Adapting Effective mHealth Interventions to Improve Uptake and Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Thai Young MSM: Protocol for a Feasibility Trial (Preprint)

BACKGROUND Young men having sex with men (YMSM) are the fastest-growing HIV+ population worldwide. Thailand has the highest adult HIV seroprevalence in Asia; over 25% men having sex with men in Bangkok are HIV positive. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for all at-risk individuals. PrEP is highly effective when taken as prescribed, but PrEP utilization has been low and adherence is often inadequate. OBJECTIVE We propose to develop and pilot a multi-component, technology-based intervention to promote both motivation to begin PrEP (“uptake”) and sustained adherence to PrEP among HIV-negative, Thai YMSM. We will adapt an existing two-session, technology-delivered, motivational interviewing-based intervention to focus on PrEP use in YMSM in Thailand. The resulting intervention is called the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also develop Motivational Interactive Text Messaging (MTM) to send two-way motivational messages to promote PrEP use. METHODS The proposed study includes 3 phases. Phase I includes in-depth interviews with HIV-negative Thai YMSM and providers to explore barriers and facilitators of PrEP initiation and adherence to inform intervention content. Phase II consists of adapting and beta-testing MES-PrEP and MTM for functionality and feasibility using a youth advisory board of Thai YMSM. In Phase III, we will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of MAS-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. Sixty HIV-negative Thai YMSM who have not started PrEP and 60 YMSM who are on PrEP but not adherent to it will be randomized 2:1 to receive MES-PrEP and MTM (n=40) or Standard PrEP Counseling (n=20). Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. Participants will complete the assessments at baseline and 1, 3, and 6 months post-intervention. Biomarkers of adherence to PrEP and HIV/STI will be collected. RESULTS Upon project completion, we shall have developed a highly innovative mHealth intervention to support MSM using PrEP which will be ready for testing in a larger efficacy trial. CONCLUSIONS This study addresses a critical problem (high HIV incidence and low PrEP use) among Thai young men who have sex with men. We are developing two potentially synergistic technology-based, theory-driven interventions aimed at maximizing PrEP use. The proposed project has the potential to make significant contributions to advancing HIV prevention research and implementation science. CLINICALTRIAL ClinicalTrials.gov NCT05243030