mHealth Technologies to Enhance PrEP Adherence Among Thai MSM
Condition: Adherence, Patient; Pre-Exposure Prophylaxis; HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app
      designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical
      care, and PrEP persistence among young men who have sex with men (YMSM) in the United States
      for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the
      feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.
    

Detailed description: 
      This R21 study, titled "Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM:
      Collaborative Adaptation and Evaluation", is: 1) adapting the theory-based smartphone app,
      P3, designed to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence
      among YMSM in the United States for YMSM in Thailand, and 2) conducting a pilot RCT to assess
      the feasibility and acceptability of the adapted P3-T app and to examine the potential impact
      of the app on PrEP adherence.

      The study is a partnership between Duke University, Chulalongkorn University, Thai Red Cross
      AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and
      includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC.

      P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social
      networking and game-based mechanics as well as evidenced-based features to improve PrEP
      medication adherence. P3 is a product born from the collaborative effort of researchers and
      health game developers working closely with members of the target population in the United
      States. Built on a successful, evidence-based platform designed by our collaborating
      technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for
      customization and adaptations for different cultural and linguistic contexts, and responsive
      to changes in technology.

      The social networking features of P3 are designed to capitalize on social involvement as a
      means through which YMSM can receive information and social support, experience social norms
      and reflective appraisals, and feel a sense of connectedness to peers. Peers have been
      recognized as a highly important source of sexual health and HIV prevention information and
      support among Thai YMSM. The gaming features of P3 are goal-oriented and immersive and
      provide a challenging and motivating environment for behavior change. As a result, P3 is
      ideal for engaging YMSM in behavior change, by maintaining attention, avoiding boredom and
      attrition.

      The pilot RCT of the adapted P3-T app with be conducted with 60 YMSM newly starting PrEP in
      Thailand to: 1) assess app feasibility and acceptability, and 2) explore the potential impact
      of the app on PrEP adherence. The study will be 6 months in duration with a 3-month
      intervention period and include study visits at baseline, 3-months, and 6-months. At
      baseline, participants will complete a baseline web-based computer-assisted self-interviewing
      (CASI) survey. Next, participants will be randomized in a 1:1 ratio into the P3-T arm or
      standard of care (SOC) study arm. All study participants will complete follow-up CASI surveys
      and have their blood drawn via venipuncture at 3 and 6 months for collection of dried blood
      spots (DBS).

      In-depth interviews will be conducted with 10 P3-T arm participants after the 3-month
      intervention period. The interview will ask participants about their experience and
      impressions of the app, how they used it, and how it may have impacted their behaviors during
      the 3-month intervention period.
    

Intervention name(s): P3-T PrEP Adherence App
Intervention type(s): Behavioral
Intervention description(s): P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.
Other intervention name(s): P3-T
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: PrEP adherence; HIV; Young men who have sex with men; YMSM; Thailand; Mobile app; mHealth