Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial (Preprint)

Abstract

Background: HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidencebased interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile applications can be utilized to increase PrEP adherence for many YMSM and YTWSM. Objective:The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile application built on an established health platform, which includes interactive social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging through the app. Methods:The formative research phase includes usability testing to assess users' comprehension of P3's educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A threearm RCT (P3, P3+, standard of care) will then be conducted at six iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the two intervention arms.Results: This is an ongoing research project with initial results from the formative work expected in 2020 and RCT results in 2021.Conclusion: P3 features aim to provide an engaging, interactive approach that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and will ensure that the users' needs are met in a familiar, stimulating way. If efficacious, P3 would be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions.Trial Registration: ClinicalTrials.gov NCT03320512.Keywords: pre-exposure prophylaxis; gamification; young men who have sex with men; young transgender women who have sex with men; adherence; smartphone; applications (app); mHealth