P3 (Prepared, Protected, emPowered): Promoting PrEP adherence through a social networking, gamification, and adherence support app
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.
The total duration of study participation for each subject is 26 weeks. The duration of the intervention arms is 13 weeks. Youth are followed for 26 weeks.
Total study sample is 276 of which the following will be enrolled for each phase: 1) Up to two rounds of usability testing will be conducted with 12 members of the target population; 2) Field testing will be conducted with 5-8 members of the target population who are initiating PrEP at three of the included SRVs (15-24 total); 240 participants will be recruited to participate in the RCT. Each of the three study arms will include 80 participants.
Participants for all phases will be 1) confirmed HIV-negative; 2) Ages 16 through 24 years; 3) Assigned male sex at birth, self-identify as MSM or transgender female: 4) Able to speak and read English; 5) Have reliable daily access to Android or iOS smartphone with a data plan. Usability and field testing participants will be recruited from SRVs in Bronx, Philadelphia and Houston. RCT participants will be recruited from SRVs in Philadelphia, Chicago, Atlanta, Boston, Bronx, and Houston.
- 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+.