PrEP SMART Phase I Trial
Condition: At Risk for HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency
      management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis
      (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, "the
      app").
    

Detailed description: 
      The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency
      management (CM) targeting adherence to oral HIV antiretroviral pre-exposure prophylaxis
      (PrEP) administered via a smartphone-based medication adherence platform (PrEP SMART, "the
      app").

      PrEP provides a strong preventative benefit to individuals at-risk for HIV. While oral PrEP
      adherence is highly correlated with its efficacy in clinical trials, adherence rates are
      variable and range from 29-80%. In real-world practice settings, PrEP adherence may even be
      lower. As such, interventions are needed to improve and sustain adherence to oral PrEP,
      thereby maximizing preventative benefits in at-risk populations.

      CM is a behavioral intervention that involves the systematic use of reinforcement dependent
      on the occurrence of a predefined behavior. CM improves adherence to antiretroviral therapy
      and post-exposure prophylaxis, but CM has yet to be applied to PrEP adherence. The
      investigative team recently developed a smartphone-based platform for medication adherence
      that can integrate CM. Given that mobile technologies such as smartphones are increasingly
      ubiquitous, a CM-based program administered via smartphone may be a practical intervention
      that augments PrEP adherence.

      In the proposed research, PrEP SMART will provide medication reminders; monetary incentives
      for daily, verified adherence to PrEP; education about oral PrEP; and assess potential
      adherence barriers. This will be a 4-week open-label, stage I trial in a community sample of
      young men who have sex with men (YMSM, n = 12) already prescribed and taking oral PrEP (ages
      18-30). YMSM were selected because they are the only high risk group experiencing an increase
      in HIV incidence in the U.S.

      The investigative team is particularly well-positioned as we have expertise in the
      development of mobile apps to improve medication adherence, including in the context of HIV
      care; oral PrEP efficacy trials; and are conducting research using the "parent version" of
      PrEP SMART (mSMART; Mobile App based Personalized Solutions and Tools for Medication
      Adherence of Rx Pill) platform in another clinical context.

      The primary aim of this study is to conduct a proof-of-concept trial of PrEP SMART.

        -  Aim 1a: User interaction with the app will allow for evaluation of feasibility (e.g.,
           the number of app uses/day)

        -  Aim 1b: Acceptability will be assessed via self-report ratings and qualitative
           interviewing

        -  Aim 1c: Medication adherence will be evaluated via daily smartphone camera-based
           medication event assessments to establish preliminary data on the impact of mSMART for
           future efficacy trials.

        -  Aim 1d: Adherence barriers will be evaluated by mSMART following missed doses.
    

Intervention name(s): PrEP Smart
Intervention type(s): Behavioral
Intervention description(s): Men who have sex with men and already prescribed and taking oral PrEP will use an application on their smart phone for 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment