Y
N
33. Because you could get seen for free.
Y
N
34. Because they take your insurance.
Y
N
35. Because you felt more comfortable about your privacy there.
Y
N
36. Because you could get seen right away.
Y
N
37. Because you wanted to see an expert specializing in STDs.
Y
N
38. Because this doctor is close to your house and easy to get to.
Y
N
39. Because you were embarrassed and didn’t want to go to your regular doctor.Y
N
40. Because I didn’t want the insurance papers/info sent to my home/parents. Y
N
41. Any other Reason? Y
N
(specify) 42.___________________________________
43. Refused all reasons
44 During that visit, did the doctor, nurse or anyone else talk to you about the importance of getting
your sex partners examined and tested for STDs?
1- Yes
2- No
3- Don‘t remember / Not sure
4- Refused
45 In the time since you found out that you had (gonorrhea/chlamydia), have you told any of your sex
partners that they may need to be tested or treated for (gonorrhea/chlamydia)?
1- Yes
2- No
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3- Don‘t Know / Not sure
4- Refused
Interviewer Read: “In some places, doctors, nurses or the health department may help you to get your
sex partners treated for (gonorrhea/chlamydia) by providing extra medications or prescriptions for your
partners.”
46 Did a doctor, nurse or someone at the health department offer to give you medications or a
prescription for you to give to any of your sex partner(s)?
from
1- Yes [GO TO 47]
2- No [SKIP TO QUESTION 52]
3- Don‘t know / Not sure [SKIP TO QUESTION 52]
4- Refused [SKIP TO QUESTION 52]
47 Who was it that offered you medications or prescriptions for your partners? Was it someone
your doctor’s office, someone from the health department or someone else?
1- My doctor’s office [GO TO 48]
2- The health department [GO TO 48]
3- Someone else [GO TO 48]
4- Don‘t know / Not sure [GO TO 48]
5- Refused [SKIP TO QUESTION 52]
48 Did you actually get the medications or prescriptions for your sex partners?
1- Yes [GO TO 49]
2- No [SKIP TO QUESTION 52]
3- Don‘t know / Don’t remember/ Not sure [SKIP TO QUESTION 52]
4- Refused [SKIP TO QUESTION 52]
49 Did you get extra medicine to give to your partner? Or did you get prescriptions that your
partners needed to have filled at a pharmacy?
1- I got additional medications [GO TO 50]
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2- I got prescription(s) [GO TO 50]
3- Don‘t know / Not sure [SKIP TO QUESTION 52]
50 Did you give the medications or prescriptions to at least one of your sex partners?
1- Yes, I gave them to at least one of my partner(s) [GO TO 51]
2- No, I did not give them to any of my partner(s) [SKIP TO QUESTION 52]
9- Refused [SKIP TO QUESTION 52]
51 Do you think at least one of your sex partners took this medication?
1- Yes, I think at least one of my partner(s) took this medicine
2- No, I do not think any of my partner(s) took these medicines
9- Refused
52 Did you get tested for HIV at the doctor’s visit when you were tested for (gonorrhea/chlamydia)?
1- Yes, I got an HIV test at that visit [GO TO 53]
2- No, I did not get an HIV test [SKIP TO 54]
3- Don‘t know / Not sure [SKIP TO 54]
4- Refused [SKIP TO 54]
53 What was the result of your HIV test?
1- My HIV test was Positive [GO TO 57]
2- My HIV test was Negative [SKIP TO 58.1]
3- Don‘t know / Not sure / Didn’t get my results [SKIP TO 58.1]
4- Refused [SKIP TO 58.1]
54 Have you ever been tested for HIV?
1- Yes [GO TO 55]
2- No [SKIP TO 58.1]
3- Don‘t know / Not sure [SKIP TO 58.1]
4- Refused [SKIP TO 58.1]
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55 When was your last HIV test? Just month and year is ok?
Month ________ [use probes and elicit best guess if patient is not sure]
Year __________ [use probes and elicit best guess if patient is not sure]
[If patient refuses to guess, enter ‘..’ for month and ‘….’ for year.]
56 What was the result of that HIV test?
1- My HIV test was Positive [GO TO 57]
2- My HIV test was Negative [SKIP TO 58.1]
3- Don‘t know /Not sure/Didn’t get results [SKIP TO 58.1]
4- Refused [SKIP TO 58.1]
57 When was your most recent visit to a doctor, nurse or other health care worker specifically
for HIV medical care? Just the month and year is ok.
Month ________ [use probes and elicit best guess if patient is not sure]
Year __________ [use probes and elicit best guess if patient is not sure]
(Note: Enter ‘99’ for month and ‘9999’ for year if patient is still unable to remember; enter ‘88’
and ‘8888’ if patient explicitly refuses to provide date, enter ‘77’ and ‘7777’ if patient has not
had first HIV primary care visit yet. DIS should provide referral to HIV care if indicated.)
58 Are you taking antiretroviral medicines to treat your HIV infection?
1- Yes [FEMALES GO TO 59, MALES SKIP TO 60]
2- No [FEMALES GO TO 59, MALES SKIP TO 60]
3- I don‘t know / I am not sure [FEMALES GO TO 59, MALES SKIP TO 60]
4- Refused [FEMALES GO TO 59, MALES SKIP TO 60]
58.1 When you were diagnosed with gonorrhea, did your health care provider discuss medications to
help you prevent getting HIV? This is often called PrEP, or pre-exposure prophylaxis.
1- Yes [GO TO 58.2]
2- No [FEMALES GO TO 59, MALES SKIP TO 60]
3- Don‘t know / Not sure [FEMALES GO TO 59, MALES SKIP TO 60]
4- Refused [FEMALES GO TO 59, MALES SKIP TO 60]
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58.2 Did your health care provider prescribe medications to help you prevent getting HIV?
1- Yes [GO TO 58.3]
2- No [FEMALES GO TO 59, MALES SKIP TO 60]
3- Don‘t know / Not sure [FEMALES GO TO 59, MALES SKIP TO 60]
4- Refused [FEMALES GO TO 59, MALES SKIP TO 60]
58.3 Did you fill a prescription or get medications to help you prevent getting HIV?
1- Yes [GO TO 58.4]
2- No [FEMALES GO TO 59, MALES SKIP TO 60]
3- Don‘t know / Not sure [FEMALES GO TO 59, MALES SKIP TO 60]
4- Refused [FEMALES GO TO 59, MALES SKIP TO 60]
58.4 Are you currently taking medications to help you prevent getting HIV?
1- Yes [FEMALES GO TO 59, MALES SKIP TO 60]
2- No [FEMALES GO TO 59, MALES SKIP TO 60]
3- Don‘t know / Not sure [FEMALES GO TO 59, MALES SKIP TO 60]
4- Refused [FEMALES GO TO 59, MALES SKIP TO 60]
59 Were you pregnant at the time you were told that you had (gonorrhea/chlamydia)?
1- Yes, I was pregnant at that time
2- No , I was not pregnant at that time
3- Don‘t know / Not sure
4- Refused
Module 3 – Behaviors
Interviewer Read: “The following questions are about your sexual health and behaviors. Not all of these
questions may apply to you but we have to ask them for everyone – please let me know if a specific question
does not apply and we can move on to the next one. Remember, everything you tell me is strictly confidential
and will not be shared except when combined anonymously with the information from all of the other people
we talk with.”
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60 During the past 12 months, have you had sex with only men, only women, or with both men and
women?
1- Men only
2- Women only
3- Both men and women
4- Unknown
9- Refused
60.1 During the past 12 months, have you had sex with a transgender man or transgender woman?
1- Yes
2- No
3- Don‘t know / Not sure
4- Refused
61 Do you consider yourself to be…?
[Read all choices]
1- Heterosexual/Straight (not Gay or Lesbian)
2- Gay/Lesbian/Homosexual
3- Bisexual
4- Other/Don’t Know
[Do not read]
9- Refused
62 Thinking back to the 3 months before you were diagnosed with (gonorrhea/chlamydia), how many
MEN did you have sex with during that time? _________ [Probe: “It’s ok to guess if you don’t know
exactly.”]
9999- Refused
63 Thinking back to the 3 months before you were diagnosed with (gonorrhea/chlamydia), how many
WOMEN did you have sex with during that time? _________ [Probe: “It’s ok to guess if you don’t know
exactly.”]
9999- Refused
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Based on responses to number of sex partners, EPT questions and to patient’s knowledge of their partner’s
treatment status, DIS may facilitate EPT following local protocols at the conclusion of the interview. Please
document EPT or other partner services provided to the patient in question 74 at the end of the interview.
Read: Regardless of your previous answers about getting extra medications or prescriptions…
If patient reports only a single sex partner:
63.1 To the best of your knowledge, was your sex partner treated?
1- Yes, definitely
2- Yes, probably
3- Don‘t know / Not sure
4- No, probably not
5- Refused
If patient reports multiple sex partners:
63.2 To the best of your knowledge, would you say that all of your sex partners were definitely treated, at
least one of your partners was definitely treated, or that none were treated?
1- All definitely treated
2- At least one definitely treated
3- At least one probably treated
4- Not sure
5- Probably none treated
6- Refused
64 In the past 12 months, have you given drugs or money in exchange for sex, or received drugs or
money in exchange for sex? By sex we mean any vaginal, oral, or anal sex.
1- Yes
2- No
3- Don‘t know / Not sure
4- Refused
64.1 In the past year, how often have you used prescription pain medications – even if they were not
prescribed for you?
1- Never
2- Once or Twice
3- Monthly
4- Weekly
5- Daily or Almost Daily
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9- Refused
64.2 In the past year, have you used any injection drugs such as heroin, cocaine or meth?
1- Yes [GO TO 64.3]
2- No [SKIP TO 65]
3- Don’t Know/Can’t Remember [SKIP TO 65]
4- Refused [SKIP TO 65]
64.3. In the past year, did you inject…(read all, check all that apply)?
1- Heroin
2- Cocaine/Crack
3- Crystal Meth/Methamphetamine/Methadrone
4- Oxycodone/morphine/Fentanyl/Carfentanil/some other opioid
5- Other not listed, specify, 64.4 ________________________________
6- Don’t Know/Can’t Remember
9- Refused
Interviewer Read: “The next few questions are about the most recent time you had sex and about the person
you had sex with. By sex we mean any vaginal, oral or anal sex.”
65 When was the last time you had sex with someone?
1- In the last week
2- More than 1 week ago but within the last month
3- More than 1 month ago but within the last 2 months
4- More than 2 months ago
5- Don’t know / Not sure
9- Refused
66 Thinking back to that last time you had sex, was the person you had sex with…?
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Read all, select appropriate response:
1- Cis-Male
2- Cis-Female
3- M-F Transgender
4- F-M Transgender
Do not read:
5- Unknown
9- Refused
67 Thinking back to the last person you had sex with, how old do you think that person is? If you don’t
know for sure, it’s OK to make your best guess. [Note: probe with age groups, older, younger, etc.
Attempt to elicit single number if at all possible.]
_________ (years)
888- Unknown/Couldn’t Guess
999- Refused
68 Would you say that person is Hispanic/Latino/a? If you don’t know for sure, it’s OK to make your
best guess.
1- Yes, Hispanic
2- No, Not Hispanic
8- I don’t know/Can’t Guess
9- Refused
69 Thinking back to the last person you had sex with, what race would you say that person is? If you
don’t know for sure, it’s OK to make your best guess.
Read all, select best response:
1- White
2- Black
3- AI/AN
4- ASIAN
5- NH/OPI
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6- Multiple races
7- Other race
Do not read:
8- I don’t know/I can’t guess
9- Refused
70 Thinking back to the last person you had sex with, do you know if that person HIV positive?
1- I know this person is HIV+
2- I know this person in HIV-
3- I don’t know this person’s HIV status
4- Refused
71 Thinking back to the last person you had sex with; do you think you will have sex with this person
again?
1 Yes
2 No
3 Don‘t know / Not sure
4 Refused
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SSuN Interview Conclusion Script
If no additional partner management activity:
That’s all the questions we have – thank you for your time and for your help with this important project.
Do you have any questions for me before we end? Remember, everything we talked about today is
strictly confidential.
If referring to partner management or eliciting partners: proceed with local partner services protocol.
Optional Partner Services / Other Referrals Provided (if applicable)
72 Did interviewer/DIS provide EPT/PDPT to patient?
1 Yes
2 No
73 Number of partners EPT provided for ________
74 Did interviewer/DIS provide any other partner services to patient (DIS referral, partner notification,
risk reduction counseling, HIV testing referral, etc.)?
1 Yes
2 No
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Appendix 3c: Sample Data Collection Templates (Strategy A, Patient Survey)
Appendix 4: SSuN Strategy A & B Data Dictionaries and Coding Manuals
Strategy A – Visit Dataset
DE# OMB
DE Name
Description________________________________________________
1
Y
F1_FacilityID
Unique facility identifier
This ID should be supplied by the site and is a unique facility identifier from
underlying surveillance systems or may be generated specifically for SSuN.
Regardless of source, this ID must be unique and allow for longitudinal tracking
of the facility. This data element MUST NOT be ‘null’ or contain missing values.
2
Y
F1_SiteID
Unique site code
BA=Baltimore (Cycle II, Cycle III, Cycle IV)
CB=Columbus Ohio (Cycle IV)
CA=California (Cycle II, Cycle III, Cycle IV)
FL=Florida (Cycle III & Cycle IV)
IN=Indiana (Cycle IV)
MC=Multnomah County (Cycle III &Cycle IV)
NY=New York City (Cycle II, Cycle III, Cycle IV)
PH=Philadelphia (Cycle II, Cycle III, Cycle IV)
SF=San Francisco (Cycle II, Cycle III, Cycle IV)
WA=Washington (Cycle II, Cycle III, Cycle IV)
UT=UTAH (Cycle IV)
LA=Louisana (Cycle II)
VA=Virginia (Cycle II)
AL=Alabama (Cycle II)
CO=Colorado (Cycle II)
CH=Chicago (Cycle II)
MA=Massachusetts (Cycle III)
MN=Minnesota (Cycle III)
This data element MUST NOT be ‘null’ or contain missing values.
3
Y
F1_PatientID
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Unique patient identification number assigned by site
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This ID should be supplied by the site and may be a unique patient identifier from
underlying surveillance systems or may be generated specifically for SSuN.
Regardless of source, this ID must be unique and allow for longitudinal tracking
of patients within facilities. This data element MUST NOT be ‘null’ or contain
missing values.
4
Y
F1_Visdate
Date of clinic visit
This data element MUST NOT be ‘null’ or contain missing values except fo HIV
eHARS lab match records.
5
Y
F1_EventID
Unique visit identification
This record ID should be supplied by the site and may be an event or
6
Y
F1_sex_Birth
What is the patients assigned sex at birth?
1= Male
2= Female
3=Intersex
4=Unknown
9=Not Captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
7
Y
F1_Gender
What is the patient's gender?
1= Male
2= Female
3=Transgender M to F
4=Transgender F to M
5=Transgender unspecified
6= Other
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
8
Y
F1_Age
How old is the patient?(Age in years).
If age is unknown or missing, use null value.
9
Y
F1_Hisp
Is the patient of Hispanic ethnicity?
1= Yes
SSuN Cycle 4 (Version 12.2)
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2= No
9= Not captured
10
Y
F1_AIAN
Is the patient American Indian or Alaskan Native?
1= Yes
2= No
9= Not captured
11
Y
F1_Asian
Is the patient Asian?
1= Yes
2= No
9= Not captured
12
Y
F1_PIH
Is the patient Native Hawaiian or Pacific Islander?
1= Yes
2= No
9= Not captured
13
Y
F1_Black
Is the patient Black?
1= Yes
2= No
9= Not captured
14
Y
F1_White
Is the patient White?
1= Yes
2= No
9= Not captured
15
Y
F1_Multirace
Is the patient Multirace?
1= Yes
2= No
9= Not captured
16
Y
F1_Otherrace
Is the patient another race not listed above?
1= Yes
2= No
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9= Not captured
Indicate yes for all of the race/ethnic questions that apply. A response of 9
indicates the information is not captured/ collected by the facility or is not
provided to SSuN. Response should be null if (1) race is collected by the facility
but is unknown for this record, or (2) a response of “no” is not collected
separately.
17
Y
F1_Insurance
What is the primary health insurance status of the patient?
1= Insured, Public only
2= Insured, Private only
3= Insured, Multiple types
4=Unknown type
5=Uninsured
9= Insurance status not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected but is unknown for this record.
18
Y
F1_Visit_type
Type of clinic visit
1 = Clinician
2= express/fast track
8= Other
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or not provided to SSuN. A response of null indicates that the information
is collected but is unknown for this record.
19
Y
F1_Reason_visit
What was the primary purpose of the visit?
1= Symptomatic/new problem
2= Treatment only
3= Follow-up
4= Family planning
5= STD/HIV screening only
6= Prenatal care
7=PrEP Visit
8= Other
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected but is unknown for this record.
SSuN Cycle 4 (Version 12.2)
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20
Y
F1_Pregnant
Is the patient currently pregnant?
1= Yes
2= No
3= Patient does not know/ not sure
9= Not captured
If information is collected but patient is not sure, then appropriate response is 3.
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values allowed for men or if information is
collected by the facility but unknown for this record.
21
Y
F1_Sympt
Does the patient have STI symptoms?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
22
Y
F1_Contact_STD
Was the patient a contact or exposed to a STD?
1= Yes, to gonorrhea
2= Yes, to chlamydia
3= yes, unknown
4=Yes, Other STI
5= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
23
P
F1_Pelvic_exam
Was a pelvic exam performed?
1= Yes
2= No
9= Not captured
SSuN Cycle 4 (Version 12.2)
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A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values allowed for men or if information is
collected by the facility but unknown for this record.
24
Y
F1_MENSEX
How many male sex partners has the patient had in the last 3 months?
If number of male sex partners is unknown, missing, or not captured, use null
value.
25
Y
F1_FEMSEX
How many female sex partners has the patient had in the last 3
If number of female sex partners is unknown, missing, or not captured, use null
value.
26
Y
F1_TRANSEX
How many transgender sex partners has the patient had in the last 3 months?
If number of female sex partners is unknown, missing, or not captured, use null
value.
27
Y
F1_MSM_12
Does the patient (male) have a history of having male sex partners in the
previous 12 months?
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button), or 3(patient is a female).
1= Yes
2= No
9= Not captured
28
Y
F1_SEXOR3
Has the patient had sex with men only, women only or both men and women?
1= Men Only
2= Women Only
3= Both men and women
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
29
P
F1_SEXOR3TG
Has the patient had sex with a transgender man or woman?
1= Yes
2= No
9= Not captured
SSuN Cycle 4 (Version 12.2)
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A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
30
Y
F1_NUMSEX3
How many sex partners has the patient had in the past 3 months?
If number of sex partners is unknown, missing, or not captured, use null value.
31
Y
F1_SEXUALITY
Does the patient consider him/herself to be gay (homosexual), straight ?
1 = gay/lesbian/homosexual
2= straight/heterosexual (not Gay or Lesbian)
3= bisexual
4= Other
9 = Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the
information is collected by the facility but is unknown for this record.
32
Y
F1_NewSex
Did the patient have a new sex partner in last 3 months?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the (1)
information is collected by the facility but is unknown for this record or (2) that
there was not an opportunity for a “no” response (radio button).
33
Y
F1_Rectal_exposure
Does the patient report receptive anal sex with a male in the last 3 months?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the (1)
information is collected by the facility but is unknown for this record or (2) that
there was not an opportunity for a “no” response (radio button).
34
Y
F1_Oral_Sex
Did the patient engage in receptive oral sex in last 3 months?
1= Yes
2= No
9= Not captured
SSuN Cycle 4 (Version 12.2)
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A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the (1)
information is collected by the facility but is unknown for this record or (2) that
there was not an opportunity for a “no” response (radio button).
35
P
F1_condom
Does the patient report receptive anal sex without a condom with a male in the
last 3 months?
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the (1)
information is collected by the facility but is unknown for this record or (2) that
there was not an opportunity for a “no” response (radio button).
1= Yes
2= No
3= Unsure/ doesn’t know
9= Not captured
36
Y
F1_HIV_partner
Does the patient report having sex with a known HIV positive partner in the last
12 months?
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. A response of null indicates that the (1)
information is collected by the facility but is unknown for this record or (2) that
there was not an opportunity for a “no” response (radio button).
1= Yes
2= No
3= Unsure/ doesn’t know
9= Not captured
37
Y
F1_IVDU
Does the patient report use of illicit injected drugs in the past 3 months?
1= Yes
2= No
3= Patient not sure/ unknown
4= Not captured
38
Y
F1_OPIOD
Does the patient report use of opioids (but not under a physician's orders) in the
past 3 months?
1= Yes
2= No
3= Patient not sure/ unknown /refused
4= Not captured
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39
Y
F1_PrEP
Is the patient currently on or taking PrEP?
1= Yes
2= No
9= Not captured
40
P
F1_PEP_referral
Was the patient recommended for or given PEP at the STD clinic?
1= Yes
2= No
3= No, but a referral to outside clinic was given
41
Y
F1_PrEP_referral
Was the patient referred for PrEP?
1= Yes
2= No
3= No, but a referral to outside clinic was given
42
Y
F1_Partner_tx
Was the patient prescribed or given medication for expedited partner therapy?
A response of 9 indicates that EPT is provided by the facility, but information is
not captured or collected or is not provided to SSuN. A response of null indicates
that the (1) information is collected by the facility but is unknown for this record,
(2) facility does not provide EPT, or (3) information is collected by the facility but
there is not an opportunity for a “no” response (radio button).
1= Yes
2= No
9= Not captured
43
Y
F1_SXRectal
SSuN Cycle 4 (Version 12.2)
Does the patient report rectal symptoms (e.g., discharge, rectal pain) today?
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A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
1= Yes
2= No
9= Not captured
44
Y
F1_SXPharyngeal
Does the patient report any oral symptoms (e.g., sore throat) today?
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
1= Yes
2= No
9= Not captured
45
P
F1_SXAbdomen
Did the patient report abdominal pain?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
46
Y
F1_SXDysuria
Did the patient report dysuria?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
47
Y
F1_SXDischarge
SSuN Cycle 4 (Version 12.2)
Did the patient report a vaginal/anal/urethral discharge?
1= Yes
2= No
9= Not captured
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A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
48
Y
F1_SXLesion
Did the patient report a genital lesion?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
49
Y
F1_PEDischarge
Was there a vaginal discharge seen on physical exam?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button), or 3(patient is a female).
50
Y
F1_PEAbdomen
Was lower abdominal pain/tenderness reported on exam?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button), or 3(patient is a female).
51
Y
F1_CMT
Was there cervical motion tenderness on exam?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button), or 3(patient is a female).
SSuN Cycle 4 (Version 12.2)
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52
Y
F1_Adnexal
Was there adnextal tenderness on exam?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button), or 3(patient is a female).
53
P
F1_HIVTest
Has the patient ever been tested for HIV? (excluding HIV testing on today’s
visit)?
1= Yes
2= No
3= Patient does not know/ not sure
9= Not captured
If information is collected by the facility but patient is not sure, then appropriate
response is 3. A response of 9 indicates the information is not captured or
collected by the facility or is not provided to SSuN. Null values allowed if
information is collected by the facility but unknown for this record.
54
Y
F1_HIVTestdate
When was the patient's most recent test for HIV (month and year)? (excluding
HIV testing on today’s visit)?
Null values are allowed if (1) response to F1_HIVTest is either 2, 3, 9 or (2) patient
does not know/ or not sure of the date of most recent HIV test. This should be
coded as character data (“MM/YY”) with missing information as “../..” or “../YY”
55
Y
F1_HIVResultlast
What was the result of the patient's most recent test for HIV (excluding HIV
testing on today’s visit)?
0 = Negative
1 = Positive/preliminary positive
2 = Indeterminant
3= Patient does not know/ not sure
9 = Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null value are allowed if (1) response to
F1_HIVTest is either 2, 3,9 or (2) patient does not know/ or not sure of the result
of the most recent HIV test.
SSuN Cycle 4 (Version 12.2)
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56
Y
F1_HIVTest_refuse
Did the patient refuse an HIV test today?
1= Yes
2= No
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
57
P
F1_HregMatch
Was eHARS registry match done for this patient?
This data element may be initially coded as ‘2’ if the grantee conducts a batch
match with their HIV registry and the case is reported before that batch is
processed. This information can be updated in the SSuN record in the next data
transmission following the match. This data element should not be ‘null’ or
contain missing values.
1=Yes
2=No
58
Y
F1_HIVcare
Is the patient currently in HIV care?
1=Yes
2=No
3= Patient is not HIV positive
4= Unknown
9= Not captured
59
P
F1_HregMatchStat
Did this patient match a registry entry in eHARS?
This data element may be initially coded as ‘3’ if the grantee conducts a batch
match with their HIV registry and the case is reported before that batch is
processed. This information can be updated in the SSuN record in the next data
transmission following the match. This data element should not be ‘null’ or
contain missing values.
1=Matching Record Found
2=No Matching Record
3=Match Not Performed
60
P
F1_HregID
Unique record number from HIV registry (such as stateno from eHARS).
This data element should not be ‘null’ or contain missing values if a matching
record is present in eHARS
61
P
F1_HDXMOYR
What is this patient's earliest indication of HIV positive result?
SSuN Cycle 4 (Version 12.2)
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This information can be obtained from the eHARS person table (HIVPMOYR). If
eHARS match found. This should be coded as character data (“MM/YY”) with
missing information as “../..” or “../YY”
62
P
F1_EXPMOD
Exposure mode from HIV registry.
This data element should not be ‘null’ or contain missing values if a matching
record is present in eHARS.
1=Male who had sex with another male (MSM)
2=Injected illicit or non-prescription drugs (IDU)
3=Had sex with someone with either 1 or 2 (above)
4=Had Sex with Someone of the Opposite Sex but May Not Have Known whether
HIV Infection was diagnosed in that Person, or Any of the Risk factors of Sex
Partners Described in Items 3 or 5
5=Had Sex with Someone of the Opposite Sex in whom HIV Infection was
Diagnosed after Having Any Risk Factor for HIV Infection in Items 6 (Receipt of
Clotting Factor for Coagulation Disorder),7 (Receipt of Blood Transfusion), or 8
(Receipt of Transplant or Artificial Insemination)
6=Received Clotting Factor Injection for Hemophilia or Another Coagulation
Disorder
7=Received Transfusion of Blood or Blood Components (e.g., Platelets)
8=Received a Transplant of Tissue or Organ or Artificial Insemination
9=Worked in a Health-Care or Clinical Laboratory Setting with Possible Exposure
to Human Blood or Other Body Fluids
10=Had Other Exposure to Human Blood or Body Fluids
11=No Risk Reported
63
Y
F1_HPVVaxadmin
SSuN Cycle 4 (Version 12.2)
Was the patient given HPV vaccination at this visit?
1= Yes
2= No, not indicated/refused
3= No, clinic does not administer/offer HPV vaccination
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null values are allowed if the information is
collected by the facility but (1) is unknown for this record or (2) there is not an
opportunity for a “no” response (radio button).
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Strategy A – Diagnosis Dataset
DE# OMB
64
Y
DE Name
F2_PatientID
Description_________________________________________________
Unique patient identification number assigned by site
Will be a secondary key for merging laboratory and case data; should correspond
to F1_Visdate. This data element MUST NOT be ‘null’ or contain missing values.
65
66
Y
Y
F2_Eventid
Unique visit identification
F2_Visdate
Will be a secondary key for merging laboratory and case data; should correspond
to F1_Visdate. This data element MUST NOT be ‘null’ or contain missing values.
Date of clinic visit
Will be a secondary key for merging laboratory and case data; should correspond
to F1_Visdate. This data element MUST NOT be ‘null’ or contain missing values.
67
Y
F2_DXCODE
SSuN Cycle 4 (Version 12.2)
Diagnosis Code
SY01=Syphilis, primary
SY02=Syphilis, secondary
SY03=Syphilis, early latent
SY04=Syphilis, late latent/Unknown
SY05=Syphilis, neurosyphilis
SY06=Syphilis, unspecified/other
GC01=Gonorrhea
CT01=Chlamydia
GW01=Genital Warts
HI01=HIV/AIDS
BV01=Bacterial vaginosis (BV)
TR01=Trichomoniasis
GH01=Genital Herpes
NU01=Nongonococcal Urethritis (NGU)
MC01=Muco-purulent cervicitis (MPC)
PI01=Pelvic Inflammatory Disease (PID)
EP01=Epididymitis
CC01=Chancroid
LV01=Lymphogranuloma venereum (LGV)
GI01=Granuloma Inguinale
CD01=Candidiasis
SC01=Scabies
PD01=Pediculosis
CS01=Contact to STD
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PG01=Pregnancy
NE01=Normal exam/diagnosis
Null values allowed if information is collected by the facility but unknown for this
record.
Strategy A – Laboratory Dataset
DE# OMB
68
Y
DE Name
F3_PatientID
Description_________________________________________________
Unique patient identification number assigned by site
Will be a secondary key for merging laboratory and case data; should correspond
to F1_Visdate. This data element MUST NOT be ‘null’ or contain missing values.
69
Y
F3_Eventid
Unique visit identification
Will be a secondary key for merging laboratory and case data; should correspond
to F1_Visdate. This data element MUST NOT be ‘null’ or contain missing values.
70
Y
F3_Visdate
Date of clinic visit
Will be a secondary key for merging laboratory and case data; should correspond
to F1_Visdate. This data element MUST NOT be ‘null’ or contain missing values.
71
P
F3_SpecColdate
Date of specimen collection for this laboratory observation
This data element MUST NOT be ‘null’ or contain missing values.
72
Y
F3_Condtested
What condition was the patient tested for?
1 = Syphilis
2 = Gonorrhea
3 = Chlamydia
4 = Chancroid
5 = Trichomoniasis
6 = HIV/AIDS
7 = Bacterial vaginosis
8 = Herpes
9= Mycoplasm genitalium
20 = Pregnancy
Although a null value is allowed, sites should make every attempt to make sure
the value is not a null value. A record for a lab condition not included in the list
above, should not be submitted.
SSuN Cycle 4 (Version 12.2)
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73
Y
F3_Anatsite
What anatomic site was tested?
1 = Urethral
2 = Vaginal/cervical
3 = Urine
4 = Rectal
5 = Pharynx
6 = Blood
8 = Other
9= Not captured
Although a null value is allowed, sites should make every attempt to make sure
the value is not a null value.
74
Y
F3_Test_Type
What type of test was used? (Will be expanded, recoded)
1=Culture
2=NAAT
3=Non-amplified nucleic acid test/DNA probe
4=Gram Stain
5=DFA
6=Rapid HIV
7=ELISA
8=Western blot (deprecated code, see 27, 28 below)
9=Pooled RNA
10=RPR
11=VDRL
12=FTA
13=TP-PA
14=MHA
15=Wet Mount/Clue Cell
16=PH
17=Other, not listed
18=Unknown
22=HIV-1 IA (EIA or Other)
23=HIV-1/2 IA (EIA or Other)
24=HIV-2 IA (EIA or Other)
25=HIV-1/2 Ag/Ab
26=HIV-1/2 Type-Differentiating Immunoassay
27=HIV-1 Western Blot
28=HIV-2 Western Blot
29=HIV-1 IFA
30=HIV-1 Culture
31=HIV-2 Culture
32=HIV-1 p24 Antigen
33=HIV-1 RNA/DNA NAAT (Qualitative)
SSuN Cycle 4 (Version 12.2)
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34=HIV-2 RNA/DNA NAAT (Qualitative)
35=HIV-1 RNA/DNA NAAT (Quantitative viral load)
36=HIV-2 RNA/DNA NAAT (Quantitative viral load)
37=CD4 T-lymphocytes
38=CD4 Percent
39=HIV-1 Genotype (PR Nucleotide Sequence)
40=HIV-1 Genotype (RT Nucleotide Sequence)
41=HIV-1 Genotype (PR/RT Nucleotide Sequence)
42=HIV-1 Genotype (IN Nucleotide Sequence)
43=HIV-1 Genotype (PR/RT/IN Nucleotide Sequence)
44=STARHS (BED)
45=STARHS (Vironostika-LS)
46=STARHS ( BIO-RAD AVIDITY)
47=STARHS (Other)
48=STARHS (Unknown)
49=Rapid (Retired)
50=HIV-1/2 Ag/Ab-Distinguishing Immunoassay
51=HIV-1 Genotype (EN Nucleotide Sequence)
52=HIV-1 Genotype (FI Nucleotide Sequence)
53=HIV-1/2 Ag/Ab and Type-Differentiating Immunoassay
54=HIV-1/2 Ag/Ab and Type-Differentiating IA - HIV-1 p24 Antigen Analyte
55=HIV-1/2 Ag/Ab and Type-Differentiating IA - HIV-1 Antibody Analyte
56=HIV-1/2 Ag/Ab and Type-Differentiating IA - HIV-2 Antibody Analyte
57=HIV-1/2 Type-Differentiating Immunoassay (Supplemental)
58=HIV-1/2 Type-Differentiating IA (Suppl) - HIV-1 Antibody Analyte
59=HIV-1/2 Type-Differentiating IA (Suppl) - HIV-2 Antibody Analyte
60=HIV-1 Genotype (Unspecified)
61=WB/IFA-Legacy
62=RIPA-Legacy
63=Latex Ag-Legacy
64=Peptide-Legacy
65=Rapid-Legacy
66=Iga-Legacy
67=IVAP-Legacy
68=Other HIV Antibody-Other-Legacy
69=Other HIV Antibody-Unspecified-Legacy
70=Viral Load-Other-Legacy
71=Viral Load-Unspecified-Legacy
72=HIV Detection/Antigen/Viral Load-Other-Legacy
73=HIV Detection/Antigen/Viral Load-Unspecified-Legacy
80=Pregnancy
88= Other
99=Not captured
SSuN Cycle 4 (Version 12.2)
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Although a null value is allowed, sites should make every attempt to make sure
the value is not a null value.
75
Y
F3_Qualres
What was the qualitative test result?
0 = Negative
1 = Positive
2 = Nonreactive
3 = Reactive
4 = Indeterminate
5= Weakly Reactive
6 = QNS/Contaminated/Unsaturated
8 = Other/pending
9=Not captured
Although a null value is allowed, sites should make every attempt to make sure
the value is not a null value.
76
P
F3_Quantres
Numeric - or Ratio (for RPR/VDRL, e.g. 1:2, 1:4, etc.)
77
P
F3_QuantUnits
Units for quantitative results:
1=Copies/mL
2=Log Copies/mL
3=Cells/Cubic mm
4=CD4%
5=Titer Ratio
6=Cycles/Time (rtPCR)
Strategy A – Treatment Dataset
DE# OMB
DE Name
Description_________________________________________________
78
Y
F4_PatientID
Unique patient identification number assigned by site
Will be a secondary key for merging treatment and case data; should correspond
to F1_PatientID. This data element MUST NOT be ‘null’ or contain missing values.
79
Y
F4_Eventid
Unique visit identification
Will be a secondary key for merging treatment and case data; should correspond
to F1_EventID. This data element MUST NOT be ‘null’ or contain missing values
80
Y
F4_Visdate
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Date of clinic visit
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Will be a secondary key for merging treatment and case data; should not be ‘null’
or contain missing values
81
P
F4_TxDate
Treatment Date
Date treatment dispensed or prescribed; should not be ‘null’ or contain missing
values
82
Y
F4_Medication
What medication was prescribed to the patient (brand name)?
10= Amoxicillin (Amoxil, Polymox, Trimox, Wymox)
11= Ampicillin (Omnipen, Polycillin, Polycillin-N, Principen, Totacillin)
20= Azithromycin (Zithromax)
21= Erythromycin base
22= Clindamycin (Cleocin)
23= Gentamicin (Garamycin, G-Mycin, Jenamicin)
30= Cefixime (Suprax)
31= Ceftizoxime (Cefizox)
32= Cefotaxime (Claforan)
33= Cefoxitin (Mefoxin)
34= Cefpodoxime (Vantin)
35= Ceftibuten (Cedax)
36= Cefdinir (omnicef)
37= Ceftriaxone (Rocephin)
38= Cefuroxime (Ceftin, Kefurox, Zinacef, Zinnat)
40= Ciprofloxacin (Cipro, Cipro XR, Ciprobay, Ciproxin)
41= Levofloxacin (Cravit, Levaquin)
42= Moxifloxacin (Avelox, Vigamox)
43= Ofloxacin (Floxin, Oxaldin, Tarivid)
44= Gemifloxacin (Factive)
50= Doxycycline (Doryx, Vibramycin)
60= Metronidazole (Flagyl, Helidac, Metizol, Metric 21, Neo-Metric, Noritate,
Novonidazol)
61= Tinidazole (Tindamax)
70= Truvada (Tenofovir/emtricitabine)
88= Other
Although a null value is allowed, sites should make every attempt to make sure
the value is not a null value.
83
Y
F4_Medication_Oth
If the patient received a medication other than what is listed above as
indicated by response option #88, please provide name of other medication (Free
text description of other medication)
84
Y
F4_Dosage
What was the dosage of the medication prescribed?
1= 100mg
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2= 125mg
3= 150mg
4= 200mg
5= 240mg
6= 250mg
7= 300mg
8= 320mg
9= 400mg
10= 500mg
11= 600mg
12= 750mg
13= 800mg
14= 1g
15= 2g
88= Other
99= Not captured
A response of 99 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null value allowed if dosage is unknown or
missing.
85
Y
F4_Number_doses
Total number of doses prescribed?
Null value allowed if (1) number of total doses is unknown or missing or (2) the
information is not captured or collected by the facility or is not provided to SSuN.
86
Y
F4_Dose_Freq
What is the frequency of doses?
1=one single dose
2= twice day
3= three times a day
4= four times a day
8= other
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null value allowed if frequency of doses is
unknown or missing.
87
Y
F4_Duration
What duration was the medication prescribed for?
1= 1 day
2= 3 days
3= 5 days
4= 7 days
5= 10 days
6= 14 days
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8= Other
9= Not captured
A response of 9 indicates the information is not captured or collected by the
facility or is not provided to SSuN. Null value allowed if duration of medication is
unknown or missing.
Strategy A – Facility Reference Dataset
DE# OMB
DE Name
Description_________________________________________________
88
Y
F5_Facility_ID
Unique facility identifier
This ID should be supplied by the site and is a unique facility identifier from
underlying surveillance systems or may be generated specifically for SSuN.
Regardless of source, this ID must be unique and allow for longitudinal tracking
of the facility. This data element MUST NOT be ‘null’ or contain missing values.
89
Y
F5_SiteID
Unique site code
BA=Baltimore
CA=California
FL=Florida
MA=Massachusetts
MN=Minnesota
MC=Multnomah county
NY=New York City
PH=Philadelphia
SF=San Francisco
WA= Washington
VA=Virginia (Cycle II)
AL=Alabama (Cycle II)
CO=Colorado (Cycle II)
CH=Chicago (Cycle II)
CB= Columbus (Cycle IV)
UT = Utah (Cycle IV)
IN= Indiana (Cycle IV)
This data element MUST NOT be ‘null’ or contain missing values.
90
Y
F5_Facility_name
What is the name of the facility?
91
Y
F5_Facility_type
What is the facility type?
1= STD clinic
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88= Other
92
Y
F5_FQHC
Is this facility a FQHC?
1= Yes
2= No
93
Y
F5_Facility_Address
What is the physical street address of the facility?
94
Y
F5_Facility_City
In what city is the facility located?
FIPS code, example: 3290 (City of SF)
95
Y
F5_Facility_State
In what state is the facility located?
FIPS code
96
Y
F5_Facility_Zip
Zip code for the facility (9-digit ZIP code of facility)
97
Y
F5_Point_contact
Point of contact at facility
98
Y
F5_EPT
Does the facility have written policies governing EPT?
1= Yes
2= No
3= facility does not employ EPT
99
P
F5_PrEP
Does the facility have written policies governing referral or management of
PrEP?
1= Yes
2= No
3= facility does not refer to or manage PrEP
100
P
F5_PrEP_Rx
Does the facility prescribe PrEP?
1= Yes
2= No
3= facility does not prescribe PrEP
101
P
F5_PEP_Rx
Does the facility prescribe PEP?
1= Yes
2= No
3= facility does not prescribe PEP
102
P
F5_PrEP_Manage
Does the facility actively manage patients on PrEP?
1= Yes
2= No
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3= facility does not refer to or manage PrEP
103
Y
F5_HPV_vaccine
Does the facility have written policies governing HPV vaccination?
2= No
3= facility does not provide HPV vaccination
104
Y
F5_HIV_algorithm
Does the facility have written policies governing HIV testing?
1= Yes
2= No
3= facility does not provide HIV testing
105
Y
F5_Screening_CT
Does the facility have written policies governing chlamydia screening?
1= Yes
2= No
3= facility does not provide CT testing
106
Y
F5_Screening_GC
Does the facility have written policies governing gonorrhea screening?
1= Yes
2= No
3= facility does not provide GC testing
107
Y
F5_Billing
Does the facility bill for STD services?
1= Yes
2 = No
3= Other
108
Y
F5_Medical_record
Type of medical record system?
1= paper-based
2= electronic
3=combination
9= not sure
109
Y
F5_Insurance
Is the facility in an insurance network?
1=Yes
2=No
SSuN Cycle 4 (Version 12.2)
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Strategy A – Clinic Survey Dataset
DE# OMB
DE Name
Description_________________________________________________
TBD
Strategy A – LGV Specimen Dataset
DE# OMB
414
415
416
DE Name
Y
Y
P
LGV1_EventID
LGV1_PatientID
LGV1_SecimenID
Description_________________________________________________
Event ID from Facility Visit File
Patient ID from Facility Visit File
Specimen ID - locally assigned, unique specimen tracking ID
Strategy B – Case Dataset
DE# OMB
164
Y
DE Name
P1_SiteID
Description
SSuN Site ID
This 2 character code primarily identifies sites funded under SSuN Cycle 2 & 3 and
will include additional sites as required for Cycle 4. This data element MUST NOT be
‘null’ or contain missing values.
BA=Baltimore (Cycle II, Cycle III, Cycle IV)
CB=Columbus (Cycle IV)
CA=California (Cycle II, Cycle III, Cycle IV)
FL=Florida (Cycle III & Cycle IV)
IN=Indiana (Cycle IV)
MC=Multnomah County (Cycle III &Cycle IV)
NY=New York City (Cycle II, Cycle III, Cycle IV)
PH=Philadelphia (Cycle II, Cycle III, Cycle IV)
SF=San Francisco (Cycle II, Cycle III, Cycle IV)
WA= Washington (Cycle II, Cycle III, Cycle IV)
UT=UTAH (Cycle IV)
LA=Louisana (Cycle II)
VA=Virginia (Cycle II)
AL=Alabama (Cycle II)
CO=Colorado (Cycle II)
CH=Chicago (Cycle II)
MA=Massachusetts (Cycle III)
MN=Minnesota (Cycle III)
SSuN Cycle 4 (Version 12.2)
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165
Y
P1_EventID
Site generated unique event identifier
This record ID should be supplied by the site and may be an event or report identifier
from underlying surveillance system. Regardless of source, this ID must be unique
for each confirmed case report. This data element MUST NOT be ‘null’ or contain
missing values.
166
Y
P1_PatientID
Site generated ID allows for longitudinal tracking of unique persons
This ID should be supplied by the site and may be a unique patient identifier from
underlying surveillance systems or may be generated specifically for SSuN from
identifying information provided through case reporting. Regardless of source, this
ID must be unique and allow for longitudinal tracking of persons reported with
multiple episodes of disease. This data element MUST NOT be ‘null’ or contain
missing values.
167
Y
P1_RecRepDte
Earliest date this specific disease event/report received at health department?
This date should reflect the earliest information available to the health department
regarding the case. This date should include laboratory records received if lab
results were reported prior to receipt of a provider case report. This data element
MUST NOT be ‘null’ or contain missing values. This should be coded as a ‘SAS’
numeric date.
168
Y
P1_DxDte
What is the diagnosis date for the current episode of disease (may be date of
provider visit, specimen collection date, laboratory report date or other suitable
proxy)
This data element should not be ‘null’ or contain missing values. This should be
coded as a ‘SAS’ numeric date.
169
Y
P1_DxCode
Diagnosis
This data element should not be ‘null’ or contain missing values.
10273=Chancroid
10274=Chlamydia
10280=Gonorrhea
10311=Syphilis, primary
10312=Syphilis, secondary
10313=Syphilis, early non-primary non-secondary
10320=Syphilis, unknown duration or late
170
Y
P1_RandSamp
SSuN Cycle 4 (Version 12.2)
Is this record/case selected in the random sample?
This data element MUST NOT be ‘null’ or contain missing values.
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. = Not Sampled
0=Not in random sample
1=In random sample
171
Y
P1_SampDte
Date record/case sampled by jurisdiction
For jurisdiction deploying a batch process for record sampling, this should be the
actual date that the batch was sampled. For jurisdictions deploying real-time
sampling of cases through their surveillance system, this date should match the
report date (or date case status was confirmed if appropriate). This data element
should not be ‘null’ or contain missing values. This should be coded as a ‘SAS’
numeric date.
172
Y
P1_RecSx
Was lab or provider report how case was initially reported to the health
department?
This data element is intended to capture the source of the initial case notification to
the health department. If the grantee is not able to reliably capture this
information for a specific case, this must be documented by entering a value of ‘3’
for that case record. This data element should not be ‘null’ or contain missing
values.
0=Laboratory report, electronic
1=Laboratory report, paper
2=Provider report, electronic or paper
3=Report source not captured by surveillance system
173
Y
P1_PrevPtx
Is patient previously known to HD from infectious disease reporting records (TB,
HIV, STDs, Hep)?
This data element is designed to capture whether this patient is known to the HD
from a previous case report. This data element should not be ‘null’ or contain
missing values. If a match with previous patients is not done, please code as a new
patient. If a subsequent match is performed and patient found to be previously
reported, the value should be changed accordingly.
0=New Patient, not previously reported
1=Patient previously reported
174
Y
P1_InitSx
If patient previously reported, what is the registry/source of earliest report for this
PATIENT?
0=STD Registry
1=HIV Registry
2=Viral Hepatitis Registry
3=Other Disease Registry
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4=Unknown
175
Y
P1_HregMatch
Was eHARS registry match done for this patient?
This data element may be initially coded as ‘2’ if the grantee conducts a periodic
batch match with their HIV registry and the case is reported before that batch is
processed. This information can be updated in the SSuN record in the next data
transmission following the match. This data element should not be ‘null’ or contain
missing values.
1=Yes
2=No
176
Y
P1_HregMatchStat
Did this patient match a registry entry in eHARS?
This data element may be initially coded as ‘3’ if the grantee conducts a periodic
batch match with their HIV registry and the case is reported before that batch is
processed. This information can be updated in the SSuN record in the next data
transmission following the match. This data element should not be ‘null’ or contain
missing values.
1=Matching Record Found
2=No Matching Record
3=Match Not Performed
177
Y
P1_HregID
Unique record number from HIV registry (such as stateno from eHARS).
This data element should not be ‘null’ or contain missing values if a matching record
is present in eHARS.
178
Y
P1_HDXMOYR
What is this patient's earliest indication of HIV positive result?
This information can be obtained from the eHARS person table (HIVPMOYR). If
eHARS match found. This should be coded as character data (“MM/YY”) with
missing information as “../..” or “../YY”
179
Y
P1_EXPMOD
Exposure (HIV transmission) mode from HIV registry.
This data element should not be ‘null’ or contain missing values if a matching record
is present in eHARS.
1=Male who had sex with another male (MSM)
2=Injected illicit or non-prescription drugs (IDU)
3=Had sex with someone with either 1 or 2 (above)
4=Had Sex with Someone of the Opposite Sex but May Not Have Known whether
HIV Infection was
Diagnosed in that Person, or Any of the Risk factors of Sex Partners Described in
Items 3 or 5
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5=Had Sex with Someone of the Opposite Sex in whom HIV Infection was Diagnosed
after Having Any Risk Factor for HIV Infection in Items 6 (Receipt of Clotting Factor
for Coagulation Disorder), 7 (Receipt of Blood Transfusion), or 8 (Receipt of
Transplant or Artificial Insemination)
6=Received Clotting Factor Injection for Hemophilia or Another Coagulation
Disorder
7=Received Transfusion of Blood or Blood Components (e.g., Platelets)
8=Received a Transplant of Tissue or Organ or Artificial Insemination
9=Worked in a Health-Care or Clinical Laboratory Setting with Possible Exposure to
Human Blood or Other Body Fluids
10=Had Other Exposure to Human Blood or Body Fluids
11=No Risk Reported
180
Y
P1_Othno
Additional registry number
If this patient also has a record in other/ancillary disease registries. This is primarily
for local use in matching patient records to update missing information.
181
Y
P1_Othsx
Additional registry source
If this patient also has a record in other/ancillary disease registries and P1_Othno is
not blank, this element should be populated with the source.
0=STD Registry
1=HIV Registry (deprecated)
2=Viral Hepatitis Registry
3=Other Disease Registry
4=Unknown
182
Y
P1_PrevDx
Most recent previous diagnosis (if applicable; could include hep, TB or HIV)
If this patient also has a record in other/ancillary disease registries as indicated
above, indicate the diagnosis documented by that record. Should be ‘Null’ if no
previous diagnosis is confirmed.
10311=Syphilis, primary
10312=Syphilis, secondary
10313=Syphilis, early non-primary non-secondary
10320=Syphilis, unknown duration or late
10280=Gonorrhea
10274=Chlamydia
10100=Hepatitis B, acute
10105=Hepatitis B, chronic
20001=Hepatitis C
10562=HIV infection (non-AIDS)
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10560=AIDS
10307=Nongonococcal Urethritis (NGU)
10308=Muco-purulent cervicitis (MPC)
10309=Pelvic Inflammatory Disease (PID)
10273=Chancroid
10306=Lymphogranuloma venereum (LGV)
10276=Granuloma Inguinale
20002=TB
20003=Other
183
Y
P1_PrevDxDte
Date of most recent previous diagnosis documented above.
Should not be null if P1_PrevDx is not null.
184
Y
P1_PrevGCDx
Has the patient been previously diagnosed and reported with GC?
1=Yes
2=No
3=Registry records not searched
185
Y
P1_PrevGCDxDte
Date of most recent previous diagnosis of GC documented above.
Should not be null if P1_PrevGCDx = 1. This should be coded as a ‘SAS’ numeric date.
186
P
P1_ConcurCTDx
Was this patient diagnosed with CT at the same time as their current GC diagnoses?
1=Yes, tested and found to be CT positive
2=No, tested and found to be CT negative
3=No, patient not tested for CT/No CT information available
187
Y
P1_CaseDup
Is this record/case a duplicate report, new report or was duplicate status not
determined?
The grantee should document if an initial case report was subsequently found to be
a duplicate of an existing case – the record should be retained in the SSuN dataset
and coded as a duplicate (‘1’)? If the jurisdiction receives a report that they know to
be a duplicate at the time of report, the record can be omitted from the SSuN
datasets and not sampled for enhanced investigation. This data element should not
be ‘null’ or contain missing values.
0=New Case
1=Duplicate Case (previously reported <30 days)
9=Unknown, site surveillance system does not capture
SSuN Cycle 4 (Version 12.2)
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188
Y
P1_FacilityID
Site generated facility ID. Each reporting provider/facility must have a unique ID.
This is a primary key for linking the provider type and other provider information to
the case record. Historically, the majority of cases in any grantee’s jurisdictions will
be reported from known providers, but for cases reported from entirely new or
unknown providers, this field should be populated with that facility’s new number
and be included in the next update of the provider reference file. This data element
should not be ‘null’ or contain missing values.
189
Y
P1_Dispo
What is the status of the internal health department look-back investigation
(Includes HIV and other disease registry matching)?
The investigation referred to for this data element includes the search of existing
health department records, matching and merging with electronic or other
laboratory data, eHARS match and other disease registries. At initial report, cases
may be coded as ‘10’. This should be updated as appropriate. Cases listed as
"pending" should be updated within 60 days and this information updated in the
next SSuN data transmission. This data element should not be ‘null’ or contain
missing values. Jurisdictions may choose to initiate provider investigations on all
reported cases, regardless of whether they fall into the random sample, or may
elect to initiate investigations on only those records in the random sample.
0=Investigation complete: record referred to provider investigation
1=Investigation complete: no further action, record determined to be a duplicate of
existibng case
2=Investigation complete: no further action, case determined to reside OOJ
3=Investigation complete: no further action, case not in Sample
4=Investigation complete: no further action, case not eligible for SSuN
10=Investigation not complete: investigation pending (May be default value)
11=Investigation not complete: no further action, insufficient contact/provider
information
22=Investigation not complete: other reason
190
Y
P1_Referral1
Is this record/case referred for provider investigation?
This indicates whether the record has been referred to provider investigation. If
provider is not contacted, surveyed or otherwise followed up with to supply any
additional case-specific information, code as ‘1’. This data element should not be
‘null’ or contain missing values.
0=Referred to Provider Investigation
1=Not Referred to Provider Investigation
2=Referral Pending
191
Y
P1_PtxSex
SSuN Cycle 4 (Version 12.2)
Current sex of the patient as indicated on initial health department report?
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This data element should not be ‘null’ or contain missing values.
1=Male
2=Female
9=Unknown
192
P
P1_PtxGendID
Gender Identity of the patient as indicated on initial health department report.
1=Male-to-Female Transgender
2=Female-to-Male Transgender
3=Transgender, not specified
4=CIS Gender (Male or Female, NOT transgendered)
9=Gender Identity not documented
193
Y
P1_PtxRace_White
White Race
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Yes
2=No
3=Unknown
4=Refused
194
Y
P1_PtxRace_Black
Black Race
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Yes
2=No
3=Unknown
4=Refused
195
Y
P1_PtxRace_AIAN
American Indian/Alaska Native Race
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Yes
SSuN Cycle 4 (Version 12.2)
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2=No
3=Unknown
4=Refused
196
Y
P1_PtxRace_Asian
Asian Race
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Yes
2=No
3=Unknown
4=Refused
197
Y
P1_PtxRace_NHOPI
Native Hawaiian/Other Pacific Islander Race
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Yes
2=No
3=Unknown
4=Refused
198
Y
P1_PtxRace_Other
Other Race
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Yes
2=No
3=Unknown
4=Refused
199
Y
P1_PtxRace_UNK
SSuN Cycle 4 (Version 12.2)
Is all information on race and Hispanic ethnicity missing from initial
If additional/supplemental information is received on race and ethnicity of patient
but this information was missing from the initial report to the health department,
please leave this data element coded as ‘1’ and capture the source of supplemental
information below.
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1=Yes
2=No
200
Y
P1_PtxRaceSource
What is the source of the final race information of record as ascertained for this
patient?
For grantees able to distinguish the source of information for race, please indicate
as appropriate. For grantees NOT able to distinguish the source of race data at all,
code as ‘6’. If race information is missing/unknown from all sources, code as ‘5’.
1=Patient Self-Report
2=Provider Case Report
3=Laboratory Report
4=Previous Registry Record
5=No Information Available from Any Source
6=Source not Identifiable
201
Y
P1_PtxHisp
Patient Hispanic ethnicity
Information from case/lab reports to the health department only. Patient self-report
from interviews should be captured in interview variables. If additional information
from any source (other than patient report) is received, these data may be updated
as required by underlying surveillance system.
1=Hispanic
2=Non-Hispanic
3=Unknown
4=Refused
202
Y
P1_PtxHISPSource
What is the source of the final Hispanic ethnicity information
For grantees able to distinguish the source of information for Hispanic ethnicity,
please indicate as appropriate. For grantees NOT able to distinguish the source of
Hispanic ethnicity data at all, code as ‘6’. If information is missing/unknown from
all sources, code as ‘5’.
1=Patient Self-Report
2=Provider Case Report
3=Laboratory Report
4=Previous Registry Record
5=No Information Available from Any Source
6=Source not Identifiable
203
Y
P1_PtxAGE
SSuN Cycle 4 (Version 12.2)
Age of patient from initial reporting record/document .
If age information is missing/unknown from all sources, use null value.
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204
Y
P1_PtxAgeUnit
Age unit
If #32 is null, use null value for this data element (‘.’)
1=Years
2=Months
205
Y
P1_PtxCountyres
County of patient residence
If information is missing/unknown, code to null value ( ‘.’)
206
Y
P1_PtxCTract
Census Tract of patient residence
If information is missing/unknown, code to null value (‘.’)
207
Y
P1_PtxAddrStat
Was patient street address present and complete in initial reporting documents?
This data element should not be ‘null’ or contain missing values.
1=Street Address Known
2=Street Address Missing
3=Street Address Incomplete
208
Y
P1_GCAccuracy
What is the basis of census tract assignment (XY coordinates, street segment,
centroid, etc.)
This data element should not be ‘null’ or contain missing values.
1=Close (based on direct street segment, parcel, or lon/lat match.)
2=Approximate (modification of address required to match to to street segment)
3=Very approximate (based only on zip or city centroid)
4=Not-geocodable (insufficient data to geocode, PO Box, General Delivery)
9=Missing (no address available)
209
Y
P1_SiteUrine
Urine 'site' of infection
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
210
Y
P1_SiteVagCerv
Vaginal or cervical site of infection in women
If information is missing/unknown, code as ‘3’
1=Yes
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2=No
3=Unknown
211
Y
P1_SiteUreth
Urethral site of infection - only if this is specifically indicated.
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
212
Y
P1_SiteRect
Rectal site of infection
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
213
Y
P1_SitePhar
Pharyngeal site of infection
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
214
Y
P1_SiteEye
Ocular site of infection
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
215
Y
P1_SiteSera
Blood or sera infection
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
216
Y
P1_SiteJoint
SSuN Cycle 4 (Version 12.2)
Joint or synovial fluid infection
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
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217
Y
P1_SiteOTH
Site of infection, not specified above
If information is missing/unknown, code as ‘3’
1=Yes
2=No
3=Unknown
218
Y
P1_SiteUNK
All site of infection information missing for this case - use only if no other
information is available.
If the answer to any one of 40-48 above is ‘1’ or ‘2’ then this data element should be
coded ‘2’. If all data elements 40-48 are coded as ‘3’ then code this data element as
‘1’.
1=Yes
2=No
219
Y
P2_ProvID
Unique facility/provider ID
This data element MUST NOT be ‘null’ or contain missing values for cases in the
random sample. SHOULD NOT be null for all other cases (collaborators requested to
include this information for all gonorrhea case records – this can be accomplished
with a default coding of P2_ProvID= P1_FacilityID.
220
Y
P2_ProvCO
County FIPS code for provider/facility physical location
This should be coded as the 3-digit FIPS code for the county.
221
Y
P2_ProvZIP
Facility/provider physical location 5-digit ZIP
222
Y
P2_ProvCHC
Is facility/provider a Community Health Center (CHC)?
Community Health Centers are not-for-profit primary care organizations governed
by a community board and whose primary mission is to provide medical services to
traditionally under-served populations. The primary way of determining CHC status
is by self-identification (though some put it in their name). The National Association
of Community Health Centers (NACHC) does maintain member lists as well. Nonprofit and community board governance are the key features.
1=Yes
2=No
3=Unknown/Missing
223
Y
P2_ProvFQHC
SSuN Cycle 4 (Version 12.2)
Is facility/provider a Federally Qualified Health Center (FQHC)?
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Federally qualified health centers (FQHCs) include all organizations receiving grants
under Section 330 of the Public Health Service Act (PHS). These are a matter of
public record and lists are available from HRSA
1=Yes
2=No
3=Unknown/Missing
224
Y
P2_ProvPTXvisitDte
Date of patient initial visit for this issue, can be supplied/filled in from initial case
report.
This should be formatted as a ‘SAS’ numeric date.
225
Y
P2_ProvClinType
What was the category of provider examining/treating this patient?
1=MD
2=RN
3=PA
4=ARNP
5=LPN
6=Other
7=Unknown/Not Ascertained
226
Y
P2_ProvPTX_GenderSP
Provider documented gender of sex partners
1=Males only
2=Females only
3=Both Males and Females
4=Not Documented
227
Y
P2_ProvPTX_Insure
Insurance status of patient from provider's records
1=Yes, Insured
2=No, Not Insured
3=Unknown/Missing
228
Y
P2_Urethritis
Was urethritis found on exam
Missing/unknown information code as null (‘.’).
1=Yes
2=No
229
Y
P2_Proctitis
SSuN Cycle 4 (Version 12.2)
Was proctitis found on exam
Missing/unknown information code as null (‘.’).
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1=Yes
2=No
230
Y
P2_Epididymitis
Was epididymitis found on exam
Missing/unknown information code as null (‘.’).
1=Yes
2=No
231
Y
P2_PID
Was PID diagnosed.
Missing/unknown information code as null (‘.’).
1=Yes
2=No
232
Y
P2_Discharge
Was discharge found on exam
Missing/unknown information code as null (‘.’).
1=Yes
2=No
233
Y
P2_OtherFinding
Were there other STD-related findings on exam
Missing/unknown information code as null (‘.’).
1=Yes
2=No
234
Y
P2_NoFinding
Were there NO findings on exam
Missing/unknown information code as null (‘.’).
1=Yes
2=No
235
Y
P2_ProvScrnUreth
Was patient screened/tested for infection at urethral site
1=Yes
2=No
3=Unknown
4=Refused
236
Y
P2_ProvScrnVagCerv
SSuN Cycle 4 (Version 12.2)
Was patient screened/tested for infection at vaginal/cervical site
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1=Yes
2=No
3=Unknown
4=Refused
237
Y
P2_ProvScrnAnal
Was patient screened/tested for infection at anorectal site
1=Yes
2=No
3=Unknown
4=Refused
238
Y
P2_ProvScrnPhar
Was patient screened/tested for infection at pharyngeal site
1=Yes
2=No
3=Unknown
4=Refused
239
Y
P2_ProvScrnHIV
Was patient screened/tested for HIV infection at time of visit
1=Yes
2=No
3=Unknown
4=Refused
249
Y
P2_ProvPTX_PDPT
Were any medications/prescriptions provided for patient's partner(s)?
Missing/unknown information code as null (‘.’).
1=Yes
2=No
250
Y
P2_ProvPTX_HIBC
Was patient counseled to prevent transmission/reinfection?
Missing/unknown information code as null (‘.’).
1=Yes
2=No
251
Y
P2_ProvPTX_Refer
Was patient referred to HD (or other) for partner services?
Missing/unknown information code as null (‘.’).
1=Yes
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2=No
252
Y
P2_ProvPTX_PrepRefer
Was patient referred for PrEP?
Missing/unknown information code as null (‘.’).
1=Yes
2=No
Strategy B – Treatment Dataset
240
Y
P2_PR_EventID
Primary key for merging treatment records with case file, should be the same as
P1_EventID
Must not be missing or null.
241
Y
P2_PR_ProvPTX_TxDte
Treatment date (or date of administration, date prescription given)
This should be coded as a ‘SAS’ numeric date. Missing/unknown information code as
null (‘.’).
242
P
P2_PR_DrugName
What drug was patient treated with?
01=Penicillin G (benzathine, aqueous procaine, or aqueous crystalline)
02=Probenacid
10= Amoxicillin (Amoxil, Polymox, Trimox, Wymox)
11= Ampicillin (Omnipen, Polycillin, Polycillin-N, Principen, Totacillin)
20= Azithromycin (Zithromax)
21= Erythromycin base
22= Clindamycin (Cleocin)
23= Gentamicin (Garamycin, G-Mycin, Jenamicin)
30= Cefixime (Suprax)
31= Ceftizoxime (Cefizox)
32= Cefotaxime (Claforan)
33= Cefoxitin (Mefoxin)
34= Cefpodoxime (Vantin)
35= Ceftibuten (Cedax)
36= Cefdinir (omnicef)
37= Ceftriaxone (Rocephin)
38= Cefuroxime (Ceftin, Kefurox, Zinacef, Zinnat)
40= Ciprofloxacin (Cipro, Cipro XR, Ciprobay, Ciproxin)
41= Levofloxacin (Cravit, Levaquin)
42= Moxifloxacin (Avelox, Vigamox)
43= Ofloxacin (Floxin, Oxaldin, Tarivid)
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44= Gemifloxacin (Factive)
50= Doxycycline (Doryx, Vibramycin)
60= Metronidazole (Flagyl, Helidac, Metizol, Metric 21, Neo-Metric, Noritate,
Novonidazol)
61= Tinidazole (Tindamax)
70= Truvada (Tenofovir/emtricitabine)
88= Other (provide text in P2_PR_OthMedTXT)
Must not be missing or null.
243
P
P2_PR_OthMedTXT
Other medication if value of 88 selected for P2_PR_DrugName
244
P
P2_PR_Dosage
Dosage - numeric
Missing/unknown information code as null (‘.’).
245
P
P2_PR_Dose_Units
Dosage units
01-Miligrams (mg)
02-Grams (g)
03-Units
04-Units/Kilogram
05-Million Units
06-Million Units/Kilogram
07-Milliliters (ml)
246
P
P2_PR_Method
Method of administration
01=PO - oral dosing
02=IM - intramuscular
03=IV - intravenous/infusion
04=Other
05=Unknown
Missing/unknown information code as null (‘.’).
247
P
P2_PR_Number
Number of doses/day
0=Single dose, STAT
Numeric value for all other
Missing/unknown information code as null (‘.’).
248
P
P2_PR_Duration_Number
SSuN Cycle 4 (Version 12.2)
Days duration or frequency of doses
Missing/unknown information code as null (‘.’).
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Strategy B – Patient Interview Data
253
1
Y
P3_IDX_ID
Interviewer/Investigator ID
This is a locally assigned ID to uniquely identify the person conducting patient
interview. This data element should not be ‘null’ or contain missing values for
interviewed cases.
254
2
Y
P3_PatientID
Unique identifier for person/patient
Will be a secondary key for merging data; should correspond to P1_PatientID. This
data element should not be ‘null’ or contain missing values for interviewed cases.
255
3
Y
P3_EventID
Unique identifier for record
Will be a primary key for merging data; should correspond to P1_EventID. This data
element should not be ‘null’ or contain missing values for interviewed cases.
256
4
Y
P3_IDX_CADate1
Contact attempt date 1
This data element should not be ‘null’ or contain missing values for interviewed
cases.
257
5
Y
P3_IDX_CAout1
Contact attempt outcome 1
This data element should not be ‘null’ or contain missing values for interviewed
cases.
0=Answer/Partial or Complete Interview Obtained
1=No Answer/No Message
2=No Answer/Message Left
3=Answer/Hang up
4=Answer/Refusal
5=Answer/Reschedule DIS call-back
6=Answer/Reschedule Patient Callback
7=Number out of service
8=Other
258
6
Y
P3_IDX_CADate2
Contact attempt date 2
This should be coded as a ‘SAS’ numeric date.
259
7
Y
P3_IDX_CAout2
Contact attempt outcome 2
0=Answer/Partial or Complete Interview Obtained
1=No Answer/No Message
2=No Answer/Message Left
3=Answer/Hang up
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4=Answer/Refusal
5=Answer/Reschedule DIS call-back
6=Answer/Reschedule Patient Callback
7=Number out of service
8=Other
260
8
Y
P3_IDX_CADate3
Contact attempt date 3
This should be coded as a ‘SAS’ numeric date.
261
9
Y
P3_IDX_CAout3
Contact attempt outcome 3
0=Answer/Partial or Complete Interview Obtained
1=No Answer/No Message
2=No Answer/Message Left
3=Answer/Hang up
4=Answer/Refusal
5=Answer/Reschedule DIS call-back
6=Answer/Reschedule Patient Callback
7=Number out of service
8=Other
262
10
Y
P3_IDX_CADate4
Contact attempt date 4
This should be coded as a ‘SAS’ numeric date.
263
11
Y
P3_IDX_CAout4
Contact attempt outcome 4
0=Answer/Partial or Complete Interview Obtained
1=No Answer/No Message
2=No Answer/Message Left
3=Answer/Hang up
4=Answer/Refusal
5=Answer/Reschedule DIS call-back
6=Answer/Reschedule Patient Callback
7=Number out of service
8=Other
264
12
Y
P3_IDX_Ixdate
Interview/Disposition Date
This should be coded as a ‘SAS’ numeric date.
265
13
Y
P3_IDX_Dispo
Patient Investigation/Interview Disposition
Should not be ‘null’ for cases included in random sample.
0=Investigation complete: patient contacted, interview
SSuN Cycle 4 (Version 12.2)
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1=Investigation complete: patient contacted, partial interview
10=Investigation not complete: P3 investigation pending
11=Investigation not complete: patient contacted, refused
12=Investigation not complete: patient contacted, unable to
22=Investigation not complete: patient did not respond to at
33=Investigation not complete: patient contact not initiated
44=Investigation not complete: patient contact not initiated
55=Investigation not complete: >60 days from diagnosis
66=Investigation not complete: case determined to be OOJ
77=Investigation not complete: insufficient contact information
88=Investigation not complete: provider refused patient contact
99=Investigation not complete: administrative closure/other
266
14
Y
P3_PTX_age
What is your age?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
888=Refused
267
15
Y
P3_PTX_sex
What gender or sex do you consider yourself to be?
Gender Identity
1= CIS Male
2=CIS Female
3=Male-to-Female TG
4=Female-to-Male TG
5=TG Unspecified
6=Queer, Gender Non-binary
7=Other
8=Refused
268
16
Y
P3_PTX_HispEthnic
Do you consider yourself to be Hispanic or Latino/a?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Unknown
4=Refused
269
16.1
P
P3_PTX_HISPOrgin
Do you consider yourself to be…?
1=Mexican, Mexican Am., Chicano/a, Latino/a
2=Puerto Rican
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3=Cuban
4=Central American (Guatemalan, Honduran, Nicaraguan, El Salvadoran)
5=Other Hispanic Origin
6=Unknown
9=Refused
270
16.2
271
17
P
P3_PTX_HISPTXT
Other Hispanic Origin
Y
P3_PTX_White
Patient reported White race
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Unknown
4=Refused
272
18
Y
P3_PTX_Black
Patient reported Black race
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Unknown
4=Refused
273
19
Y
P3_PTX_AIAN
Patient reported AIAN race
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Unknown
4=Refused
274
19.1
275
20
P
P3_PTX_AIAN_TXT
Tribal Affiliation ____________________________________
Y
P3_PTX_Asian
Patient reported Asian race
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
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3=Unknown
4=Refused
276
20.1
P
P3_PTX_AsianOrigin
Asian Origin
1=Asian Indian (India)
2 =Japanese
3=Chinese/Taiwanese
4=Korean
5=Filipona/o
6=Southeast Asian (Vietnamese, Thai, Cambodian, Burmese)
7=Indonesian
8=West Asians (Middle East)
9=Other/Unk Asian
10=Refused
277
21
Y
P3_PTX_NHOPI
Patient reported NHOPI race
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Unknown
4=Refused
278
21.1
P
P3_PTX_PIOrigin
(21) patient reported NHOPI origin
1=Native Hawaiian
2=Guamanian/Chamorro/Fijian/Chuukese/Carolinian
3=Samoan/Tokelauan/Tongan/Yapese
4=Niuean/Palauan/Pohnpeian
5=Kosraean/Marshallesse
6=Other Pacific Island
9=Refused
279
22
Y
P3_PTX_OTHrace
Patient reported other race
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Unknown
4=Refused
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280
22.1
Y
P3_PTX_OTHraceTxt
Patient-reported other race
281
23
Y
P3_PTX_RefRace
Patient refuses provision of all race information
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
282
23.1
P
P3_PTXNativity
Where were you born?
1=In the US
2=Outside the US
283
23.2
284
23.3
285
P
P3_PTXBirtState
Birth State
P
P3_PTXBirtCount
Birth County
Y
P3_PTX_Insure
Do you have any kind of health care coverage, including health insurance, prepaid
plans such as HMOs, or government plans such as Medicare, Indian Health
Services, the V.A. or Military?
24
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
286
25
Y
P3_PTX_InsType
What kind of healthcare insurance do you have?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Private healthcare insurance provided by my employer
2=Private healthcare insurance I pay for myself
3=Public healthcare insurance like Medicaid, Medicare, or a
4=Active or retired military or dependent plan like the V.A. or
5=Bureau of Indian Affairs/IHS/Urban Indian Health
7=Other
8=Don‘t know / Not sure
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9=Refused
287
25.1
288
Y
P3_PTX_OthInsSpecify
Other type of insurance (text)
Y
P3_PTX_PriCareDoc
Do you have one person you think of as your personal doctor or health care
provider?
26
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes, only one
2=More than one or facility
3=No
4=Don't Know /Not Sure
5=Refused
289
Y
P3_PTX_Hccost
27
Was there a time in the past 12 months when you needed to see a doctor but
could not because of cost?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
290
Y
P3_PTX_OOPE
28
When you went to see _______________ (mention provider, clinic or facility
name) when you were diagnosed with gonorrhea, did you need to pay anything
out-of-pocket at the time of your visit?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
291
Y
P3_PTX_SYMP1
28.1
Before you went to see _______________ (mention provider, clinic or facility
name) when you were diagnosed with gonorrhea, did you have any unusual
discharge or oozing from your (penis/vagina)?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
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2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
292
Y
P3_PTX_SYMP2
28.2
Before you went to see _______________ (mention provider, clinic or facility
name) did you notice any unexplained sores or bumps on your (penis/vagina)?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
293
Y
P3_PTX_SYMP3
28.3
Before you went to see _______________ (mention provider, clinic or facility
name) when you were diagnosed with gonorrhea, did you have any pain or burning
when you urinated?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
294
Y
P3_PTX_SYMP4
29
Did you go to the doctor that time because you were having symptoms or pains you
thought might be from an STD
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
295
Y
P3_PTX_Delay
30
How long did you have these symptoms or pains before you were able to see the
doctor?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=1 Day
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2=2 - 6 Days
3=1 - 2 weeks
4=More than 2 weeks
5=Don‘t know / Not sure / Don’t remember
6=Refused
296
Y
P3_PTX_ExpSTD
31
Before you went to the doctor that time, did any of your sex partners tell you that
you might have been exposed to an STD?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
297
Y
P3_PTX_reasA
32
Reason for going to specific doctor: regular doctor: Because this is your
usual/regular doctor.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
298
33
Y
P3_PTX_reasB
Reason for going to doctor: Because you could get seen for free?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
299
34
Y
P3_PTX_reasC
Reason for going to doctor: Because they take your insurance?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
300
Y
P3_PTX_reasD
35
SSuN Cycle 4 (Version 12.2)
Reason for going to specific doctor: Because you felt more comfortable about your
privacy there?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
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1=Yes
2=No
301
36
Y
P3_PTX_reasE
Reason for going to specific doctor: Because you could get seen right away?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
302
Y
P3_PTX_reasF
37
Reason for going to specific doctor: Because you wanted to see an expert
specializing in STDs.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
303
Y
P3_PTX_reasI
38
Reason for going to specific doctor: Because this doctor is close to your house and
easy to get to.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
304
Y
P3_PTX_reasG
39
Reason for going to specific doctor: Because you were embarrassed and didn’t
want to go to your regular doctor.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
305
Y
P3_PTX_reasH
40
Reason for going to specific doctor: Because I didn’t want the insurance papers/info
sent to my home/parents.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
306
Y
P3_PTX_reasJ
SSuN Cycle 4 (Version 12.2)
Reason for going to specific doctor: Any other reason?
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This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
307
42
308
43
Y
P3_PTX_othReasonText
Other reason text.
Y
P3_PTX_refusreason
Refused all reasons
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
309
Y
P3_PTX_PartnerTest
44
Did the doctor, nurse or anyone else during that visit talk to you about the
importance of getting your sex partners examined and tested for STDs?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
310
Y
P3_PTX_TellParts
45
In the time since your visit, did you tell any of your sex partners they may need to
tested or treated for STDs?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
311
Y
P3_PTX_EPToffer
46
Did a doctor, nurse or someone at the health department offer to give you
medications or a prescription for you to give to any of your sex partner(s)?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
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4=Refused
312
Y
P3_PTX_EPTWHO
47
Who was it that offered you the additional medications or prescriptions? Was it
someone from your doctor’s office or someone from the health department?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=My doctor’s office
2=The health department
3=Someone else
4=Don‘t know / Not sure
5=Refused
313
Y
P3_PTX_EPTGET
48
Did you actually get the additional medications or prescriptions for your sex
partners?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
314
Y
P3_PTX_EPTMEDORRX
49
Did you get medicine to give to your partner? Or did you get prescriptions that your
partners needed to have filled at a pharmacy?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=I got additional medications
2=I got prescription(s)
3=Don‘t know / Not sure
315
Y
P3_PTX_EPTGAVE
50
Did you give the additional medications or prescriptions to at least one of your sex
partners?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
9=Refused
316
P
P3_PTX_EPTPARTTAKE
Do you think at least one of your sex partners took this medication?
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1=Yes, I think at least one of my partner(s) took this medicine
2=No, I do not think any of my partner(s) took these medicines
9=Refused
317
52
Y
P3_PTX_HIVtested
Did you get tested for HIV at that visit?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ (P3_IDX_Dispo) = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
318
53
Y
P3_PTX_HIVresult
What was the result of your HIV test at that visit?
This data element should not be ‘null’ or contain missing values if
P3_PTX_HIVtested=1.
1=Positive
2=Negative
3=Don't Know / Not Sure / did not get results
4=Refused
319
54
Y
P3_PTX_everHIVtst
Have you ever been tested for HIV?
May be ‘Null’ if P3_PTX_HIVtested=1. This data element should not be ‘null’ or
contain missing values for cases responding with 2, 3 or 4 to P3_PTX_HIVtested.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
320
Y
P3_PTX_whenHIVtest
When was your last HIV test? Just month and year is ok? (IF PATIENT UNABLE TO
RECALL, PROBE UNTIL APPROXIMATE RESPONSE ELICITED)
This should be character data ”MM/YYYY”, missing/REFUSED information
as”../YYYY” or “../….”
Y
P3_PTX_HIVeverResult
What was the result of that HIV test?
This data element should not be ‘null’ or contain missing values for cases
responding to P3_PTX_everHIVtst=1.
55
321
56
1=Positive
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2=Negative
3=Don't Know / Not Sure / did not get results
4=Refused
322
57
Y
P3_PTX_inHIVcare
When was your most recent visit to a doctor, nurse or other health
This data element should not be ‘null’ or contain missing values for cases
identifying as HIV positive (P3_PTX_HIVResult=1 or P3_PTX_HIVeverResult=1). This
should be entered as character data ”MM/YYYY”, missing/REFUSED information
as”../YYYY” or “../….”
323
58
Y
P3_PTX_ART
Are you taking antiretroviral medicines to treat your HIV infection?
This data element should not be ‘null’ or contain missing values for cases
identifying as HIV positive (P3_PTX_HIVResult=1 or P3_PTX_HIVeverResult=1). This
should be entered as character data ”MM/YYYY”, missing/REFUSED information
as”../YYYY” or “../….”
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
324
Y
P3_PTX_PrEP
58.1
When you were diagnosed with gonorrhea, did your health care provider or anyone
else discuss medications to help you prevent getting HIV? This is often called PrEP,
or pre-exposure prophylaxis.
This data element should be ‘null’ for patients reporting being HIV positive. This
data element should not be ‘null’ or contain missing values for patients identifying
as HIV negative or unknown HIV status.
1=Yes
2=No
3= Don‘t know / Not sure
4=Refused
325
58.2
Y
P3_PTX_PREP1
Did your health care provider offer to prescribe or give you
medications to help you prevent getting HIV?
This data element should not be ‘null’ or contain missing values if patient reports
PrEP.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
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326
Y
P3_PTX_PREP2
Did you fill a prescription or get medications to help you prevent getting HIV?
58.3
This data element should not be ‘null’ or contain missing values for those answering
“Yes” to P3_PTX_PrEP.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
327
58.4
Y
P3_PTX_PREP3
Are you currently taking daily medications to help you prevent
getting HIV (on PrEP)?
This data element should not be ‘null’ or contain missing values.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
328
59
Y
P3_PTX_Pregnant
Were you pregnant at the time you were told that you had gonorrhea?
This data element should not be ‘null’ or contain missing value for female cases
interviewed. May be null for partial interviews, must be null for male cases.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
329
Y
P3_PTX_GenderSP
60
During the past 12 months, have you had sex with only males, only females or
both?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo) = ‘1’, partial interview.
1=Males only
2=Females only
3=Both Males and Females
4=Unknown
9=refused
330
P
P3_PTX_TGSP
During the past 12 months, have you had sex with a transgender man or
transgender woman?
60.1
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1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
331
61
Y
P3_PTX_Sxorient
Do you consider yourself to be…
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo) = ‘1’, partial interview.
1=Heterosexual/Straight (not Gay or Lesbian)
2=Gay/Lesbian/Homosexual
3=Bisexual
4=Other/Don't Know
9=Refused
332
62
Y
P3_PTX_MaleSPL3MO
Thinking back to the 3 months before you were diagnosed with
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview. Probe for approximate
response or ‘best’ guess. Enter 0 to indicate ‘None’, 9999 to indicate “Refused”.
333
63
Y
P3_PTX_FemaleSPL3MO
Thinking back to the 3 months before you were diagnosed with
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview. May be ‘Null’ if
P3_IDX_Dispo = ‘1’, partial interview. Probe for approximate response or ‘best’
guess. Enter 0 to indicate ‘None’, 9999 to indicate “Refused”.
334
63.1
Y
P3_PTX_SPtreatOne
To the best of your knowledge, was your sex partner treated?
This data element is for patient reporting only a single sex partner.
1=Yes, definitely
2=Yes, probably
3=Don't Know / Not Sure
4=No, probably not
5=Refused
6=No need/no partners infected
335
Y
P3_PTX_SPtreatMult
63.2
To the best of your knowledge, would you say that all of your sex partners were
definitely treated, at least one of your partners was definitely treated, or that none
were treated?
This data element is for patients reporting multiple sex partners.
1=All definitely treated
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2=At least one definitely treated
3=At least one probably treated
4=Not sure
5=Probably none treated
6=Refused
7=No need/no partners infected
336
Y
P3_PTX_SexExch
64
During the past 12 months, have you given drugs or money in exchange for sex or
received drugs or money in exchange for sex? By sex we mean vaginal, oral, or
anal sex.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Don't Remember/ Not Sure
4=Refused
337
64.1
Y
P3_PTX_Opioid
In the past year, how often have you used prescription pain medications
other than as prescribed by a doctor?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if #107 (P3_IDX_Dispo) = ‘1’, partial interview.
1=Never
2=Once or Twice
3=Monthly
4=Weekly
5=Daily or Almost Daily
9=Refused
338
Y
P3_IVDU
In the past year, have you used any injection drugs such as heroin, cocaine or
meth?
64.2
1=Yes
2=No
3=Don’t Know/Can’t Remember
4=Refused
339
64.3
Y
P3_IVDU_HER
In the past year, did you inject heroin?
1=Yes
2=No
3=Don’t Know/Can’t Remember
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4=Refused
339.1 Y
64.4
P3_IVDU_COC
In the past year, did you inject cocaine/crack?
1=Yes
2=No
3=Don’t Know/Can’t Remember
4=Refused
339.2 Y
64.5
P3_IVDU_MTH
In the past year, did you inject Crystal Meth/Methamphetamine/Methadrone?
1=Yes
2=No
3=Don’t Know/Can’t Remember
4=Refused
339.3 Y
P3_IVDU_OXY
In the past year, did you inject Oxycodone/morphine/Fentanyl/Carfentanil/some
other opioid?
64.6
1=Yes
2=No
3=Don’t Know/Can’t Remember
4=Refused
339.4 Y
64.7
P3_IVDU_OTH
In the past year, did you inject other durgs not listed?
1=Yes
2=No
3=Don’t Know/Can’t Remember
4=Refused
340
64.8
Y
P3_IVDU_DR_TX
Other drug injected text.
341
65
Y
P3_PTX_LastSex
When was the last time you had sex?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=In last week
2=> 1 week but within last month
3=> 1 month, but within 2 months
4=> 2 months ago
5=Don't Know / Not sure
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9=Refused
342
Y
P3_PTX_GenderMRSP
66
Thinking back to the last time you had sex, was the person you had sex
with…(male/female)?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=Cis Male
2=Cis Female
3=Male-to-Female TG
4=Female-to-Male TG
5=TG Unknown or Unspecified
9=Unknown
343
Y
P3_PTX_AgeMRSP
Thinking back to the last person you had sex with, how old do you think that person
is? If you don’t know for sure, it’s OK to make your best guess.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
Y
P3_PTX_HISPMRSP
Would you say that person is Hispanic/Latino/a? If you don’t know for sure, it’s OK
to make your best guess.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
67
344
68
1=Yes, Hispanic
2=No, Not Hispanic
8=Unknown/Can't guess
9=Refused
345
Y
P3_PTX_RaceMRSP
69
Thinking back to the last person you had sex with, what race(s) would you say that
person is? If you don’t know for sure, it’s OK to make your best guess.
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=White
2=Black
3=AI/AN
4=ASIAN
5=NH/OPI
6=Multiple Races
7=Other race
8=Unknown/Can't guess
9=Refused
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346
Y
P3_PTX_MRSPHIV
70
Thinking back to the last person you had sex with, do you know if that person HIV
positive?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=Yes, I know that person is HIV positive
2=No, I know that person is HIV negative
3=Don't Know /Don't Remember/ Not Sure
4=Refused
347
Y
P3_PTX_SexAgainMRSP
71
Thinking back to the last person you had sex with; do you think you will have sex
with this person again?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=Yes
2=No
3=Don't Know /Maybe/ Not Sure
4=Refused
348
72
Y
P3_PTX_DIS_EPT
Did the interviewer/DIS provide EPT/PDPT to patient?
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=Yes
2=No
349
73
Y
P3_PTX_DIS_EPTnum
Number of partners EPT provided for
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
350
Y
P3_PTX_DIS_OtherPS
Did interviewer/DIS provide other partner services to patient (DIS referral?)
74
This data element should not be ‘null’ or contain missing values for interviewed
cases. May be ‘Null’ if P3_IDX_Dispo = ‘1’, partial interview.
1=Yes
2=No
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Strategy B – Laboratory Dataset
351
Y
P1_L1_EventID
Unique identifier for associated surveillance record
Will be a primary key for merging lab and case data; should correspond to
P1_EventID. This data element MUST NOT be ‘null’ or contain missing values.
352
Y
P1_L1_LabID
Unique identifier for laboratory performing testing
Site assigned; may be ID from other system or specifically created for SSuN. If
performing lab is not known, site should still create a lab record with a locally
defined ID corresponding to unknown lab that they will use throughout the SSuN
data collection period. This data element should not be ‘null’ or contain missing
values.
353
Y
P1_L1_Accession
Unique identifier (accession number) for laboratory record
Leave blank (null) if not available/ascertained
354
Y
P1_L1_PatientID
Unique identifier for person (allowing longitudinal tracking of persons)
Will be a secondary key for merging lab and case data; should correspond to
P1_PatientID. This data element MUST NOT be ‘null’ or contain missing values.
355
Y
P1_L1_CondTested
Specific condition/pathogen tested
This data element MUST NOT be ‘null’ or contain missing values.
1=Syphilis
2=Gonorrhea
3=Chlamydia
4=Genital Herpes
5=Trichomoniasis
6=HIV
7=Hep A
8=Hep B
9=Hep C
10=BV
11=Other
356
Y
P1_L1_SpecColDte
Specimen collection date - this is often used as a proxy for diagnosis
This data element should not be ‘null’ or contain missing values. This should be
coded as a ‘SAS’ numeric date.
357
Y
P1_L1_LabRepDte
This is the date that the performing lab reported the results to the
This should be coded as a ‘SAS’ numeric date.
358
Y
P1_L1_SecType
Type of specimen
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This data element should not be ‘null’ or contain missing values.
1=Exudate
2=Blood/sera
3=Synovial fluid
4=Urine
5=CSF
6=Tissue
7=Saliva
8=Other
9=Unknown
359
Y
P1_L1_AnatSite
This is the anatomic site from which the specimen was obtained and is important in
determining the anatomic site of infection.
This data element should not be ‘null’ or contain missing values.
1=Urethra
2=Vagina/cervix
3=Urine
4=Rectum
5=Pharynx
6=Eye
7=Sera/Blood
8=Joint
9=Other Anatomic Site
10=Unknown Anatomic Site
360
Y
P1_L1_TestType
As test technology advances, it is important to obtain the type of test performed
This data element should not be ‘null’ or contain missing values.
1=Culture
2=NAAT
3=Non-amplified nucleic acid test/DNA probe
4=Gram Stain
5=DFA
6=Rapid HIV
7=ELISA
8=Western blot (deprecated code, see 27, 28 below)
9=Pooled RNA
10=RPR
11=VDRL
12=FTA
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13=TP-PA
14=MHA
15=Wet Mount/Clue Cell
16=PH
17=Other, not listed
18=Unknown
22=HIV-1 IA (EIA or Other)
23=HIV-1/2 IA (EIA or Other)
24=HIV-2 IA (EIA or Other)
25=HIV-1/2 Ag/Ab
26=HIV-1/2 Type-Differentiating Immunoassay
27=HIV-1 Western Blot
28=HIV-2 Western Blot
29=HIV-1 IFA
30=HIV-1 Culture
31=HIV-2 Culture
32=HIV-1 p24 Antigen
33=HIV-1 RNA/DNA NAAT (Qualitative)
34=HIV-2 RNA/DNA NAAT (Qualitative)
35=HIV-1 RNA/DNA NAAT (Quantitative viral load)
36=HIV-2 RNA/DNA NAAT (Quantitative viral load)
37=CD4 T-lymphocytes
38=CD4 Percent
39=HIV-1 Genotype (PR Nucleotide Sequence)
40=HIV-1 Genotype (RT Nucleotide Sequence)
41=HIV-1 Genotype (PR/RT Nucleotide Sequence)
42=HIV-1 Genotype (IN Nucleotide Sequence)
43=HIV-1 Genotype (PR/RT/IN Nucleotide Sequence)
44=STARHS (BED)
45=STARHS (Vironostika-LS)
46=STARHS ( BIO-RAD AVIDITY)
47=STARHS (Other)
48=STARHS (Unknown)
49=Rapid (Retired)
50=HIV-1/2 Ag/Ab-Distinguishing Immunoassay
51=HIV-1 Genotype (EN Nucleotide Sequence)
52=HIV-1 Genotype (FI Nucleotide Sequence)
53=HIV-1/2 Ag/Ab and Type-Differentiating Immunoassay
54=HIV-1/2 Ag/Ab and Type-Differentiating IA - HIV-1 p24 Antigen Analyte
55=HIV-1/2 Ag/Ab and Type-Differentiating IA - HIV-1 Antibody Analyte
56=HIV-1/2 Ag/Ab and Type-Differentiating IA - HIV-2 Antibody Analyte
57=HIV-1/2 Type-Differentiating Immunoassay (Supplemental)
58=HIV-1/2 Type-Differentiating IA (Suppl) - HIV-1 Antibody Analyte
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59=HIV-1/2 Type-Differentiating IA (Suppl) - HIV-2 Antibody Analyte
60=HIV-1 Genotype (Unspecified)
61=WB/IFA-Legacy
62=RIPA-Legacy
63=Latex Ag-Legacy
64=Peptide-Legacy
65=Rapid-Legacy
66=Iga-Legacy
67=IVAP-Legacy
68=Other HIV Antibody-Other-Legacy
69=Other HIV Antibody-Unspecified-Legacy
70=Viral Load-Other-Legacy
71=Viral Load-Unspecified-Legacy
72=HIV Detection/Antigen/Viral Load-Other-Legacy
73=HIV Detection/Antigen/Viral Load-Unspecified-Legacy
80=Pregnancy
88= Other
99=Not captured
361
Y
P1_L1_QualRes
Qualitative result: For most pathogens/tests, positive, negative,
This data element should not be ‘null’ or contain missing values.
1=Positive
2=Negative
3=Reactive
4=Weakly Reactive
5=Non-Reactive
6=Equivocal/Indeterminate
7=Specimen Inadequate/Contaminated
8=Other
9=Unknown
362
Y
P1_L1_Quantres
Numeric - or Ratio (for RPR/VDRL, e.g. 1:2, 1:4, etc.)
363
P
P1_L1_QuantUnits
Units for quantitative results:
1=Copies/mL
2=Log Copies/mL
3=Cells/Cubic mm
4=CD4%
5=Titer Ratio
6=Cycles/Time (rtPCR)
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Strategy B – Provider Reference Dataset
364
Y
P4_ProvID
Unique identifier for provider/facility
This data element MUST NOT be ‘null’ or contain missing values.
365
Y
P4_ProvName
Name of provider or facility
366
Y
P4_ProvCO
FIPS code for provider/facility physical location
367
Y
P4_ProvZIP
Facility/provider physical location 5-digit ZIP
This data element should not be ‘null’ or contain missing values.
368
Y
P4_UpdateDate
Date provider information last updated/verified
This data element should not be ‘null’ or contain missing values. This
369
Y
P4_LocationLon
Provider physical location longitude
370
Y
P4_LocationLat
Provider physical location latitude
371
Y
P4_CensusTract
Census tract of provider physical location
372
Y
P4_Prov_Fac_Type
Facility or provider type code (PHINVAD compatible)
This data element MUST NOT be ‘null’ or contain missing values.
1=Blood Bank
Includes for-profit sera collection centers
2=Correctional Facilities
Includes jails, prisons, juvenile detention, etc.
3=Day care center (environment)
4=Dentist
5=Drug Treatment Facility
6=Emergency Room/Emergency Department
Include HMO/other urgent care in this category
7=Family Planning Facility
Includes reproductive health clinics
8=Other Federal Agencies
Do not include bureau of prisons in this category (should be 2,
9=HIV Care Facility
Includes and care facility whose primary service is HIV care
10=HIV Counseling and Testing Site
Include HIV outreach & street testing in this category
11=Hospital - Not ED/ER
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Draft: 17 December
2019
This should include in-patient facilities where the patient was
12=Labor and Delivery
13=Laboratory
14=Managed Care/HMOs
15=Mental Health Provider
16=Military
17=National Job Training Program
18=Other, not otherwise specified
19=Other Health Department Clinic
Do not include health department clinics whose primary
20=Other State and Local Agencies
21=Other Treatment Center
22=Pharmacy
23=Prenatal/Obstetrics Facility
24=Private physicians' group office
25=Public Health Clinic
Include ONLY public clinics not otherwise categorized
26=Data/Disease Registries
27=Rural Health Clinic
Includes clinics specifically designated as RHCs on the Centers
28=Categorical STD Clinic
29=School-Based Clinic
30=TB Clinic
31=Tribal Government Clinic
Do not include IHS hospitals (those are coded as 32)
32=Indian Health Service
33=Veterinary Sources
34=Vital Statistics
99=unknown
373
P4_ProvCHC
Is facility/provider a Community Health Center (CHC)?
This data element should not be ‘null’ or contain missing values.
1=Yes
2=No
3=Unknown/Missing
374
P4_ProvFQHC
Is facility/provider a Federally Qualified Health Center (FQHC)?
This data element should not be ‘null’ or contain missing values.
1=Yes
2=No
3=Unknown/Missing
SSuN Cycle 4 (Version 12.2)
Page 135
Draft: 17 December
2019
SSuN Cycle 4 (Version 12.2)
Page 136
| File Type | application/pdf |
| File Title | Microsoft Word - Master_Protocol_Final_V12.2 |
| Author | zpl4 |
| File Modified | 2020-03-24 |
| File Created | 2019-12-17 |