Advancing PrEP Delivery: A Randomized Controlled Trial for Use of ePrEP to Expand PrEP Access to Non-Urban Young Black MSM (Preprint)

BACKGROUND Pre-exposure prophylaxis (PrEP) is highly efficacious for preventing HIV but has not yet been brought to scale among at-risk persons. In several clinical trials in urban areas, technology-based interventions have shown a positive impact on PrEP adherence. In rural and small-town areas in the United States, which often do not have geographically proximal access to PrEP providers, additional support may be needed. This may be particularly true for younger persons, who are more likely to face multiple barriers to accessing PrEP services. Home-based care, accomplished through a tailored smartphone application (app), specimen self-collection (SSC), and interactive video consultations, could increase both PrEP initiation and persistence in care. OBJECTIVE Our goal is to assess the initiation and persistence in PrEP care for those randomized to a home-care intervention (ePrEP) relative to those assigned to the standard of care (control) condition. We will conduct additional assessments, including quantitative and qualitative analyses, to contextualize trial results and facilitate scale-up. METHODS This two-arm, randomized controlled trial will enroll young men who have sex with men (YMSM) aged 18-24 from rural areas of Georgia, Mississippi, and North Carolina. The trial will seek to recruit a diverse sample, targeting 50% participation among highly impacted groups of Black or Latino MSM. Intervention participants will receive a study app that incorporates a messaging platform, a scheduling and milestone-based tracking system for PrEP care progress, electronic behavioral surveys, and interactive video consultations with a clinician. Complemented by SSC kits mailed to laboratories for standard PrEP-related monitoring, the ePrEP system will allow participants to access PrEP care without leaving their homes. YMSM randomized to the control condition will receive a listing of nearest local PrEP providers to receive standard PrEP care. Both groups will complete quarterly electronic surveys. The primary outcome, assessed at 6 and 12 months after randomization, will be the difference in the proportion of intervention versus control participants that achieve protective levels of the active metabolite of oral PrEP (tenofovir diphosphate). RESULTS Enrollment is anticipated to begin in March 2019, with study completion in 2022. CONCLUSIONS This trial will determine whether home PrEP care provided through an app-based platform is an efficacious means of expanding access to PrEP care for a diverse group of YMSM in rural and small town areas of the United States. CLINICALTRIAL University of North Carolina Institutional Review Board (#18-0107); ClinicalTrials.gov NCT03729570