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

University of Illinois

Status: Active, not recruiting

Conditions: Medication Adherence; Retention in Care

Treatments: Behavioral: My Personal Food Guide; Behavioral: My Personal Health Guide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04217174

R01MH116721 (U.S. NIH Grant/Contract)

2019-1184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 295 estimated patients

Sex: Male

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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295 participants in 2 patient groups

Avatar intervention app

Experimental group

Description:

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.

Treatment:

Behavioral: My Personal Health Guide

Control app

Other group

Description:

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.

Treatment:

Behavioral: My Personal Food Guide