Monday, June 30, 2025 6/30/2025

Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)Scientific Leadership Center; DoxyPep: UM2 Admin Suppl

Award Number: UM2HD111102
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2024
PERIOD OF PERFORMANCE END DATE: 11/30/2029

Group Awards By:

View Award Description

Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)Scientific Leadership Center; DoxyPep: UM2 Admin Suppl - PROJECT SUMMARY/ABSTRACT Emerging data indicates that doxycycline prophylaxis (doxyPEP) may be a promising strategy to prevent bacterial STIs. Open-label studies among SMM found that doxycycline 200mg within 72 hours of STI exposure reduced gonorrhea, chlamydia, and syphilis infection by 47-66% among SMM in the United States and France. However, the only data surrounding doxyPEP in cisgender women did not show an impact on STI incidence rates, due to low adherence. While local and state-level public health agencies have advocated for the use of doxyPEP among SMM and trans women with increased likelihood for STIs, these recommendations have not yet been uniformly extended to people AFAB due to lack of data. This study seeks to address this gap by evaluating the acceptability, efficacy, tolerability, and adherence of doxyPEP among young and adolescent people AFAB at increased likelihood of STI exposure through the following aims: Aim 1: Evaluate the efficacy of doxyPEP (both on-demand and weekly dosing) in reducing incident bacterial STIs, compared to standard of care (quarterly STI testing and treatment) among adolescent and young people AFAB; Aim 2: Assess the acceptability and tolerability of doxyPEP among adolescent and young AFAB; Aim 3: Evaluate self-reported adherence and objective use of doxyPEP; Aim 4: Determine the impact of doxyPEP on prevalence of tetracycline resistance in Staphylococcus aureus and Neisseria gonorrhoeae. To achieve these aims, participants will be randomized 1:1:1 to 1) on-demand doxyPEP (doxycycline 200mg within 72 hours of condomless sex), 2) weekly doxyPEP (doxycycline 200mg weekly regardless of sexual exposure), or 3) standard of care (quarterly STI testing and treatment). Participants will participate in quarterly study visits that will consist of sexual behavior surveys, STI testing, and specimen collection, including plasma and hair samples to measure systemic doxycycline levels to assess for objective markers of adherence. Participants will additionally utilize the HealthMPowerment mobile app to promote engagement and adherence as well as to complete weekly surveys evaluating sexual behavior and doxycycline use.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $11,647,748 )
2025	2025	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	001	3	3/24/2025	NON-COMPETING CONTINUATION	$0
2025	2025	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	000	3	12/18/2024	NON-COMPETING CONTINUATION	$11,647,748
2025	2025	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	003	3	5/8/2025	NON-COMPETING CONTINUATION	$0
2025	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	002	2	3/25/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	004	2	5/8/2025	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $11,647,748

Issue Date FY: 2024 ( Subtotal = $11,258,631 )
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	002	2	6/20/2024	NON-COMPETING CONTINUATION	$0
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	001	2	5/3/2024	NON-COMPETING CONTINUATION	$0
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	000	2	12/1/2023	NON-COMPETING CONTINUATION	$9,417,285
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	004	2	9/8/2024	SUPPLEMENT FOR EXPANSION	$794,982
2024	2024	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	003	2	8/21/2024	NON-COMPETING CONTINUATION	$1,046,364
														Subtotal = $11,258,631

Issue Date FY: 2023 ( Subtotal = $13,116,975 )
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	001	1	4/5/2023	NEW	$0
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	000	1	1/24/2023	NEW	$11,162,061
2023	2023	FLORIDA STATE UNIVERSITY	874 TRADITIONS WAY	TALLAHASSEE	FL	32306	LEON	USA	Child Health and Human Development Extramural Research	002	1	9/7/2023	SUPPLEMENT FOR EXPANSION	$1,954,914
														Subtotal = $13,116,975

Grand Total All Awards = $36,023,354

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)Scientific Leadership Center; DoxyPep: UM2 Admin Suppl

Award Number: UM2HD111102

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2024

PERIOD OF PERFORMANCE END DATE: 11/30/2029

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer