Epic Allies HIV ART Adherence Intervention

NCT02782130 | Completed

• 2 other identifiers: ATN 1325R44MH102096-03
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 5

Brief Summary

This is a two-arm, randomized-controlled trial (RCT) that will test the acceptability, impact, and long-term sustainability of the Epic Allies intervention application (app), a theory-based mobile app that utilizes game mechanics and social networking features to improve engagement in care, antiretroviral therapy (ART) uptake, ART adherence, and viral suppression among HIV-positive young men who have sex with men (YMSM) and trans women who have sex with men. Subjects will be randomized to either the intervention branch of the Epic Allies app or the control branch of the app.

Conditions

HIV

Keywords

HIV; YMSM; Trans women; ART Adherence; Intervention

Outcome Measures

Primary Outcomes (2)

• VL suppression at 13 weeks

  VL suppression at 13 weeks is defined as VL below the lower limit of detection (LLD) in the six-week window before the Week 13 visit.

  13 weeks

• VL suppression at 26 weeks

  VL suppression at 26 weeks is defined as VL below the lower limit of detection (LLD) in the six-week window before the Week 26 visit.

  26 weeks

Secondary Outcomes (3)

• Self-reported ART adherence

  13 weeks, 26 weeks, and 39 weeks

• Retention in HIV Care

  13 weeks, 26 weeks, and 39 weeks

• VL suppression at 39 weeks

  39 weeks

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Subjects randomized to the Epic Allies Intervention will download and install the intervention branch of the Epic Allies app and receive a tour of the app guided by site staff. During the 26-week intervention phase, intervention arm subjects will receive daily adherence reminders set up through Epic Allies with tailored feedback for encouragement and reinforcement. Intervention arm subjects will have 24-hour access to all features of Epic Allies and will receive supportive messages from other subjects on the intervention arm.

Behavioral: Epic Allies App Intervention

Control Group

PLACEBO COMPARATOR

Subjects randomized to the control arm will download and install the control branch of the Epic Allies app (phone-based notifications only) and be provided with instructions on using the app. During the 26-week intervention phase, the control arm subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.

Behavioral: Epic Allies - Control Branch

Interventions

Epic Allies App Intervention BEHAVIORAL

The Epic Allies app addresses barriers to ART adherence through: 1. Users track health progress through an interactive dashboard, logging daily adherence for those on ART and, optionally, exercise, smoking, alcohol and drug use, and mood. Those not on ART will rate how close they are to getting on it. 2. Users pick medication reminder timing. The app sends weekly messages to users based on adherence progress and other tracked behaviors. 3. A key part of the app is contact between users to foster a setting that supports norms for medication-taking, reducing stigma related to HIV status and ART use. Users send and receive encouragement to spur behavior change, recognize positive behaviors, and inspire others to reach an adherence goal. 4. Users progress through Epic Allies' virtual world, creating allies with other users. 5. The Daily Dose newspaper has content to improve HIV/ART knowledge, promote disease management and increase drive and self-efficacy.

Intervention Group

Epic Allies - Control Branch BEHAVIORAL

Subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.

Control Group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• To be considered eligible for enrollment, an individual must meet all the criteria listed below.
• Ages 16 years and 0 days through 24 years and 364 days, inclusive, at the time of signed informed consent or assent with parental/legal guardian permission, if applicable;
• Assigned male sex at birth, is of any gender identity, and self-reports a desire to engage or is engaging in sex with men;
• Has documentation of a VL collected within the 12 weeks prior to the Baseline visit that is greater than the LLD for the assay used to test the specimen;
• Be either:
• New-to-care: Newly entered HIV medical care within the 12 months prior to the Baseline visit; or
• ART-non-adherent: First entered HIV medical care more than 12 months prior to the Baseline visit;
• Has reliable daily access to an Android- or iOS-based smartphone with a data plan;
• Is able to speak and read English;
• Is willing and able to provide signed informed consent or assent; and
• Parent or legal guardian is willing to provide permission, if applicable.

You may not qualify if:

• To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
• Presence of active serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individual's ability to provide true informed consent/assent or complete the baseline CAPI survey\*;
• Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior) at the time of consent/assent or the baseline CAPI survey\*;
• Intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the ability to give true informed/assent is impaired\*; or
• At the time of the baseline CAPI survey, intoxicated or under the influence of alcohol or other substances to such an extent that in the opinion of the study staff, the subject's ability to understand and answer the questions may be impaired or negatively impact the integrity of the research data\*.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

University of South Florida

Tampa, Florida, 33606, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (2)

• Hightow-Weidman L, Muessig KE, Egger JR, Vecchio A, Platt A. Epic Allies: A Gamified Mobile App to Improve Engagement in HIV Care and Antiretroviral Adherence among Young Men Who have Sex with Men. AIDS Behav. 2021 Aug;25(8):2599-2617. doi: 10.1007/s10461-021-03222-y. Epub 2021 Mar 19.

  PMID: 33740213 DERIVED

• LeGrand S, Muessig KE, Platt A, Soni K, Egger JR, Nwoko N, McNulty T, Hightow-Weidman LB. Epic Allies, a Gamified Mobile Phone App to Improve Engagement in Care, Antiretroviral Uptake, and Adherence Among Young Men Who Have Sex With Men and Young Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 5;7(4):e94. doi: 10.2196/resprot.8811.

  PMID: 29622527 DERIVED

Study Officials

• Lisa Hightow-Weidman, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: May 25, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 14, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

US (5)