Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial
Authors: Edwards Gabriel G , Reback Cathy J , Cunningham William E , Hilliard Charles L , McWells Charles , Mukherjee Sukrit , Weiss Robert E , Harawa Nina T 
Published: July 2020

Background
Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one’s social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women.

Objective
The purpose of this study is to test a new intervention—Mobile-Enhanced Prevention Support (MEPS)—that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services.

Methods
A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism.

Results
Enrollment began in November 2019 and study completion is expected in 2023.

Conclusions
This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant–peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm.

Trial Registration
ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396

International Registered Report Identifier (IRRID)
PRR1-10.2196/18106