AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hiv, HIV/AIDS, Medication Adherence, Sexual Behavior, Sexually Transmitted Infections (Not HIV or Hepatitis)

Intervention / Treatment
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* Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention
* Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AQ HIV Medication Adherence app-delivered intervention<br>AQ: At minimum, intended app usage (dose) is for participant to complete a set of activities (record medication taking, complete a challenge, complete a forum post) one time per day (frequency) for 6 months (duration). The participant may or may not stay solely on AQ throughout the study. | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention<br>* 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.<br>* Other names: AQ;|
| Experimental: AQ HIV Medication Adherence app-delivered intervention + NSC<br>AQ+NSC: At minimum, intended app usage (dose) is for participant to complete a set of activities (record medication taking, complete a challenge, complete a forum post) one time per day (frequency) for 6 months (duration). NSC sessions are scheduled approximately every other week (frequency) and last approximately 30 minutes per session (dose). The participant may or may not stay on AQ+NSC throughout the study. | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC<br>* 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.<br>* Other names: AQ+;|
| Experimental: AQ followed by AQ+NSC<br>At 3 months, those who were initially randomized to AQ who meet protocol defined definition for intervention non-responsiveness, are reassigned to AQ+NSC to complete months 4 - 6 of the trial. | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention<br>* 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.<br>* Other names: AQ;Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC<br>* 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.<br>* Other names: AQ+;|
| Experimental: AQ+NSC followed by AQ<br>At 3 months, those who were initially randomized to AQ+NSC who meet protocol defined definition for intervention responsiveness, may get re-randomized to AQ alone to complete months 4 - 6 of the trial. | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention<br>* 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.<br>* Other names: AQ;Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC<br>* 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.<br>* Other names: AQ+;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Feasibility: Average Proportion of Days of Any App Use | The average proportion of days of any app use during the trial across all participants as recorded by the app backend para data. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | 180 days | 
| Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | The average proportion of days participants used the app to track their HIV medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | 180 Days | 
| Intervention Acceptability: Mean Intervention Acceptability CSQ-8 Score | The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome). | 6 Months | 
| Intervention Acceptability: Mean Intervention Acceptability Score | The mean composite score is calculated from the Acceptability of Health Apps among Adolescents (AHAA) scale, a 22-item validated scale measuring the construct of global intervention acceptability. Item response options include: Strongly Disagree, Disagree, Agree, Strongly Agree. Scale items are grouped into 6 sub-scales. Responses to the items in each sub-scale are averaged and the sub-scale averages are added to obtain a total possible composite score ranging from 6 (lowest acceptability, worst outcome) to 24 (highest acceptable, best outcome). A score of 18 or higher is consistent with overall high acceptability. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of Past 30-Day ART Medication Adherence | HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of ART doses taken in the past 30 days. | Month 6 follow-up time point | 
| Mean Percent ART Medication Adherence Over Time | HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of prescribed ART doses taken in the past 30 days. Assessed at Baseline and Month 6 follow-up time point. | up to 6 months | 
| Number of Participants With Viral Suppression | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. The study will report the number of participants who are virally suppressed at 6 month follow-up. | Month 6 follow-up time point | 
| Percent of Participants With Viral Suppression Over Time | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 3 follow-up time point. | up to 3 months | 
| Percent of Participants With Viral Suppression Over Time | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 6 follow-up. | up to 6 months |