Research Determination - GC Sharp

Project Determination
GC SHARP Expansion of rapid gradient strip antibiotic sensitivity testing,
whole genome sequencing, and molecular detection assays for clinical
management and local strain surveillance of gonorrhea
Project ID:

0900f3eb81ff52e2

Accession #:

NCHHSTP-STDLRRB-10/4/22-f52e2

Project Contact:

Jennifer Reimche

Organization:

NCHHSTP/DSTDP/STDLRRB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

10/31/22

Estimated Completion Date:

07/31/29

CDC/ATSDR HRPO/IRB Protocol#:
OMB Control#:

Description
Priority
Standard

Date Needed
10/31/22

Determination Start Date
10/05/22

Description
The Division of STD Prevention in collaboration with the Antibiotic Resistance Coordination Strategy Unit (ARx) is supporting state and local public health
laboratories, as a part of the Antimicrobial Resistance Laboratory Network (ARLN), to build capacity for rapid gradient strip antibiotic susceptibility testing (AST),

with the option to perform whole genome sequencing (WGS) and/or molecular detection of antimicrobial resistance (AR) markers. Funding for expansion of these
activities comes from the American Rescue Plan under the Strengthening HAI/AR Program Capacity supplement (SHARP) Project II. To enhance clinical
management of gonorrhea, clinicians or laboratories will be able to submit gonorrhea specimens or isolates for CLIA-compliant testing for azithromycin, cefixime,
ceftriaxone, and ciprofloxacin susceptibility to their state, county, or other public health laboratory. Specimens will be accepted from cases such as routine AST,
potential treatment failure (e.g. where a patient persistently tests positive and has continued symptoms after therapy and reinfection has been ruled out by clinical
assessment), test of cure, suspected exposure, or disseminated gonococcal infection. Depending on specimen volume and operational considerations, some of the
isolates or specimens will be routed to regional AR laboratories, i.e., ELC-funded public health laboratories that perform gonorrhea AR laboratory testing in other
DSTDP projects such as GISP, eGISP, and SURRG, as described and approved in other project determinations for these projects. CDC will collect delinked data
associated with submissions made to either SHARP-funded sites or the regional laboratories in order to monitor occurrences of cephalosporin non-susceptible
isolates and for program evaluation of the lab’s capacity to implement testing in their jurisdiction, monitor their progress, and determine where they face
challenges. Isolates at CDC will be used for confirmatory antibiotic sensitivity testing (using the gold standard agar dilution method) and, where appropriate, whole
genome sequencing and AR marker molecular assays. Data generated at the public health laboratories may be used locally for surveillance and public health
response. Collection of data by CDC will enhance surveillance and understanding of gonorrhea cases of concern.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure Submission
No

IMS Activation Name
Not selected

Select the primary priority of the project
Not selected

Select the secondary priority(s) of the project
Not selected

Select the 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

The purpose of this project is to support and expand access to rapid antimicrobial susceptibility testing for clinical management of gonorrhea to the state and local
public health laboratory level, especially in cases where test of cure (e.g. in pharyngeal infections) reveals persistent infection despite recommended treatment and
when reinfection has been ruled out. Increased testing will enhance surveillance of gonorrhea cases with reduced susceptibility to antibiotics at CDC and the state
or local public health lab level. Rapid antimicrobial susceptibility testing under CLIA at the public health labs will enable results to be reported to submitters to
improve patient care and public health practice. Supporting the development of whole genome sequencing workflows at state public health labs will empower more
jurisdictions to perform their own genomic analyses to augment local response. The use of molecular AR marker assays in the STD Laboratory Reference and
Research Branch (SLRRB) at CDC, and eventually at AR Laboratory Network regional labs, will enable more rapid detection of AR markers for use when culture is
not possible, or an outbreak of non-susceptible N. gonorrhoeae may be suspected. This program will help expand access to these tests to more jurisdictions
throughout the country and enhance experience in gonorrhea testing at the state and local public health laboratory level.

Objective
1) To evaluate the implementation of testing at state and local public health labs DSTDP will collect data associated with testing submissions (eg. How many
submitters and testing turn-around-time); this may inform testing program planning and expansion in the future. 2) To augment surveillance of antimicrobial
resistance gonorrhea and support state and local public health practice CDC will be notified of isolates of concern (those with cephalosporin minimum inhibitory
concentrations above a define threshold) within 24 hours, and CDC may request the isolates be shared for confirmatory testing and additional molecular
characterization at SLRRB. 3) Sequencing IDs and NCBI SRA BioSample IDs will be shared with SLRRB for isolates of concern that are analyzed by whole genome
sequencing at participating public health laboratories. 4) SLRRB will support state and local public health labs with the expansion of GC testing and investigation of
isolates of concern to facilitate local surveillance and enhance public health practice.

Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been
excluded or marginalized and/or decreasing disparities?
Yes

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

Secondary Data or Specimen Analysis; Purchase, Use, or Transfer of Information, Data, Biospecimens or Materials

Target Population to be Included/Represented
General US Population; Other-Disadvantaged persons and populations who are disproportionally affected by STIs

Tags/Keywords
Gonorrhea; Treatment Failure; Sexually Transmitted Diseases, Bacterial

CDC's Role
CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens; CDC is providing funding

Method Categories
Secondary Data Analysis; Secondary Specimen Analysis

Methods
Submitting providers and laboratories will request testing of isolates/specimens collected during a clinical encounter (no additional specimens will be collected).
AST will be conducted under CLIA compliance by the participating AR Laboratory Network labs using gradient strip antimicrobial susceptibility testing. Specimen
data will be entered into a web-portal (REDCap) and only deidentified data will be shared with CDC. Copies of frozen isolate stocks will be stored at SLRRB or
archived at the CDC Biorepository; copies of isolates of concern may also be submitted to the AR Isolate Bank. SLRRB may confirm isolate identification and
perform confirmatory AST (gold-standard agar dilution, as well as Etest), whole genome sequencing, and molecular assays for AR markers on the isolates of
concern.

Collection of Info, Data, or Bio specimens
Specimen data will be entered into a web-portal and only delinked data will be shared with CDC. Specific data fields include patient age, gender, travel history,
state of submitting facility, collection date, specimen source, date specimen received for testing, reason for testing, treatment administered to patient (if suspected
treatment failure), minimum inhibitory concentrations, and sequencing ID (if applicable). Isolates with concerning reduced antibiotic susceptibility will be shared
with CDC by the labs as frozen stocks. Jurisdictions that perform whole genome sequencing will upload raw, quality-controlled sequencing data to NCBI Sequence
Read Archive (SRA) where it will be publicly available; sequencing IDs for isolates will be assigned by SLRRB or the jurisdiction will share the IDs with SLRRB (via
emailed form or REDCap). Any confirmatory data generated by SLRRB and shared with the state/local public health labs will not be incorporated into patient
records. WGS data generated at SLRRB will be uploaded to NCBI within 120 days of generating the data. Frozen stocks of isolates of concern will be stored at CDC.

Expected Use of Findings/Results and their impact
Specimen data will be used to determine the utility of offering rapid AST services. Information such as reasons for testing request, specimen sources, etc. may
provide important insight on improved ways to direct public health resources for antibiotic resistant gonorrhea control and prevention. Genetic characterization of
isolates with reduced antibiotic susceptibility associated with treatment failure cases could help identify circulating strain types or resistance markers which in turn
could inform surveillance strategies.

Could Individuals potentially be identified based on Information Collected?
Yes

Will PII be captured (including coded data)?
Yes

Does CDC have access to the Identifiers (including coded data)?
No

Is this project covered by an Assurance of Confidentiality?
No

Does this activity meet the criteria for a Certificate of Confidentiality (CoC)?
No

Is there a formal written agreement prohibiting the release of identifiers?
Yes

Funding
Funding Type

Funding Title

Funding #

Original Fiscal
Year

# of Years
of Award

CDC Cooperative

Epidemiology and Laboratory Capacity for

CK19-1904

2019

5

Agreement

Prevention and Control of Emerging

Budget
Amount

Infectious Diseases

HSC Review
HSC Attributes
Other - This project activity involves secondary data analysis to support and expand access to rapid antimicrobial susceptibility
testing for clinical management of gonorrhea to the state and local public health laboratory.
Yes

Regulation and Policy
Do you anticipate this project will be submitted to the IRB office
No

Institutions
Institution

FWA #

FWA Exp.
Date

IRB Title

IRB Exp. Date

Funding #

Staff
Staff Member

SIQT Exp.
Date

Citi
Biomedical
Exp. Date

Cau Pham

09/23/2025

01/07/2022

Citi Social
and
Behavioral
Exp. Date

Citi Good
Clinical Exp.
Date

Staff Role

Email

Phone #

Organization/
Institution

04/22/2022

Technical

whi4@cdc.g

404-718-

STD

Monitor

ov

5642

LABORATORY
REFERENCE &
RESEARCH
BRANCH

Ellen Kersh

10/22/2024

02/01/2025

Program Lead

egk6@cdc.

404-639-

STD

gov

2728

LABORATORY
REFERENCE &
RESEARCH
BRANCH

Jennifer Reimche

09/14/2025

10/21/2025

Principal

nkv3@cdc.

404-718-

STD

Investigator

gov

7985

LABORATORY
REFERENCE &
RESEARCH
BRANCH

John Cartee

10/04/2025

01/07/2022

Co-Investigator

yil5@cdc.go

404-639-

GENETIC

v

3826

PHYLOGENY

DMP
Proposed Data Collection Start Date

10/31/22

Proposed Data Collection End Date

07/31/29

Proposed Public Access Level

Public

Public Access justification

Aggregated summaries of data collected may be made public through publications and
presentations to help expand capacity for rapid AST for clinical management of gonorrhea.
Genetic/genomic data associated with any isolates sequenced will be released consistent with
agency policies.

How Access Will Be Provided for Data

CDC will not receive any personal identifiers for specimens tested. All line-listed data (which does
not contain PII) is housed on CDC servers with restricted access that is limited to project staff.

Plans for archival and long-term preservation of

Specimen data will be stored electronically in restricted access storage locations. Isolates shared

the data

with CDC will be archived at CDC.

Spatiality (Geographic Location)
Country

State/Province

County/Region

United States

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:

Not Research - Public Health Surveillance

10/11/22

Dodson_Janella R. (jhd7) CIO HSC

10/12/22

Bonds_Constance (akj8) CTR OMB/PRA

Does NOT Require HRPO
Review

45 CFR 46.102(l)(2)

Research Not Involving Human Subjects

45 CFR 46.102(e)
PRA:

Qualifies for a regulatory exclusion: No Information being

PRA does not apply

collected

Coordinator

Justification: OMB PRA is not applicable to this secondary delinked data / specimen analysis. No new data are being
collected.
ICRO:
Concur

10/12/22

Zirger_Jeffrey (wtj5) ICRO Reviewer