Multi-Level Factors Influencing Viral Suppression and Stimulant Use in U.S. Men who have Sex with Men: Protocol for a National, Remote-Contact, Observational Cohort Study (Preprint)
BACKGROUND Stimulant use among men who have sex with men (MSM) is on the rise, threatening progress towards the U.S. Ending the HIV Epidemic (EHE) goals. Antiretroviral (ART) nonadherence is a key contributor to poor HIV treatment outcomes. As one of the strongest determinants of ART nonadherence, hazardous stimulant use, alongside other multi-level factors, must be examined to determine the best approaches to ensure improved HIV treatment adherence. Current methods for measuring adherence are either inaccurate or unavailable at the point-of-care. Objective, point-of-care adherence monitoring may offer a new solution to rapidly measure ART nonadherence. OBJECTIVE This study used fully remote-contact methods to develop a U.S. national cohort to assess the impact of the stimulant epidemic on both ART adherence and viral suppression. The primary outcomes are viral suppression and the acceptability and feasibility of remote study procedures, with stimulant use examined as a key predictor of both. METHODS The American Remote Contact HIV Epidemiology Study (ARCHES) is a large, remote observational cohort of 1,000 MSM living with HIV who have suboptimal ART adherence. ARCHES examines multi-level factors that influence viral suppression, stimulant use, and ART adherence among MSM, while evaluating the acceptability and feasibility of remote study procedures. The study aimed to recruit over 40% Black MSM, with a high proportion (>70%) of the sample self-reporting stimulant use. Enrolled participants were living with HIV, ≥ 18 years old, with self-reported sub-optimal ART adherence within the last 12 months. Viral suppression was measured using viral loads from remote phlebotomy appointments, stimulant use via self-report and self-collected hair sample analysis, and ART adherence using a urine-based POC lateral flow assay. Acceptability and feasibility were evaluated through participant retention over four years and survey data. RESULTS Recruitment of the observational cohort began in October 2023 and concluded in September 2024. Recruitment goals were met, with 40.3% Black participants and 71.6% stimulant users enrolled. Data collection is underway, with anticipated completion in 2027. CONCLUSIONS Findings from this large-scale national, remote study will elucidate factors that influence ART adherence. Remote enrollment had the benefit of reaching a diverse sample of individuals less engaged in care, but it also required careful coordination of sample shipments and fraud detection. Furthermore, the geographical and sociodemographic diversity of this cohort will help identify geographic, structural, and social barriers to HIV care engagement and viral suppression. This cohort also oversampled for Black participants and participants who use stimulants, two groups commonly underrepresented in similar cohorts. Collectively, these findings will inform future adherence interventions and support efforts to end the U.S. HIV epidemic.