Epic Allies HIV ART Adherence Intervention
Condition: HIV
Study type: Interventional

Summary: 
      This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability,
      impact, and long-term sustainability of the Epic Allies intervention application (app), a
      theory-based mobile app that utilizes game mechanics and social networking features to
      improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral
      suppression among HIV-positive young men who have sex with men (YMSM) and trans women who
      have sex with men. Subjects will be randomized to either the intervention branch of the Epic
      Allies app or the control branch of the app.
    

Detailed description: 
      Implementation of effective interventions for HIV care engagement is necessary to raise the
      percentage of people living with HIV/Acquired Immunodeficiency Syndrome (AIDS) who are
      virally suppressed and in continuous care. The ultimate goal of this study is to assess the
      effectiveness of a mobile phone app that utilizes game mechanics and social networking
      features to improve engagement in care, and ART uptake and adherence among HIV-positive YMSM
      and trans women who have sex with men. The high mobile phone ownership among adolescent and
      young adults supports using intervention tools based in these familiar available
      technologies. If successful, Epic Allies would be clinically attractive, as adherent patients
      would require less frequent clinic visits and experience fewer HIV-related secondary
      infections and financially attractive, as reducing clinic visits and secondary infections.
      Epic Allies could also greatly impact public health as ART adherence reduces HIV infectivity
      and subsequently reduces HIV transmission.

      This is a two-arm randomized-controlled trial (RCT). All subjects will be randomized either
      to the intervention arm and receive the Epic Allies intervention branch of the app or to the
      control arm and receive the phone-based notifications only control branch of the app.
      Randomization will occur in a 1:1 ratio within each of the two groups (new-to-care and
      ART-non-adherent) separately, with an equal number of subjects in the intervention and
      control arms. During the 26-week intervention phase, intervention arm subjects will receive
      the daily adherence reminders they set up through Epic Allies with tailored feedback for
      encouragement and reinforcement. Intervention arm subjects will have 24-hour access to all
      features of Epic Allies. The control arm subjects will receive weekly phone-based
      notifications to encourage them to view educational information presented in the app.
      Subjects will attend study visits at Week 13 (during intervention phase), Week 26 (end of
      intervention phase), and Week 39 (post-intervention phase). In-depth qualitative app
      satisfaction interviews with a subset of intervention arm subjects will also be conducted to
      evaluate acceptability of the app and its potential to improve engagement in care, uptake of
      ART, and ART adherence. Outcome measures will include engagement in care, ART uptake, ART
      adherence, viral load (VL) change, and VL suppression. The in-depth qualitative app
      satisfaction interview will assess intervention impact, acceptability, and long-term
      sustainability.
    

Intervention name(s): Epic Allies App Intervention; Epic Allies - Control Branch
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Epic Allies app addresses barriers to ART adherence through:
Users track health progress through an interactive dashboard, logging daily adherence for those on ART and, optionally, exercise, smoking, alcohol and drug use, and mood. Those not on ART will rate how close they are to getting on it.
Users pick medication reminder timing. The app sends weekly messages to users based on adherence progress and other tracked behaviors.
A key part of the app is contact between users to foster a setting that supports norms for medication-taking, reducing stigma related to HIV status and ART use. Users send and receive encouragement to spur behavior change, recognize positive behaviors, and inspire others to reach an adherence goal.
Users progress through Epic Allies' virtual world, creating allies with other users.
The Daily Dose newspaper has content to improve HIV/ART knowledge, promote disease management and increase drive and self-efficacy.; Subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: HIV; YMSM; Trans women; ART Adherence; Intervention