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

NCT ID: NCT04217174

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-04
• Study Completion Date: 2025-03-30

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.

Detailed Description

This proposal focuses on an innovative theory-driven intervention aimed at helping to improve outcomes for AAMSM targeting 3 stages of the HIV Care Continuum, (1) retention, (2) adherence to antiretroviral medication, and (3) viral suppression. My Personal Health Guide is an innovative talking relational human Avatar mobile phone application to engage HIV-positive AAMSM in adherence and retention in care. Development of this app was informed by the Information Motivation Behavioral Skills Model that focuses on feedback between information and motivation that affect one's behavioral skills, behaviors, and desired health outcomes. In the privacy of the user's home or anywhere they have their phone, 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 their caregivers. As part of a collaboration between UIC, Emory University, and the University of Mississippi Medical Center, the investigators propose to test the efficacy of the My Personal Health Guide Avatar application for young HIV-positive AAMSM. In this study, 250 HIV-positive AAMSM between the ages of 18-34 years with detectable viral load at baseline will be randomized to the My Personal Health Guide Avatar application or a food safety Avatar application control intervention for a 6-month period. Wirelessly monitored ART adherence will be collected for 1-month at baseline and then wirelessly monitored ART adherence, viral load, and clinic appointment data will be collected throughout the 6-month follow-up period. The investigators hypothesize that participants in the My Personal Health Guide intervention will demonstrate significant improvements in ART adherence, viral load, and retention in care during the follow-up period compared to control participants. The investigators will also identify mobile phone application functions that are associated with improvement in adherence in order to inform refinement of the application. The investigators hypothesize that more frequent use of Avatar information functions that included motivational messages will be associated with improved ART adherence.

Conditions

Medication Adherence; Retention in Care

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Avatar intervention app

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.

Group Type: EXPERIMENTAL

My Personal Health Guide

Intervention Type: 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.

Control app

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.

Group Type: OTHER

My Personal Food Guide

Intervention Type: 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.

Interventions

My Personal Health Guide

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.

Intervention Type: BEHAVIORAL

My Personal Food Guide

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Self-reported African American MSM
• 18 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Ruth M. Rothstein CORE Center

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Mark S Dworkin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Dworkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30742481 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30064971 (View on PubMed)

Other Identifiers

R01MH116721

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-1184

Identifier Type: -

Identifier Source: org_study_id