AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial
Condition: Hiv; HIV/AIDS; Medication Adherence; Sexual Behavior; Sexually Transmitted Infections (Not HIV or Hepatitis)
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication
      adherence for young men who have sex with men and young transgender women who have sex with
      men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims
      to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence
      counseling in a Sequential Multiple Assignment Randomization Trial.
    

Detailed description: 
      AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication
      adherence for young men who have sex with men and young transgender women who have sex with
      men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims
      to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence
      counseling in a Sequential Multiple Assignment Randomization Trial.

      AllyQuest (AQ) is a smart phone application for Android and iOS (Apple) that supports HIV
      medication adherence. Intervention development was guided by health behavior change theories
      including Social Cognitive Theory (SCT), narrative communication (e.g. storytelling), and the
      Fogg Behavioral Model (FBM) of persuasive technology. AQ addresses key principles of SCT
      including: (1) observational learning by doing daily activities; (2) modeling and vicarious
      experiences (observing and participating in Daily Discussions, exploration of narrative
      "choose-your-own-adventure" stories); (3) self-efficacy and verbal persuasion from expert
      sources (multi-media knowledge center, tailored messages) and (4) reinforcements (virtual
      rewards, financial incentives, achievements). AQ incorporates principles of the FBM including
      triggers via app notifications and content, increasing ability via knowledge articles and
      identifying steps toward behavioral goals, and motivation via social support, rewards, goal
      setting, and achievement.

      This study will test AQ and an enhanced version of AQ (AQ+) that adds two-way text based Next
      Step Counseling (NSC) for medication adherence. A sequential multiple assignment randomized
      trial (SMART) is a study design suited to development of adaptive interventions. An adaptive
      intervention is a sequence of decision rules that specify how the intensity or type of
      treatment should change depending on the patient's needs rather than applying a "one size
      fits all" approach. In a SMART, participants are randomized to an initial treatment, and,
      depending on how they respond, may be assigned or randomized to a new type or intensity of
      treatment. SMARTs are an efficient and rigorous way to study how the type or dose of
      treatment should be adjusted based on subject characteristics or response and thus maximize
      clinical utility and real-world applicability. In this SMART, participants are initially
      randomized to medication adherence support with one of two intervention approaches (AQ or
      AQ+NSC). At 3 months, based on protocol defined intervention responsiveness, participants are
      re-randomized or reassigned to continue their initial intervention approach or to change to
      the other intervention approach for months 4 - 6 of the trial.

      Participants will complete viral load (VL) and web-based computer assisted survey instrument
      (CASI) assessments at baseline and 3- and 6- months. A sample of 20-25 users will complete a
      qualitative exit interview to evaluate their experience using AQ and AQ+ and their experience
      with the escalation/de-escalation intervention strategies.

      The study will assess intervention feasibility, acceptability, and preliminary efficacy
      including: 1) frequency and total time spent on each AQ feature; 2) in-app daily adherence
      reports; and 3) user-contributed content (adherence counseling chat logs, user-entered daily
      discussion content and adherence strategies). Analyses will determine which treatment
      strategies embedded in the SMART (escalation, de-escalation, and maintenance combinations)
      result in sustained intervention app engagement, self-reported adherence, and viral
      suppression.
    

Intervention name(s): AllyQuest HIV Medication Adherence app-delivered intervention; AllyQuest HIV Medication Adherence app-delivered intervention + NSC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.; In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
Other intervention name(s): AQ; AQ+
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential multiple assignment randomized trials (SMART) are adaptive interventions. An adaptive intervention is a sequence of decision rules that specify how the intensity or type of treatment should change depending on the patient's needs rather than applying a "one size fits all" approach. The type or dose of the intervention is adjusted based on participant characteristics or response. SMARTs are an efficient and rigorous way to maximize clinical utility and real-world applicability. In this SMART, participants are initially randomized to medication adherence support with one of two intervention approaches (AQ or AQ+NSC). At 3 months, based on protocol defined intervention responsiveness, participants are re-randomized or reassigned to continue their initial intervention approach or to change to the other intervention approach for months 4 - 6 of the trial.
Masking: None (Open Label)
Primary purpose: Supportive Care