PrEPared, Protected, emPowered (P3)
P3 is a three arm, randomized-controlled trial (RCT) that will test the efficacy of the P3, a novel, theory-based mobile app that utilizes game mechanics and social networking features to improve PrEP adherence, retention in PrEP clinical care and PrEP persistence among young men who have sex with men (YMSM) and trans women who have sex with men (YTW), ages 16-24. We will test the efficacy of P3 and P3+, which adds Next Step Counseling delivered by an adherence counselor through the app, against PrEP standard of care. Participants will be randomized to P3, P3+, or standard of care. A cost comparison between P3 and P3+ will be conducted.
P3 is currently part of the UNC/Emory Center for Innovative Technology. For more information about iTech, click here.
- To optimize the final components P3 and the adherence counseling intervention using iterative design and usability testing.
- To test the efficacy of the P3 intervention app among 240 young men who have sex with men (YMSM) and trans women who have sex with men, ages 16-24, by conducting a three-arm RCT with assessments at Baseline and Week 13 (end of intervention phase) and Week 26 (post-intervention phase). The primary outcome measure is PrEP adherence measured by intracellular tenofovir-diphosphate (TFV-DP) levels from dried blood spots collected at Weeks 13 and 26.
- To conduct a cost comparison between P3 and P3+.
Study Coordinator: Crissi Rainer, MS
Principal Investigators: Lisa Hightow-Weidman, MD, MPH
ClinicalTrials.gov Number: NCT03320512