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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03916484
1R34MH118058-01 (U.S. NIH Grant/Contract)
18-2061

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

Male

Ages

15 to 29 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

71 participants in 4 patient groups

AQ HIV Medication Adherence app-delivered intervention
Experimental group
Description:
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.
Treatment:
Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention
AQ HIV Medication Adherence app-delivered intervention + NSC
Experimental group
Description:
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.
Treatment:
Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC
AQ followed by AQ+NSC
Experimental group
Description:
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.
Treatment:
Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention
Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC
AQ+NSC followed by AQ
Experimental group
Description:
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.
Treatment:
Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention
Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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