Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial

Abstract

Background Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men’s Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. Objective This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Up program described in a recently published article by Naar et al. Methods This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats—clinic-based versus remote delivery—offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either 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 information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. Results Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. Conclusions We are conducting YMHP in 3 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 the method of delivery. Trial Registration...

Implementation of Evidence-Based Practices to Reduce Youth HIV Transmission and Improve Self-Management: A Survey of Key Stakeholder Perspectives

“…4 The parent study, Scale-It-Up (SIU), operationalizes 4 EBPs at 13 sites across the United States. The EBPs are as follows: The Sequential Multiple Assignment Randomized Trial (SMART), 12 the Young Men's Health Project (YMHP), 13 Tailored Motivational Interviewing Intervention (TMI), 14 and the Adolescent Male Couples-Based HIV Testing Intervention (We Test). 15 The interventions provide a setting for a mixed-methods implementation science study examining the barriers and facilitators to implementing EBPs for HIV prevention and care (ATN Protocol 153 EPIS).…”

Validation of the HIV Pre-exposure Prophylaxis Stigma Scale: Performance of Likert and Semantic Differential Scale Versions

“…To develop the HPSS, we reviewed literature regarding PrEP stigma and identified key sources for items: a study of stigma as a multidimensional barrier, [34] studies of barriers and facilitators to PrEP acceptability, [35,36] measures from the Adolescent Medicine HIV Trials Network for HIV/AIDS Interventions (ATN) U19 Scale It Up, [37,38] and measures from an HIV Prevention Trials Network Study, HPTN082 [39,40]. We sought to include studies representing a broad range of characteristics; in total, there were 1586 participants in these studies, including 402 men, 1171 women, and 7 transgender men; 824 heterosexual, 140 bisexual, and 154 gay/homosexual persons; 666 Black, 250 White, 184 Latino, and 13 Asian; and 400 participants from international settings.…”

Evidence and implication of interventions across various socioecological levels to address pre-exposure prophylaxis uptake and adherence among men who have sex with men in the United States: a systematic review

“…PrEP interventions for MSM were reported to implement in the US South (Florida, Georgia, Texas, Maryland, Mississippi, North Carolina and D.C.) [ 30 – 40 ], Northeast (Pennsylvania, New York, Massachusetts and Rhode Island) [ 27 , 31 – 33 , 36 , 38 , 41 – 49 ], Midwest (Illinois, Michigan, and Wisconsin) [ 24 – 26 , 32 , 33 , 36 , 47 , 50 – 52 ], West (California) [ 51 , 53 – 58 ] and nationwide [ 59 – 63 ]. Thirty-seven of the 42 studies focused solely on MSM [ 24 – 27 , 30 – 34 , 36 – 41 , 43 – 47 , 49 – 54 , 56 , 58 – 72 ], with some targeting Black, Hispanic/Latino MSM or MSM younger than 34 years old [ 24 – 27 , 30 – 34 , 36 – 40 , 44 – 46 , 49 , 50 , 52 , 56 , 58 , 60 – 63 , 70 ]. Five studies were conducted among MSM and other priority populations(e.g., transgender women or heterosexual men) [ 35 , 42 , 48 , 55 , 57 ].…”

“…Access to PrEP was referred to participants’ linkage to healthcare system (e.g., scheduling or attending an appointment for PrEP consultation) [ 25 , 27 , 33 – 35 , 39 , 52 , 58 , 69 – 71 ]. PrEP uptake was measured by self-reported PrEP initiation or a recipient of a prescription for PrEP [ 25 , 30 , 31 , 34 – 36 , 38 , 39 , 43 – 46 , 52 , 54 , 55 , 57 , 58 , 60 , 69 – 72 ]. Adherence to PrEP utilized both behavioral (e.g., self-reported retention in PrEP care or number of doses missed in the past 30 days) [ 30 – 33 , 36 , 40 , 46 , 48 – 51 , 58 , 60 , 73 ] or biological measurements (e.g., PrEP concentration in dried blood spots) [ 24 , 32 , 33 , 37 , 40 – 42 , 53 , 72 ].…”