DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men
Condition: Adherence, Medication; Risk Behavior; Pre-Exposure Prophylaxis; HIV Prevention
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers are working with a technology company, AiCure, to develop a smartphone app,
      DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is
      time to take their medication, and uses motion-sensing technology to visually and
      automatically confirm the pill was swallowed. The goal of this study is to assess the impact
      of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
    

Detailed description: 
      In the DOT Diary research project, the AiCure automated directly observed therapy (aDOT)
      smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure
      prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses
      automated directly observed therapy (DOT) that use the smartphone camera and artificial
      intelligence software to confirm that the right person is taking the right medication at the
      right time. A sexual diary has been integrated into the aDOT app to assist YMSM in
      understanding whether they are receiving protection from PrEP for individual sexual episodes,
      and when it is particularly important to take PrEP (e.g. after a sexual episode).
      Specifically, the sexual diary allows participants to track sexual encounters, sexual
      behaviors that occurred in each encounter, and rating characteristics of partners. The app
      provides a calendar displaying all days in which PrEP medication was taken, and all days in
      which sexual activity occurred, allowing participants to see coverage of sexual encounters
      with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app
      will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium,
      high), and also provide personalized messages on the additional numbers of doses needed to
      maximize protection.

      In the next stage of app development and assessment, the researchers will conduct the DOT
      Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by
      pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine
      triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess
      the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the
      acceptability and ease of use of the app over a longer (24-week) period. This pilot study
      will allow evaluation and further refinement of the app in preparation for testing in a
      larger efficacy trial among YMSM at risk for HIV acquisition. The researchers will conduct
      this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan
      regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the
      availability and uptake of HIV prevention services, including PrEP. These diverse research
      locations will allow collection of data to inform app development among a broad group of
      YMSM.
    

Intervention name(s): Emtricitabine / Tenofovir Disoproxil Oral Tablet; DOT Diary mobile app
Intervention type(s): Drug; Other
Intervention description(s): Open label daily emtricitabine/tenofovir disoproxil oral tablet; DOT Diary mobile application for tracking medication adherence and sexual activities.
Other intervention name(s): Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adherence; PrEP; HIV Prevention; Truvada; HIV Risk Reduction; Mobile App