Request for NCHHSTP Project Determination & Approval

12/18/2015

REQUEST FOR NCHHSTP PROJECT DETERMINATION & APPROVAL
NCHHSTP ADS/ADLS Office on behalf of CDC (New, Continuation, or Amendment)

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
([email protected]) of these projects indicates approval by CDC. This review and approval process
complies with obligations for adherence of projects to federal regulations, state laws, ethics guidelines,
CDC policies, and publication requirements.
For research that involves identifiable human subjects in which CDC/NCHHSTP is engaged, use CDC
Human Research Protection Office forms and submit them to CDC Human Research Protection Office
through the NCHHSTP ADS human subjects email box after approval at the branch and division levels.

RELEVANT INFORMATION
What is a project?
A project is defined as a time-limited activity that is funded for a specific period of time, an activity with
specified funds for a limited time, or as a limited time responsibility by specific CDC employees or staff,
including projects that might be ongoing or continuous for an extended period. A project has defined
objectives, tasks (e.g., essential public health services), dedicated resources, and is funded for a specified
time. NCHHSTP reviews and approves projects for the four project categories listed on this form. Every
project officer, project team and staff, NCHHSTP branch, and NCHHSTP division or office is responsible
for submitting this form for each project and for obtaining NCHHSTP OD/ADS or ADLS approval on behalf
of CDC before project initiation, continuation, or amendment. Such programs as surveillance are
approved and funded as specific projects for certain periods.

What is research?
The federal regulations and CDC/OD/ADS office define research as a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition constitute research, regardless if these activities are
conducted or supported under a program that is not considered research for other purposes. For
example, demonstration and service programs sometimes include research activities.

What is a human subject?
A human subject is a living individual about whom an investigator (whether professional or student)
conducting research obtains
1. data through intervention or interaction with the individual or
2. identifiable private information.

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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12/18/2015

What is private information?
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is occurring and information that has been
provided for specific purposes by an individual and that the individual can reasonably expect will not be
made public (e.g., a medical record). Private information identifies individuals (i.e., the identity of the
person is or might be readily ascertained by the investigator or associated with the information) for the
information to constitute research involving human subjects.

What does being “engaged” mean?
An institution becomes “engaged" in human subjects research when its employees or agents intervene
or interact with living individuals for research purposes, or obtains individually identifiable private
information for research purposes. An institution is automatically considered to be engaged in human
subjects research whenever it receives funding or resources (e.g., a direct award) to support such
research. In such cases, the awardee institution has the ultimate responsibility for protecting human
subjects under the award.

What is surveillance?
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health
data essential to the planning, implementation, and evaluation of public health practice, closely
integrated with the timely dissemination of these data to those who need to know. The final link of the
surveillance chain is the application of these data to prevention and control. A surveillance system
includes a functional capacity for data collection, analysis, and dissemination linked to public health
programs.”

What is program evaluation?
Program evaluation is the systematic collection of information about the activities, characteristics, and
outcomes of programs to make judgments about the program, improve program effectiveness, or inform
or guide decisions about future program development. Program evaluation should not be confused with
treatment efficacy, which measures how well a treatment achieves its goals and that can be considered
research.

Sources (links)
 http://intranet.cdc.gov/od/oads/osi/hrpo/
 http://www.hhs.gov/ohrp/index.html

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
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PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
■

Continuation: For projects expected to continue beyond NCHHSTP approved date; include brief description
of changes and attach clean and marked copies of approved determination (approval is for continued work
by CDC/NCHHSTP employees).
Amendment: Include brief description of changes and attach relevant documentation and a copy of
approved project (approval is for continued work by CDC/NCHHSTP employees).

Project Information:
Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
NCHHSTP Project Number:

Division: Division of STD Prevention

Project Location/Country(ies):
United States

Telephone: (404) 639-6136

CDC Project Officer or CDC Co-Leads:

Mark Stenger, Lead Science Officer

Project Dates:
Start 09/30/2019
End 09/29/2024
Laboratory Branch Submission:
If applicable, select the checkbox:

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
■

I. Activity is not human subject research. The primary intent of the project is public health practice or a disease
control activity.
A. Epidemic or endemic disease control activity; collected data directly relate to disease control. If this
project is an Epi-AID; provide the Epi-AID number and documentation of the request for assistance,
per division policy. Epi-AID no.
■

B. Routine disease surveillance activity; data will be used for disease control program or policy
purposes.
C. Program evaluation activity; data will be used primarily for that purpose.
D. Post-marketing surveillance of effectiveness or adverse effects of a new regimen, drug, vaccine, or
device.
E. Laboratory proficiency testing.
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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
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II. Activity is not human subjects research. The primary intent is public health program activities.
A. Public health program activity (e.g., service delivery; health education programs; social marketing
campaigns; program monitoring; electronic database construction or support; development of patient
registries; needs assessments; and demonstration projects to assess organizational needs, management,
and human resource requirements for implementation).
B. Activity is purely administrative (e.g., purchase orders or contracts for services or equipment).
III. Activity is research but does NOT involve identifiable human subjects.
A. Activity is research involving collection or analysis of data about health facilities or other
organizations or units (i.e., not individual persons.)
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research using unlinked or anonymous data or specimens: ALL (1–4) below are required:
1. No one has contact with human subjects in this project; and
2. Data or specimens are or were collected for another purpose; and
3. No extra data or specimens are or were collected for this project; and
4. Identifying information was (one of the following boxes must be checked)
a. not obtained;
b. removed before this submission, or before CDC receipt, so that data cannot be linked
or re-linked with identifiable human subjects; or
c. protected through an agreement (i.e., CDC investigators and the holder of the key
linking the data to identifiable human subjects enter into an agreement prohibiting
the release of the key to the investigators under any circumstances. A copy of the
agreement must be attached.)
IV. Activity is research involving human subjects, but CDC involvement does not constitute “engagement in
human subject research.” Select only one option by checking the box: A indicates the project has current
funding; B or C indicates no current funding is applicable.
A. This project is funded under a grant, cooperative agreement, or contract award mechanism. ALL of
the following 3 elements are required:
1. CDC staff will not intervene or interact with living individuals for research purposes.
2. CDC staff will not obtain individually identifiable private information.
3. Supported institution(s) must have a Federalwide Assurance (FWA), and the project must be
reviewed and approved by a registered IRB or an institutional office linked to the
supported institution’s FWA.*
Supported institution of primary investigator or co-Investigators/entity name:*

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
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Supported institution/entity FWA Number:*
FWA expiration date:*
Expiration date of IRB approval:*
*Attach copy of IRB approval letter(s) supporting project review and approval.
B. CDC staff provide technical support that does not involve possession or analysis of data or interaction
with participants from whom data are being collected (no current CDC funding).
C. CDC staff are involved only in manuscript writing for a project that has closed. For the project, CDC
staff did not interact with participants and were not involved with data collection (no current CDC
funding).

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
12/18/2015

Project Description
Participating project staff must complete all 18 elements of this section.
This is a required description from CDC employees or staff for review and approval of a project plan or
proposal (or for changes) for projects conducted by CDC or in which CDC is involved. All 18 elements
are required to standardize the review and approval process across NCHHSTP, document that all 18
elements have been addressed, expedite review and approval by the NCHHSTP ADS or ADLS office, and
minimize CDC/OD/ADS office audit requests for additional information. A protocol may be attached to
this form, but it does not eliminate the requirement to complete all 18 elements.
PROJECT TITLE: Sexually Transmitted Disease Surveillance Network (SSuN)

Instructions: Use the following boxes to complete the 18 items. Each box will expand as you type, and you are not
limited in the length of your answers. Formatting features and symbols also may be used.
1. CDC Principal Investigator(s) or Project Directors and branch/division/office affiliations:
Mark Stenger, Surveillance and Data Management Branch/DSTDP/NCHHSTP, Lead Science
Officer

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:

Marvin Fleming, Surveillance and Data Management Branch/DSTDP/NCHHSTP, Project Officer

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Eloisa Llata, MD, Surveillance and Data Management Branch/DSTDP/NCHHSTP, Science Officer
Tremeka Sanders, Contractor, Surveillance and Data Management Branch/DSTDP/NCHHSTP, Project Coordinator
LaZetta Grier, Surveillance and Data Management Branch/DSTDP/NCHHSTP, Data Manager

4. Institution(s) or other entity(ies) funding the project:
CDC

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
12/18/2015

5. Project goals:
SSuN supports the goals of NCHHSTP to decrease incidence of infection, decrease morbidity and mortality, and decrease health
disparities associated with HIV, viral hepatitis, STDs and TB by implementing programs and policies that are guided by the principle of
high impact prevention (HIP). In addition, SSuN supports a surveillance framework that enables NCHHSTP to more comprehensively
address the broader, cross-cutting issues of health and wellness by monitoring Health Equity and Program Collaboration and Service
Integration (PCSI). Health equity entails special efforts to improve the health of those disproportionately affected by disease. PCSI
supports programmatic and surveillance efforts to integrate and improve efficiency when addressing syndemics among populations with
or at risk for at least two or more infections in the following areas: HIV, Viral Hepatitis, STD, and TB.

6. Project objectives:
The purpose of this surveillance project is to enhance capacity for STD surveillance and better meet CDC's
disease surveillance mandate. Recipients collaborating in this project will:
1) implement protocol-based sentinel surveillance in STD clinics, including periodic patient surveys and
routine matches with HIV surveillance records, and,
2) implement protocol-based enhanced case surveillance, including HIV registry matching and patient
interviews.

7. Public health (program or research) needs to be addressed:
In light of resurgent sexually transmitted diseases (STDs), and a public health imperative to respond to related epidemics such as HIV, this project proposes new approaches
to community-based enhanced and sentinel surveillance that integrates monitoring of STDs, HIV and behavioral data from populations at risk. The data will be used to identify
opportunities and gaps in prevention and to direct disease control efforts at the local and national level.
Systematic, ongoing collection of patient-level information to monitor the occurrence of, and factors associated with, STDs is the foundation upon which STD control programs
are based. Reporting by clinicians, laboratories and healthcare facilities is limited and does not fully provide information needed to characterize STDs and co-occurring
epidemics, to identify populations at risk for adverse health impacts, or to identify opportunities and gaps in sexual health and preventive services. SSuN addresses these
information needs, and incorporates flexibility to respond to emergent health issues related to STDs by supporting a network of geographically diverse health departments
and STD-related clinical partners implementing protocol-based surveillance activities. These activities complement existing national surveillance strategies such as case
reporting. They also expand the capacity of health departments to collect high-quality, timely data to inform disease prevention and direct control activities.

8. Population(s) or groups to be included:
Populations of specific interest across all strategies in the STD Surveillance Network include persons seeking STD-related care in specialty STD clinical settings and persons diagnosed with gonorrhea and/or syphilis and reported
to collaborating health departments.
collaborating health departments include:
Baltimore City Health Department
California Department of Public Health, STD Control Bureau
Florida Department of Health
Massachusetts Department of Public Health
Minnesota Department of Public Health
Multnomah County Health Department
Philadelphia Department of Public Health
New York City Department of Health and Mental Hygiene
San Francisco Department of Public Health
Washington State Department of Health

9. Project methods:
Strategy A - Sentinel surveillance in STD Clinics:
Following predefined protocols, visit-level demographic, clinical and behavioral information will be extracted from medical records, all patient records will be matched with the jurisdiction's
HIV surveillance registry, and relevant laboratory data extracted. Records will be de-identified, re-formatted and transmitted to CDC every two months for a full census of patients presenting
for care in collaborating facilities.
Strategy B - Enhanced case-based surveillance:
Collaborating jurisdictions will provide a full census of gonorrhea and adult (non-congenital) syphilis reported in their jurisdictions, match all records with the jurisdiction's HIV surveillance
registry. Case records will be de-identified, re-coded and formatted in compliance with protocols and transmitted to CDC on a predetermined schedule. A random sample of gonorrhea and
syphilis cases from this dataset will be identified for enhanced provider and patient investigations. Results of these investigations will be integrated into case datasets and transmitted to
CDC on a predetermined schedule.

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
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10. Selection, inclusion, or sampling of participants (persons or entities):
Collaborating jurisdiction will identify a probability sample of gonorrhea and syphilis cases diagnosed and reported
within their jurisdiction for enhanced surveillance investigations. All reported cases, regardless of source of report or
patient characteristics will have equal probability of inclusion in the sample. No stratification below the county-level is
permitted; sample fraction for selecting the sample of reported cases may be adjusted over time to achieve the
desired representativeness and meet project objectives. Patient investigations among sampled cases are conducted
according to local disease intervention and partner services policies and in compliance with project protocols.

11. Incentives to be provided to participants:

No incentives are provided to participants; no penalties accrue for non-participation.

12. Plans for data collection and analysis:

Participating jurisdictions will submit de-identified datasets to CDC in compliance with project
protocols every month, alternating between Strategy A and B and following a predetermined
data transmission schedule. Participating jurisdictions will conduct local data quality assurance
processes, and data will be merged into de-identified national datasets for analysis and
reporting.
13. Confidentiality protections:
Participating jurisdictions provide a formal memorandum of compliance with NCHHSTP Data
Security and Confidentiality Standards; all patient records submitted to CDC are de-identified
with a non-identifying unique record ID. Data received by CDC are maintained within a
limited-access, secure server environment. Access to the data is strictly controlled by SSuN data
stewards and provided to collaborating analysts on a need-to-know basis. DSTDP has begun
the process of obtaining an Assurance of Confidentiality for SSuN data.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
No additional ethics concerns

15. Projected time frame for the project:
Implementation of the 4th Cycle of the STD Surveillance Network (PS19-1907) will begin
September 30th, 2019; this five-year cooperative agreement will end September 29th 2024.

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
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16. Plans for publication and dissemination of the project findings:
Subject matter experts and science officer collaborating with the STD Surveillance Network
produce routine process and progress reports disseminated to collaborating health departments.
A cross-division CDC advisory group (SSuN Advisory Group) meets semi-annually to coordinate
activities and dissemination of findings to relevant stakeholders. Cross-sectional and trend data
from SSuN are routinely presented at national STD-related conferences and published in
relevant peer-reviewed journals (see references below).

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Attachment 1 - Summary of Changes
Attachment 2 - Project Protocols

Attachment 3 - Approved Project Determination

18. References (to indicate need and rationale for project):
Pitasi MA, Kerani RP, Kohn R, Murphy RD, Pathela P, Schumacher CM, Tabidze I, Llata E."Chlamydia, Gonorrhea, and Human Immunodeficiency Virus Infection Among Transgender Women and Transgender Men Attending Clinics that Provide Sexually Transmitted Disease Services in
Six US Cities: Results From the Sexually Transmitted Disease Surveillance Network (SSuN)', Sexually Transmitted Diseases. 46(2):112–117, Feb 2019. doi: 10.1097/OLQ.0000000000000917.
Mann L, Llata E, Flagg EW, Hong J, Asbel L, Carlos-Henderson J, Kerani RP, Kohn R, Pathela P, Schumacher C, Torrone EA, "Trends in the Prevalence of Anogenital Warts Among Patients at Sexually Transmitted Disease Clinics—Sexually Transmitted Disease Surveillance Network,
United States, 2010–2016", J Infect Dis 2018. Epub ahead of print. DOI: 10.1093/infdis/jiy684
Llata E, Braxton J, Asbel L, Kerani RP, Murphy R, Pugsley R, Pathela P, Schumacher C, Tabidze I, Weinstock HS, "New Human Immunodeficiency Virus diagnoses among Men Who Have Sex with Men attending STD clinics, STD Surveillance Network, January 2010 to June 2013", Sex
Transm Dis. 2018 Sep;45(9):577-582. doi: 10.1097/OLQ.0000000000000802. ISSN: 0148-5717
"Llata E, Braxton J, Asbel L, Chow J, Jenkins L, Murphy R, Pathela P, Schumacher C, Torrone E. "Rectal Chlamydia trachomatis and Neisseria gonorrhoeae Infections Among Women Reporting Anal Intercourse" Obstet Gynecol. 2018 Sep;132(3):692-697. doi:
10.1097/AOG.0000000000002804."
"Ramirez V, Han E, Stoltey J, Nguyen T, Pathela P, Tourdot L, Walters J, Bell T, Torrone E, Stenger M.,""Prescription of Pre-Exposure Prophylaxis to MSM Diagnosed and Reported with Gonorrhea, STD Surveillance Network, 2016"", Sex Transm Dis. 2018 Aug;45(8):e57-e60. doi:
10.1097/OLQ.0000000000000812"
Weston E, Kirkcaldy R, Stenger M, Llata E, Hoots B, Torrone E. "Narrative Review: Assessment of Neisseria gonorrhoeae Infections Among Men Who Have Sex With Men in National and Sentinel Surveillance Systems in the U.S." Sex Trans Dis, 2018 Apr; 45(4):243–249. doi:
10.1097/OLQ.0000000000000740
Weston EJ, Workowski K, Torrone E, Weinstock H, Stenger MR. Adherence to CDC Recommendations for the Treatment of Uncomplicated Gonorrhea — STD Surveillance Network, United States, 2016. MMWR Morb Mortal Wkly Rep 2018;67:473–476. DOI:
http://dx.doi.org/10.15585/mmwr.mm6716a4.
Stenger M, Bauer H, Klingler E, et al. How Good is Your Rule of Thumb? Validating Male-to-Female Case Ratio as a Proxy for MSM-involvement in N. gonorrhoeae Incidence at the County Level. Sex Trans Dis 2018 Mar;45(3):212-215.doi: 10.1097/ OLQ.0000000000000720
Stenger M, Pathela P, Anschuetz G, et. al. "Increases in the Rate of Neisseria gonorrhoeae among Gay, Bisexual and other Men Who Have Sex with Men (MSM) – Findings from the STD Surveillance Network (SSuN) 2010 – 2015", Sex Trans Dis, July 2017;44(7):393-397. doi:
10.1097/OLQ.0000000000000623
Brown, M. J., R. Pugsley, and S. A. Cohen. "Meeting Sex Partners Through the Internet, Risky Sexual Behavior, and HIV Testing Among Sexually Transmitted Infections Clinic Patients." SpringerLink. Arch Sex Behav, 8 Jan. 2015. Web. 27 July 2016. doi:10.1007/s10508-014-0463-3
. Arch Sex Behav (2015) 44: 509. doi:10.1007/s10508-014-0463-3
Kerani, R., M. Stenger, H. Weinstock, K. Bernstein, M. Reed, C. Schumacher, M. Samuel, M. Eaglin, and M. Golden. "Gonorrhea Treatment Practices in the STD Surveillance Network, 2010-2012." Sex Transm Dis 1st ser. 42 (2015): 6-12. Ovid. ASTDA, Jan. 2015. Web. 27 July 2016. doi:
10.1097/OLQ.0000000000000217.
Pathela, P., E. J. Klingler, S. L. Guerry, L. Sarah, K. T. Bernstein, R. P. Kerani, E. Llata, H. D. Mark, I. Tabidze, C. A. Reitmeijer, and SSuN Working Group. "Sexually Transmitted Infection Clinics as Safety Net Providers: Exploring the Role of Categorical Sexually Transmitted Infection
Clinics in an Era of Health Care Reform." Sex Transm Dis 42.5 (2015):286-293. pag. Ovid. ASTDA, May 2015. Web. 27 July 2016. DOI: 10.1097/OLQ.0000000000000255
Kidd, S., A. Zaidi, L. Asbel, T. Baldwin, B. Gratzer, S. Guerry, R. P. Kerani, P. Pathela, K. Pettus, O. O. Soge, A. Stirland, and H. S. Weinstock. "Comparison of Antimicrobial Susceptibilities of Pharyngeal, Rectal, and Urethral Neisseria Gonorrhoeae Isolates among Men Who Have Sex with
Men." American Society for MicrobiologyAntimicrobial Agents and Chemotherapy 59.5 (2015): 2588-595. Antimicrobial Agents and Chemotherapy. American Society for Microbiology, 17 Feb. 2015. Web. 27 July 2016. doi: 10.1128/AAC.04476-14
Llata, E., K. T. Bernstein, R. P. Kerani, P. Pathela, J. R. Schwebke, C. Schumacher, M. Stenger, and H. S. Weinstock. "Management of Pelvic Inflammatory Disease in Selected US Sexually Transmitted Disease Clinics: Sexually Transmitted Disease Surveillance Network, January 2010–
December 2011." Sex Transm Dis 42.8 (2015): 429-33. Ovid. ASTDA, Aug. 2015. Web. 27 July 2016. DOI: 10.1097/OLQ.0000000000000309
Stenger, M., R. P. Kerani, H. M. Bauer, N. Burghardt, G. L. Anschuetz, E. J. Klingler, C. Schumacher, J. Simon, and M. Golden. "Patient-Reported Expedited Partner Therapy for Gonorrhea in the United States: Findings of the STD Surveillance Network 2010–2012." Sex Transm Dis 42.9
(2015): 470-74. Ovid. ASDTA, Sept. 2015. Web. 27 July 2016.
Llata, E., M. Stenger, K. T. Bernstein, S. Guerry, R. P. Kerani, R. Pugsley, P. Pathela, I. Tabidze, H. S. Weinstock, and SSuN Working Group. "Prevalence of Genital Warts Among Sexually Transmitted Disease Clinic Patients—Sexually Transmitted Disease Surveillance Network, United
States, January 2010 to December 2011." Sex Transm Dis 41.2 (2014): 89-93. Ovid. ASTDA, Feb. 2014. Web. 27 July 2016. DOI: 10.1097/OLQ.0000000000000077
Patton, M., S. Kidd, E. Llata, M. Stenger, J. Braxton, L. Asbel, K. T. Bernstein, B. Gratzer, M. Jespersen, R. P. Kerani, C. Mettenbrink, M. Mohamed, P. Pathela, C. Schumacher, A. Stirland, J. Stover, I. Tabidze, R. Kirkcaldy, and H. S. Weinstock. "Extragenital Gonorrhea and Chlamydia
Testing and Infection Among Men Who Have Sex With Men—STD Surveillance Network, United States, 2010–2012." Clinical Infectious Diseases 58.11 (2014): 1564-570. 18 Mar. 2014. Web. 27 July 2016. doi: 10.1093/cid/ciu184
Beymer, M., E. Llata, A. M. Stirland, H. S. Weinstock, C. L. Wigen, S. L. Guerry, E. Mejia, and R. K. Bolan. "Evaluation of Gonorrhea Test of Cure at 1 Week in a Los Angeles Community-Based Clinic Serving Men Who Have Sex With Men." Sex Transm Dis 41.10 (2014): 595-600. Ovid.
ASTDA, Oct. 2014. Web. 27 July 2016. DOI: 10.1097/OLQ.0000000000000190
Stenger, M., M. C. Samuel, G. L. Anschuetz, R. Pugsley, M. Eaglin, E. J. Klingler, M. Reed, C. M. Schumacher, J. Simon, and H. S. Weinstock. "Neighborhoods at Risk: Estimating Risk of Higher Neisseria Gonorrhoeae Incidence Among Women at the Census Tract Level." Sex Transm Dis
41.11 (2014): 649-55. Ovid. ASTDA, Nov. 2014. Web. 27 July 2016. DOI: 10.1097/OLQ.0000000000000195
Cramer, R., J. C. Leichliter, M. Stenger, P. S. Loosier, L. Slive, and SSuN Working Group. "The Legal Aspects of Expedited Partner Therapy Practice: Do State Laws and Policies Really Matter?" Sex Transm Dis 40.8 (2013): 657-62. Ovid. ASTDA, Aug. 2013. Web. 27 July 2016. DOI:
10.1097/01.OLQ.0000431358.18959.d4
Meites, E., E. Llata, J. Braxton, J. R. Schwebke, K. T. Bernstein, P. Pathela, L. E. Asbel, R. P. Kerani, C. J. Mettenbrink, and H. S. Weinstock. "Trichomonas Vaginalis in Selected US Sexually Transmitted Disease Clinics: Testing, Screening, and Prevalence." Trichomonas Vaginalis in
Selected U.S. Sexually Transmitted Disease Clinics: Testing, Screening, and Prevalence 40.11 (2013): 865-69. Ovid. ASTDA, Nov. 2013. Web. 27 July 2016. doi:10.1097/OLQ.0000000000000038
Kirkcaldy, R., P. Augostini, L. E. Asbel, K. T. Bernstein, R. P. Kerani, C. J. Mettenbrink, P. Pathela, J. R. Schwebke, W. E. Secor, K. A. Workowski, D. Davis, J. Braxton, and H. S. Weinstock. "Trichomonas Vaginalis Antimicrobial Drug Resistance in 6 US Cities, STD Surveillance Network,
2009–2010 - Volume 18, Number 6-June 2012 - Emerging Infectious Disease Journal - CDC." Emerging Infectious Disease 18.6 (2012): 939-43. Emerging Infectious Disease. Centers for Disease Control and Prevention, June 2012. Web. 27 July 2016. DOI: 10.3201/eid1806.111590
Dowell, D., L. H. Tian, J. A. Stover, J. A. Donnelly, S. Martins, E. J. Erbelding, R. Pino, H. S. Weinstock, and L. M. Newman. "Changes in Fluoroquinolone Use for Gonorrhea Following Publication of Revised Treatment Guidelines." American Journal of Public Health 102.1 (2012): 148-55.
American Public Health Association -. APHA, Jan. 2012. Web. 27 July 2016. doi: 10.2105/AJPH.2011.300283
Newman, L. M., D. Dowell, K. T. Bernstein, J. A. Donnelly, S. Martins, M. Stenger, J. Stover, and H. S. Weinstock. "A Tale of Two Gonorrhea Epidemics: Results from the STD Surveillance Network." Public Health Reports. Association of Schools of Public Health, May-June 2012. Web. 27
July 2016.
Meites, E., E. Llata, S. Hariri, J. Zenilman, L. Longfellow, J. Schwebke, I. Tabidze, C. J. Mettenbrink, H. Jenkins, S. Guerry, P. Pathela, L. E. Asbel, J. A. Stover, K. T. Bernstein, R. P. Kerani, E. F. Dunne, and L. E. Markowitz. "HPV Vaccine Implementation in STD Clinics—STD Surveillance
Network." Sex Transm Dis 39.1 (2012): 32-34. Ovid. ASTDA, Jan. 2012. Web. 27 July 2016. DOI: 10.1097/OLQ.0b013e3182315584
Llata, E., R. Puglsey, I. Tabidze, L. E. Asbel, K. T. Bernstein, R. P. Kerani, J. A. Schwebke, L. Longfellow, C. J. Mettenbrink, S. Guerry, J. Zenilman, E. J. Klingler, and H. S. Weinstock. "Prevalence of Anogenital Warts among STD Clinic Patients--STD Surveillance Network, USA, January
2010–September 2010." Sex Transm Infect 87.Supplemment 1 (2011): A120. Sexually Transmitted Infections: Poster Sessions. BMJ, July 2011. Web. 01 Aug. 2016.
Rietmeijer, C. A., J. Donnelly, K. T. Bernstein, J. M. Bissette, S. Martins, P. Pathela, J. A. Schillinger, M. Stenger, H. S. Weinstock, and L. M. Newman. "Here Comes the SSuN: Early Experiences with the STD Surveillance Network." Public Health Reports. Association of Schools of Public
Health, 2009. Web. 27 July 2016.

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
12/18/2015

PROJECT APPROVAL
Choose one of the following options (Division or Center/OD Project)
■

DIVISION PROJECT

NCHHSTP BRANCH AND DIVISION ADS REVIEW AND APPROVAL (Sign electronically by clicking next to the X
and following the prompts)

X

Hillard
Weinstock -S

Digitally signed by Hillard
Weinstock -S
Date: 2019.05.30 13:47:42
-04'00'

Branch Chief or Branch Science Officer

X

Jami Leichliter
-S

Digitally signed by Jami
Leichliter -S
Date: 2019.05.30 12:08:24
-06'00'

Division ADS, Acting ADS, or Deputy ADS

CENTER/OD PROJECT

NCHHSTP OD OFFICE REVIEWS AND APPROVALS (Sign electronically by clicking next to the X and following
the prompts)

X

X

Office Associate Director or Designee

NCHHSTP ADS or Designee

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Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)

Date received in NCHHSTP ADS or ADLS office: 05/30/2019
Date received by NCHHSTP Deputy ADS or ADLS: 05/31/2019
Select the checkbox for each applicable comment for Nos. 1–5 or select the checkbox for No. 6 if all of the comments apply.
Additional applicable comments may be added to No. 7. If additional information is required before approval can be
granted, select No. 8.
■

1. This project is approved by NCHHSTP/CDC and CDC (per CDC policies and federal regulations) for CDC staff
participation.

■

2. Participating partners and sites must obtain project review and approval, according to their institutional
policies and procedures and according to local, national, and international regulations and laws, including
45 CFR 46 regulations and state laws. CDC project officers must maintain a current copy of local sites’
approvals in project records.

■

3. CDC investigators and project officers need to adhere to the highest ethics standards of conduct and to
respect and protect the privacy, confidentiality, autonomy, data, welfare, and rights of participants and
integrity of the project. All applicable country, state, and federal laws and regulations must be followed.
4. Informed consent or script is needed as required by laws and regulations. Information conveyed in an
informed consent or script process needs to address all applicable required elements of informed consent.
Consent of employees in related projects about their institutions needs to include a statement that their
voluntary participation or withdrawal would not affect their employment status or opportunities.
5. OMB Paperwork Reduction Act determination by the NCHHSTP OMB/PRA Coordinator might be needed for
this project.
6. All previous comments apply.
7. Other applicable comments: Type your comment in the box. The space will expand as you type.

8. More information is required before approval is granted: Explain what additional information is requested by
typing in the box. The space will expand as you type.

Date Information was requested:
Date Information was received:

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12/18/2015

Approval must be granted by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Associate
Director for Science (ADS), Acting ADS, or Deputy ADS, or for laboratory-associated projects, by the Associate
Director for Laboratory Science (ADLS) or Acting ADLS.

Project Title: Sexually Transmitted Disease Surveillance Network (SSuN)

X

signed by Amy L.
Amy L. Sandul Digitally
Sandul -S
Date: 2019.06.03 09:30:26
-S
-04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

Page 12 of 12