HIV/AIDS Clinical Trial
Official title:
Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical care, and PrEP persistence among young men who have sex with men (YMSM) in the United States for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.
This R21 study, titled "Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM: Collaborative Adaptation and Evaluation", is: 1) adapting the theory-based smartphone app, P3, designed to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence among YMSM in the United States for YMSM in Thailand, and 2) conducting a pilot RCT to assess the feasibility and acceptability of the adapted P3-T app and to examine the potential impact of the app on PrEP adherence. The study is a partnership between Duke University, Chulalongkorn University, Thai Red Cross AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC. P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social networking and game-based mechanics as well as evidenced-based features to improve PrEP medication adherence. P3 is a product born from the collaborative effort of researchers and health game developers working closely with members of the target population in the United States. Built on a successful, evidence-based platform designed by our collaborating technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for customization and adaptations for different cultural and linguistic contexts, and responsive to changes in technology. The social networking features of P3 are designed to capitalize on social involvement as a means through which YMSM can receive information and social support, experience social norms and reflective appraisals, and feel a sense of connectedness to peers. Peers have been recognized as a highly important source of sexual health and HIV prevention information and support among Thai YMSM. The gaming features of P3 are goal-oriented and immersive and provide a challenging and motivating environment for behavior change. As a result, P3 is ideal for engaging YMSM in behavior change, by maintaining attention, avoiding boredom and attrition. The pilot RCT of the adapted P3-T app with be conducted with 60 YMSM newly starting PrEP in Thailand to: 1) assess app feasibility and acceptability, and 2) explore the potential impact of the app on PrEP adherence. The study will be 6 months in duration with a 3-month intervention period and include study visits at baseline, 3-months, and 6-months. At baseline, participants will complete a baseline web-based computer-assisted self-interviewing (CASI) survey. Next, participants will be randomized in a 1:1 ratio into the P3-T arm or standard of care (SOC) study arm. All study participants will complete follow-up CASI surveys and have their blood drawn via venipuncture at 3 and 6 months for collection of dried blood spots (DBS). In-depth interviews will be conducted with 10 P3-T arm participants after the 3-month intervention period. The interview will ask participants about their experience and impressions of the app, how they used it, and how it may have impacted their behaviors during the 3-month intervention period. ;
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