Randomization CRF in P3 (Prepared, Protected, emPowered): A Study to Test the Efficacy of a Social Networking, Gamification, and Adherence Support App to Improve PrEP Adherence

Randomization CRF SAS
Study Description
This study had three phases, usability testing, field testing, and a randomized-controlled trial (RCT). In usability testing the investigators tested beta versions of the app and gained feedback about the intervention from the target population, identified any technical issues, and got feedback on app content. Field testing was to ensure that the features, platform and content of P3 and P3+ are acceptable to the target population and that there are no technical challenges or user concerns with either the app, the dried blood spot (DBS), hair, or mitra sampling collection.

The last phase was an RCT that tested the efficacy of P3, a novel, theory-based mobile app that utilized game mechanics and social networking features to improve PrEP adherence, retention in PrEP care, and PrEP persistence among young men who have sex with men (YMSM) and young trans women (YTW) who have sex with men, ages 16-24. The investigators tested the efficacy of P3 and P3+, which added adherence counseling through the app, against PrEP standard of care. Participants were randomized to P3, P3+, or standard of care.

For adherence, P3/P3+ was associated with a higher proportion adherent compared to SOC for both outcome measures. The estimated increase in proportion adherent was 0.13 (95% CI: -0.01, 0.27, p-value 0.06) and 0.12 (95% CI: -0.03, 0.26, p-value = 0.11) for TFV and FTC, respectively. There was no evidence of a treatment effect for persistence. Sensitivity analyses led to similar results. Overall, P3/P3+ is associated with an increase in PrEP adherence among YMSM and YTWSM at 3 months. The study population included young men who have sex with men (YMSM) and young trans women (YTW) assigned male at birth who have sex with men, ages 16-24 who started PrEP or were non-adherent to PrEP.