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P3 (Prepared, Protected, emPowered): Promoting PrEP adherence through a social networking, gamification, and adherence support app

 

P3 logoP3 is a three arm, randomized-controlled trial (RCT) that tested 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 tested 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 were randomized to P3, P3+, or standard of care. A cost comparison between P3 and P3+ was conducted.

Principal Investigator:
Lisa Hightow-Weidman, MD, MPH | University of North Carolina at Chapel Hill

ClinicalTrials.gov Number: NCT03320512

The total duration of study participation for each subject was 6 months. The duration of the intervention arms was 3 months.

Total study sample is ~265 of which the following were enrolled for each phase: 1) Usability testing with 8-12 total youth in Boston and Chicago; 2) Field testing was conducted with ~15 total youth who have recently initiated PrEP or are PrEP non-adherent in Houston, New York City, and Philadelphia;  3)  The RCT was conducted with 240 youth who plan to initiate PrEP, recently initiated PrEP or are PrEP non-adherent in Atlanta, Boston, Chapel Hill, Charlotte, Chicago, Houston, New York City, Philadelphia, and Tampa. 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
  • Full list of eligibility and exclusion criteria available on ClinicalTrials.gov
  1. To optimize the final components P3 and the adherence counseling intervention using iterative design and usability testing.
  2. 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.
  3. To conduct a cost comparison between P3 and P3+.

Findings

Coming soon!

International AIDS Society (IAS) 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AIDS Impact 2019

 

 

 

 

 

 

 

 

 

 

 

 

International AIDS Society (IAS) 2019