# Preventing Premature Pre-Exposure Prophylaxis Discontinuation and Sexually Transmitted Infections Among Men Who Have Sex With Men (Project PEACH): Protocol for a Prospective Cohort Study

## TL;DR

This study tracks how men who have sex with men choose and change HIV and STI prevention methods over time to help reduce infections.

## Contribution

The study introduces a flexible, patient-preference trial design to evaluate PrEP and doxyPEP use and discontinuation among MSM.

## Key findings

- Most participants chose daily PrEP combined with doxyPEP for HIV and STI prevention.
- The study enrolled a diverse group of MSM in Atlanta, with 60% selecting the combination of daily PrEP and doxyPEP.
- Participants had the flexibility to switch prevention methods at any time during the study.

## Abstract

There is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic.

We designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP.

We enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing.

We enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%).

We designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention.

Clinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093

DERR1-10.2196/56096