An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM

NCT04217174 | Completed DMC

• 2 other identifiers: 2019-1184R01MH116721
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to determine the efficacy of "My Personal Health Guide," a theory-based innovative talking relational human Avatar mobile phone application to engage HIV-positive AAMSM in adherence and retention in care. Providing an empathetic talking Avatar source of HIV-related information, motivation, and behavioral skills that is as private and convenient as their own mobile phone might produce a high impact by overcoming barriers to HIV adherence and retention in care such as stigma and health literacy.

Conditions

Retention in Care; Medication Adherence

Keywords

HIV; adherence; retention in care; avatar; mobile phone application; food safety

Outcome Measures

Primary Outcomes (1)

• Viral suppression

  The investigators will review medical records for HIV viral load measurements including the detectable measurement at study entry and all measurements that occur during the 6 months of follow-up and 2 months after. To ensure a high proportion of subjects have a follow-up viral load for comparison to their study entry viral load, the investigators will collect a fingerprick dried blood spot for viral load at the follow-up interview.

  From study enrollment until 2 months after study conclusion (9 months).

Secondary Outcomes (2)

• Antiretroviral therapy adherence

  6 months before enrollment through two months after study conclusion (15 months).

• Retention in care

  From app installation until study conclusion (6 months).

Study Arms (2)

Avatar intervention app

EXPERIMENTAL

The intervention is a mobile phone app that features a realistic talking human avatar who promotes adherence to ART and retention in care, motivates, and provides information and opportunities for HIV care-related behavioral skills.

Behavioral: My Personal Health Guide

Control app

OTHER

The control app is a mobile phone app that features a realistic talking human avatar who primarily promotes food safety and also offers knowledge of sugar content in food. This app is expected to have no effect on ART adherence and retention in care, however, it has never been tested to determine if it may have any effect so it has been categorized as Other (arm type) rather than as placebo.

Behavioral: My Personal Food Guide

Interventions

My Personal Health Guide BEHAVIORAL

My Personal Health Guide is a theory-based mobile phone app that uses an Avatar as a personal health guide to increase patient knowledge of HIV disease and its complications and rationale for healthy behavior, increase self-efficacy and motivate participants to improve retention in care and medication adherence, and explain and illustrate behavioral skills related to retention in care, and adherence, with a result of improved behavior that leads to personal and population benefits through viral suppression and decreased risk of transmission, respectively. The relational aspect of the Avatar may be a powerful supplement to clinical care. The Avatar can encourage healthy behavior, acknowledge stigma and speak with empathy, audibly teach persons with low literacy, employ credible culturally appropriate phrasing, and invite the user to hear advice and motivational stories of other HIV-positive people and caregivers.

Avatar intervention app

My Personal Food Guide BEHAVIORAL

My Personal Food Guide is a mobile phone app that contains a talking realistic avatar who teaches about food safety, sugar content in selected foods, and some other food related information. The avatar motivates safe food behavior in order reduce the likelihood of food poisoning and promotes a healthy diet.

Control app

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: This is a study of men who have sex with men so it is male gender based. Participants will self-report as male gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Self-reported African American MSM
• to 34 years old
• Smartphone owners
• Prescribed ART
• Have a viral load detectable within the past 4 weeks or self-reported or provider-reported history of adherence or treatment engagement problems.
• Participants may be initiating ART or already on ART.

You may not qualify if:

• Cannot speak English
• Decline to participate
• Participated in the usability and Beta testing phase of the app refinement that preceded this RCT
• Do not have a routine clinic appointment scheduled during the observation time.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Mississippi Medical Center: collaborator
• Emory University: collaborator
• Ruth M. Rothstein CORE Center: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• Dworkin MS, Lee S, Chakraborty A, Monahan C, Hightow-Weidman L, Garofalo R, Qato DM, Liu L, Jimenez A. Acceptability, Feasibility, and Preliminary Efficacy of a Theory-Based Relational Embodied Conversational Agent Mobile Phone Intervention to Promote HIV Medication Adherence in Young HIV-Positive African American MSM. AIDS Educ Prev. 2019 Feb;31(1):17-37. doi: 10.1521/aeap.2019.31.1.17.

  PMID: 30742481 BACKGROUND

• Dworkin M, Chakraborty A, Lee S, Monahan C, Hightow-Weidman L, Garofalo R, Qato D, Jimenez A. A Realistic Talking Human Embodied Agent Mobile Phone Intervention to Promote HIV Medication Adherence and Retention in Care in Young HIV-Positive African American Men Who Have Sex With Men: Qualitative Study. JMIR Mhealth Uhealth. 2018 Jul 31;6(7):e10211. doi: 10.2196/10211.

  PMID: 30064971 BACKGROUND

• Dworkin MS, Herrera K, Upton S, Luc CM, Jones J, Liu L, Jimenez A, Burns P, Ren R, Lee S, Woody M, Garofalo R. Evidence of Efficacy of the My Personal Health Guide Mobile Phone App on Antiretroviral Therapy Adherence Among Young African American Men Who Have Sex With Men at 1 Month: Randomized Controlled Trial. JMIR Mhealth Uhealth 2026;14:e75005. URL: https://mhealth.jmir.org/2026/1/e75005/ doi: 10.2196/75005

  RESULT

• Dworkin MS, Herrera K, Upton S, Luc CM, Jones J, Burns P, Liu L, Jimenez A, Ren R, Woody M, Garofalo R, Lee S. Evidence of Efficacy of the My Personal Health Guide Mobile Phone App on Antiretroviral Therapy Adherence Among Young African American Men Who Have Sex With Men at 1 Month: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Feb 3;14:e75005. doi: 10.2196/75005.

  PMID: 41632958 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mark Dworkin, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: March 4, 2020
• Primary Completion: May 31, 2024
• Study Completion: November 30, 2024
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication in a peer-reviewed journal of the results of the three study aims, depending on the nature of the request, available resources to fulfill the request, and IRB restrictions, a dataset of deidentified data could be made available, estimated June 2025
• Access Criteria: Request of PI with rationale.

Locations

US (1)