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pdfSTD Surveillance Network (SSuN)
Project Protocol
&
Implementation Guide
SSuN Cycle 4
(2019 – 2024)
Version 15 Date: Jan 2023
OMB Control# 0920-1072
Version 15
26 January 2023
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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Collaborators (CDC)
Mark Stenger, MA
STD Surveillance Network, Lead Science Officer
Surveillance & Data Science Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Eloisa Llata, MD, MPH
STD Surveillance Network, Science Officer
Surveillance & Data Science Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Marvin Fleming
STD Surveillance Network, Project Officer
Surveillance & Data Science Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
LaZetta Grier
STD Surveillance Network, Data Manager
Surveillance & Data Science Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, Georgia
Kristen Kreisel, PhD
Lead, Enhanced Surveillance and Special Studies Team
Surveillance & Data Science Branch
Division of STD Prevention, NCHHSTP
Centers for Disease Control and Prevention
Atlanta, GA 30333
Associate Collaborators (CDC):
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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
Abigail Norris Turner, PhD
Associate Professor of Medicine,
Division of Infectious Diseases, OSU
410 W. 10th Avenue, N1144 Doan Hall
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
Kathleen Jacobson, MD
California Department of Public Health
Division of Communicable Disease Control
Chief, STD Control Branch
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Roshani Fernando, MPH
California Department of Public Health
STD Control Branch
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Nicole Olsen Burghardt, MPH
California Department of Public Health
STD Control Branch
850 Marina Bay Parkway
Building P, 2nd Floor
Richmond, CA 94804
Florida Department of Health
Craig Wilson
STD & Viral Hepatitis Prevention and Control Section
Florida Department of Health
4052 Bald Cyprus Way, Bin A-19
Tallahassee, FL 32399
Jared Jashinsky, PhD
STD Surveillance Epidemiologist
Florida Department of Health
4052 Bald Cyprus Way, Bin A-19
Tallahassee, FL 32399
Brandi Danforth, MPH
STD Surveillance Epidemiologist
Florida Department of Health
4052 Bald Cyprus Way, Bin A-19
Tallahassee, FL 32399
Indiana State Department of Health
Jamie Black, MPH
Program Coordinator, STD Prevention Epidemiologist
Indiana State Department of Health
2 N. Meridian St.
Indianapolis, IN 46204
Multnomah County Health Department
Christopher Ried, MD
Medical Director, HIV/STD Services, STD Controller
County of Orange Health Care Agency
1725 W 17th Street, POB 6099
Santa Ana, CA 92706
Kim Toevs, MPH
Multnomah County Health Department
Adol. Health Promotion & STD/HIV/HCV Programs
426 SW Stark, 6th Floor
Portland, OR 97204
City of Columbus/Columbus Public Health
Jaime Walters, MPH
Multnomah County Health Department
Community Epidemiology Services
426 SW Stark Street, 3rd Floor
Portland, OR 97204
Audrey Regan, PhD
Director, Sexual Health Promotion
City of Columbus Public Health
240 Parsons Ave.
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New York City Dept. of Health and Mental Hygiene
Preeti Pathela, DrPH, MPH
NYC Department of Health & Mental Hygiene
Bureau of STD Control and Prevention
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
James Williams
Philadelphia Department of Public Health
STD Control Program, Division of Disease Control
500 South Broad Street
Philadelphia, PA 19146
Lenore Asbel, MD
Philadelphia Department of Public Health
Division of Disease Control
500 South Broad Street
Philadelphia, PA 19146
Robbie Madera, MPH
Philadelphia Department of Public Health
Division of Disease Control
500 South Broad Street
Philadelphia, PA 19146
San Francisco Dept. of Public Health
Susan Philip, MD, MPH
San Francisco Department of Public Health
Division of STD Control
1360 Mission Street, Suite 401
San Francisco, CA 94103
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Trang Nguyen, PhD, 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
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
Tyler Fisher
Program Manager
Utah Department of Health
288 North 1460 West, PO Box 142104
Salt Lake City, UT 84114
Washington State Department of Health
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 can 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 in a recipient’s project must meet the volume requirement of at least 5,000 visits per
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year and 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 patient’s 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 IDs 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 is 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 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. 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
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
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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,
including the earliest recorded initial HIV–positive diagnostic test date, HIV viral load
date(s)/result(s) and CD4+ date(s)/result(s) subsequent to October 1st, 2018 with specimen
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collection dates within 12 months of the patient visit or patient disease report (12-month lookback).
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:
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•
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 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 chlamydia cases). This can be done either
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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 fully 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). 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 jurisdiction’s 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
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laboratory 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 included:
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:
_______________________________________________________________________________
Date
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
______________________________________________________________________________
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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| File Type | application/pdf |
| File Title | Microsoft Word - Master_Protocol_Final_V15 |
| Author | zpl4 |
| File Modified | 2023-01-26 |
| File Created | 2023-01-26 |