Research Determination - SURRG

Print Date: 3/27/23

Title:

Strengthening the U.S. Response to Resistant Gonorrhea (SURRG)

Project Id:

0900f3eb82088829

Accession #:

NCHHSTP-BSEB-1/12/23-88829

Project Contact:

Emily R Learner

Organization:

NCHHSTP/DSTDP/BSEB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

01/02/2023

Estimated Completion Date:

07/31/2026

CDC/ATSDR HRPO/IRB Protocol #:
0920-1242

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

3/24/23

Dodson_Janella R. (jhd7) CIO HSC

3/27/23

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

45 CFR 46.102(l)(2)

ICRO:
PRA Applies

OMB Approval date: 4/5/22
OMB Expiration date: 4/30/25

3/27/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

03/15/23

Description:

GC is the third most commonly reported communicable disease in the United States with over 677,000 cases reported in 2020.
Untreated GC can lead to pelvic inflammatory disease, ectopic pregnancy and infertility in women, epididymitis in men,
disseminated infection in men and women, and can facilitate HIV acquisition and transmission. Timely and effective treatment for
GC can prevent these severe adverse health outcomes and onward transmission in the community. However, Neisseria
gonorrhoeae has progressively acquired resistance to each of the antimicrobial agents that have been recommended for treatment
over the past 70 years. Additionally, there is grave concern about N. gonorrhoeae becoming less susceptible to third generation
cephalosporins, including ceftriaxone. Ceftriaxone is the current recommended therapy for uncomplicated urogenital gonorrhea. As
the antibiotic pipeline has dwindled, the threat of untreatable GC continues to increase. Development and spread of strains with
cephalosporin resistance will severely complicate control and prevention of GC. Because GC is primarily diagnosed through nucleic
acid amplification testing (NAAT) technologies, rather than culture, few clinicians readily have access to gonococcal antimicrobial
susceptibility testing (AST). While CDC#s Gonococcal Isolate Surveillance Project (GISP) is critically important for monitoring longterm trends in gonococcal susceptibility to inform treatment guidelines, the susceptibility results are not available quickly enough to
allow for rapid local responses to resistant strains. Developing local and state public health capacity for timely detection of and rapid
response to emerging resistant GC threats is urgently needed to mitigate the spread of resistant GC. Activities funded as a part of
this project will strengthen state and local GC public health infrastructure and build capacity in high-risk local jurisdictions to support
rapid detection of and response to threats of antibiotic-resistant GC. High-risk jurisdictions include: (1) geographic areas at elevated
risk of experiencing emergence of resistant GC based on the historical development of antibiotic resistance in the U.S (e.g., areas in
the western part of the U.S.); (2) areas with local GC epidemics that include large percentages of gay, bisexual, or other men who
have sex with men (MSM); or (3) geographic areas with high GC rates.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

- Enhance timeliness and sensitivity of local surveillance for resistant gonorrhea - Strengthen local resistant gonorrhea response
capacity (programmatic, laboratory and epidemiological) - Enhance local capacity to rapidly conduct gonorrhea case investigations
and partner services, to ensure appropriate treatment of patients with resistant gonorrhea infections, and halt the spread of
identified resistant strains - Evaluate yield and impact of gonorrhea case investigations for halting spread of identified resistant
strains - Develop deeper understanding of sexual networks and gonorrhea transmission (using observational clinical,
epidemiological, network, and genomic data) to identify opportunities for innovative approaches to gonorrhea prevention and control

Objective:

- Substantially increase local specimen collection for Neisseria gonorrhoeae culture and antibiotic susceptibility testing (AST) - Build
and expand local capacity to routinely conduct rapid antibiotic susceptibility testing (AST) capacity (via Etest with ~5 day
turnaround) - Strengthen local data system functionality and interoperability to strengthen surveillance and programmatic response
capacity - Build capacity for local STD programs to conduct enhanced cluster field investigations of and partner services for persons
diagnosed with gonorrhea of public health significance (such as resistant/reduced susceptibility) and those in his/her sexual network
- Ensure appropriate treatment of patients diagnosed with gonorrhea with resistance/reduced susceptibility; ensure partners are
tested and treated - Utilize genomic data of N. gonorrhoeae isolates to support and inform local cluster investigations - Conduct
local and multi-site analyses using clinical, epidemiological, network, and genomic data to identify opportunities for inform cluster
field investigations and develop and evaluate prevention/control interventions

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Yes

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Gonorrhea ; Drug Resistance, Microbial

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided ; CDC employees or agents will obtain or use anonymous or unlinked
data or biological specimens ; CDC employees will provide substantial technical assistance or oversight ; CDC is providing funding

Method Categories:

Analytic Services (can be data/specimen TA for non-research,research,investigations); Culture; Surveillance Support; Technical
Assistance
- Per clinic protocol (determined locally), eligible patients will have swab(s) collected for gonorrhea culture and NAAT at all anatomic

sites of exposure - The local public health lab will perform cultures and conduct AST via Etest on all positive cultures (isolates). All
purified bacterial isolates will be sent onto a regional laboratory for confirmatory AST via agar dilution, and whole genome
sequencing for molecular characterization will be conducted on a subset (no human DNA will be included in the sample). - Public
health disease intervention specialists (DIS) will conduct cluster case investigations and partner services activities (using a
standardized but locally modifiable SURRG case investigation protocol) for all patients identified as having resistant gonorrhea. As
local capacity builds, investigations and partner services for non-resistant infections can be conducted. DIS will collected data from
patients about recent sexual exposures and elicit names and contact information for their recent sexual contacts and up to 2 social
contacts who might benefit from STD screening. DIS will attempt to contact named sexual partners and social contacts, and refer
them to the local STD clinic for STD testing (including gonorrhea culture) and treatment (as appropriate). DIS will attempt to contact
them and refer them to the STD clinic for testing and treatment (as appropriate). - Demographic, clinical, and laboratory data will be
abstracted from the health records participating clinics by the local epidemiological coordinator. Unique patient identifiers will be
assigned locally that will not contain personally identifiable information. These de-identified data will be linked by the locally
assigned identifier and transmitted to CDC following the Secure Access Management Service protocols.

Methods:

Collection of Info, Data or Biospecimen:

- Per clinic protocol (determined locally), eligible patients will have swab(s) collected for gonorrhea culture and NAAT at all anatomic
sites of exposure - Demographic, clinical, and laboratory data will be abstracted from the health records participating clinics by the
local epidemiological coordinator. Unique patient identifiers will be assigned locally that will not contain personally identifiable
information. These de-identified data will be linked by the locally assigned identifier and transmitted to CDC following the Secure
Access Management Service protocols.

Expected Use of Findings/Results and their impact:

Data collected in this project will be used to inform antimicrobial resistant gonorrhea prevention and control efforts in the US.
Findings will be disseminated through peer reviewed journal articles and conference presentations.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

CDC Cooperative
Agreement

CK19-1904 Epidemiology and Laboratory Capacity for Prevention and Control of Emerging
Infectious Diseases

HSC Review

Regulation and Policy

Funding
#

Original
Budget Yr

# Years
Award

Budget
Amount

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff

Staff
Member

SIQT Exp.
Date

Emily
Learner

11/29/2024

Kerry
Mauk

08/17/2023

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical
Practice Exp. Date

12/06/2021

09/24/2021

Staff Role

Email

Phone

Organization

Program
Lead

kvd7@cdc.
gov

404-7187339

BEHAVIORAL SCIENCE &
EPIDEMIOLOGY BRANCH

Data Use
Contact

odf4@cdc.
gov

404-7186272

EPIEMIOLOGY RESEARCH TEAM

Data
DMP
Proposed Data Collection Start Date:

8/1/22

Proposed Data Collection End Date:

7/31/23

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Country/Jurisdiction owns the data with protections under their laws and regulations

Public Access Justification:

Clinical, laboratory, and epidemiological data are data collected and stored by jurisdictions as part of surveillance and public health
activities.

How Access Will Be Provided for Data:

All data transmitted to CDC are de-identified and Secure Access Management Service protocols.

Plans for Archival and Long Term Preservation:

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

03/27/2023

NOA 0920-1242 (2022).

Notice of Action

NOA 0920-1242_2022.pdf

Current

Learner_Emily
(kvd7)
Project Contact

03/15/2023

Attaching original project
determination which includes HS
review (non-research
determination)

Other-Enter new type

SURRG Non-Research Determination-and-ApprovalForm_FNL_6-20-17.pdf

Current

Learner_Emily
(kvd7)
Project Contact

03/15/2023

OMB NOA

Other-Enter new type

SURRG OMB NOA thru 4-30-2025.pdf

Zirger_Jeffrey
(wtj5)
ICRO Reviewer