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

NCT03916484 | Completed Results

• 2 other identifiers: 18-20611R34MH118058-01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Mean Percent of Past 30-Day ART Medication Adherence

  Month 6 follow-up time point

• Mean Percent ART Medication Adherence Over Time

  up to 6 months

• Number of Participants With Viral Suppression

  Month 6 follow-up time point

• Percent of Participants With Viral Suppression Over Time

  up to 3 months

• Percent of Participants With Viral Suppression Over Time

  up to 6 months

Study Arms (4)

AQ HIV Medication Adherence app-delivered intervention

EXPERIMENTAL

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 HIV Medication Adherence app-delivered intervention + NSC

EXPERIMENTAL

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

AQ followed by AQ+NSC

EXPERIMENTAL

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

AQ+NSC followed by AQ

EXPERIMENTAL

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

Interventions

AllyQuest HIV Medication Adherence app-delivered intervention BEHAVIORAL

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.

Also known as: AQ

AQ HIV Medication Adherence app-delivered intervention; AQ followed by AQ+NSC; AQ+NSC followed by AQ

AllyQuest HIV Medication Adherence app-delivered intervention + NSC BEHAVIORAL

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.

Also known as: AQ+

AQ HIV Medication Adherence app-delivered intervention + NSC; AQ followed by AQ+NSC; AQ+NSC followed by AQ

Eligibility Criteria

• Age: 15 Years - 29 Years
• Gender Eligibility Details: The study will enroll self identified men and transgender women.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator
• Medical University of South Carolina: collaborator
• Wayne State University: collaborator
• Rutgers University: collaborator
• University of Alabama at Birmingham: collaborator
• North Carolina State University: collaborator

Study Sites (6)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

RAIN

Charlotte, North Carolina, 28201, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Sexual Behavior; Sexually Transmitted Diseases; Hepatitis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Kate Muessig, PhD
• Organization: University of North Carolina at Chapel Hill

kmuessig@fsu.edu

850-644-3299

Study Officials

• Kate Muessig, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lisa Hightow-Weidman, MD, MPH

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: July 8, 2020
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)