Clinical trial NCT03916484: AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial
Official title: Piloting a Sequential Multiple-Assignment Randomization Trial to Evaluate AllyQuest: an mHealth Intervention for HIV-positive Young MSM and TWSM to Optimize HIV Medication Adherence and Care Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
HIV/AIDS
Medication Adherence
Sexual Behavior
Sexually Transmitted Infections (Not HIV or Hepatitis)
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Medical University of South Carolina
name: Wayne State University
name: Rutgers University
name: University of Alabama at Birmingham
name: North Carolina State University
First posted: 2019-04-16
Enrollment: 71
Sex: MALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Living with HIV
* Assigned male at birth
* currently identify as male or transgender woman
* anal sex with another male or transgender woman(lifetime)
* access to a smart phone with data plan
* English literacy
* prescribed ART
* At least one of the following: Having failed to show up for or missed 1 or more scheduled HIV care appointment in the past 12 months OR Last HIV care visit was more than 6 months ago OR Self-reporting less than 90% ART adherence in the past 4 weeks OR have a detectable viral load measure in the past 12 months OR recently diagnosed with HIV (past 3 months)

Exclusion Criteria:

* younger than 15, or older than 29
* assigned female at birth
* HIV negative or status unknown

Primary outcomes:
measure: Intervention Feasibility: Average Proportion of Days of Any App Use
timeFrame: 180 days
measure: Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked
timeFrame: 180 Days
measure: Intervention Acceptability: Mean Intervention Acceptability CSQ-8 Score
timeFrame: 6 Months
measure: Intervention Acceptability: Mean Intervention Acceptability Score
timeFrame: 6 Months
Secondary outcomes:
measure: Mean Percent of Past 30-Day ART Medication Adherence
timeFrame: Month 6 follow-up time point
measure: Mean Percent ART Medication Adherence Over Time
timeFrame: up to 6 months
measure: Number of Participants With Viral Suppression
timeFrame: Month 6 follow-up time point
measure: Percent of Participants With Viral Suppression Over Time
timeFrame: up to 3 months
measure: Percent of Participants With Viral Suppression Over Time
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: RAIN
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Kate Muessig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC-Chapel Hill
name: Lisa Hightow-Weidman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: