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AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial (AQ2)

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ClinicalTrials.gov Identifier: NCT03916484
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : July 24, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Medical University of South Carolina
Wayne State University
Rutgers University
University of Alabama at Birmingham
North Carolina State University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Hiv HIV/AIDS Medication Adherence Sexual Behavior Sexually Transmitted Infections (Not HIV or Hepatitis) Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: AllyQuest mHealth Intervention to Optimize HIV Medication Adherence and Care Among HIV-positive Young Men Who Have Sex With Men and Transgender Women: Pilot Sequential Multiple-Assignment Randomization Trial (SMART)
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AQ HIV Medication Adherence app-delivered intervention
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
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.
Other Name: AQ

Experimental: AQ HIV Medication Adherence app-delivered intervention + NSC
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
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 Name: AQ+

Experimental: AQ followed by AQ+NSC
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
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.
Other Name: AQ

Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC
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 Name: AQ+

Experimental: AQ+NSC followed by AQ
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
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.
Other Name: AQ

Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC
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 Name: AQ+




Primary Outcome Measures :
  1. Intervention feasibility: Average proportion of days of any app use [ Time Frame: 6 Months ]
    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.

  2. Intervention feasibility: Average proportion of days of HIV medication tracked [ Time Frame: 6 Months ]
    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.

  3. Intervention acceptability: Mean intervention acceptability, composite score CSQ-8 [ Time Frame: 6 Months ]
    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).


Secondary Outcome Measures :
  1. Change in ART medication adherence from Baseline to Month 6 [ Time Frame: Baseline, Month 6 follow-up time point ]
    ART Medication Adherence is measured by CASI as number of missed ART doses in the past 30 days. The study will compare the average number of missed doses reported on the baseline CASI with average number of missed doses reported on the month 6 follow-up CASI time point.

  2. Difference in ART medication adherence between treatment arms at Month 6 [ Time Frame: Month 6 follow-up time point ]
    ART Medication Adherence is measured by CASI as number of missed ART doses in the past 30 days. The difference in number of missed doses as reported on the 6-month follow-up CASI will be compared across the study's treatment arms.

  3. Rate of viral suppression at 6-month follow-up [ Time Frame: Month 6 follow-up time point ]
    Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. The study will report the proportion of participants who are virally suppressed at 6 month follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study will enroll self identified men and transgender women.
Accepts Healthy Volunteers:   No
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 24
  • assigned female at birth
  • HIV negative or status unknown

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916484


Contacts
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Contact: Kelly Knudtson, MPH (919) 962 4640 knudtson@med.unc.edu
Contact: Kate Muessig, PhD (919) 962-5059 kate_muessig@med.unc.edu

Locations
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United States, North Carolina
UNC-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Knudtson, MPH    919-962-4640    knudtson@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Medical University of South Carolina
Wayne State University
Rutgers University
University of Alabama at Birmingham
North Carolina State University
Investigators
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Principal Investigator: Kate Muessig, PhD UNC-Chapel Hill
Principal Investigator: Lisa Hightow-Weidman, MD, MPH UNC-Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03916484    
Other Study ID Numbers: 18-2061
1R34MH118058-01 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases
Infection