ATN 142: P3
ClinicalTrials.gov Number: NCT03320512
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.
Lisa Hightow-Weidman, MD, MPH
The total duration of study participation for each subject is 6 months. The duration of the intervention arms is 3 months.
Total study sample is ~265 of which the following will be enrolled for each phase: 1) Usability testing with 8-12 total youth at 2 iTech subject recruitment venues; 2) Field testing will be conducted with 15 total youth who have recently initiated PrEP or are PrEP non-adherent at 3 iTech SRVs; 3) The RCT will be conducted with 240 youth who plan to initiate PrEP, recently initiated PrEP or are PrEP non-adherent at 7 SRVs. The P3, P3+, and standard of care arm will each include 80 participants.
- Ages 16-24
- Assigned male sex at birth
- Reliable daily access to an Android or iOS smartphone with a data plan
- HIV-uninfected (self-report)
- Recruited from one of 8 iTech SRV cities (Atlanta, Georgia; Boston, Massachusetts; Bronx, New York; Chapel Hill, North Carolina; Chicago, Illinois; Houston, Texas; Philadelphia, Pennsylvania; Tampa, Florida)
- Willing to adhere to study collection of whole blood specimens
- More information on eligibility and exclusion criteria available on ClinicalTrials.gov
- 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+.