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

> **NIH NIH UM2** · FLORIDA STATE UNIVERSITY · 2024 · $794,982

## Abstract

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.

## Key facts

- **NIH application ID:** 11100168
- **Project number:** 3UM2HD111102-02S1
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** Lisa B Hightow-Weidman
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $794,982
- **Award type:** 3
- **Project period:** 2024-07-01 → 2030-01-14

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11100168

## Citation

> US National Institutes of Health, RePORTER application 11100168, Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)Scientific Leadership Center; DoxyPep: UM2 Admin Suppl (3UM2HD111102-02S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11100168. Licensed CC0.

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