JMIR Publications

ABSTRACT

Background:

Young men who have sex with men (YMSM) are disproportionately at risk for human immunodeficiency virus (HIV) and sexually transmitted infections (STIs). Adapting and testing the effectiveness of the Young Men’s Health Project (YMHP) at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM.

Objective:

To adapt YMHP for clinic and remote delivery by existing clinic staff and compare the effectiveness of both in real world adolescent HIV clinics.

Methods:

This is a comparative effectiveness hybrid Type 2 trial of the YMHP intervention with two delivery formats – clinic-based versus remote delivery – offered following HIV counseling and testing. Phase I includes conducting focus groups with youth as part of its formative research to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation both in the clinic setting and via remote delivery. Phase II includes recruitment and enrollment of 270 YMSM, ages 15-24, 90 at each of the three sites. Enrollment will be limited to HIV-negative YMSM who report recent drug use and either condomless anal sex (CAS) or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions. Once CHWs demonstrate competence according to the Motivational Interviewing Treatment Integrity (MITI), fidelity will be monitored throughout the trial. Sessions will be audio-recorded for MITI fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period.

Results:

Phase I focus groups were completed in July 2017 (N = 25). Feedback from these focus groups at the three sites informed adaptations to the YMHP intervention manual, implementation of the YMHP intervention as a clinical trial, and recruitment plans for Phase II. Baseline enrollment for Phase II is expected to begin in June, 2018 and assessment of intervention outcomes will be at immediate post-test (IP)-, 3-, 6-, 9-, and 12-months after the intervention, . Upon collection of both baseline and follow-ups data, we will compare the effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access and assess the cost-effectiveness of both delivery formats of YMHP.

Conclusions:

We are conducting YMHP in three cities with high rates of YMSM at risk for HIV and STIs. When adapted for real world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by method of delivery. Clinical Trial: NCT03488914