Avatar-based Mobile Phone Intervention for Medication Adherence and Retention in Care

Overseen By Mark S Dworkin, MD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: ART

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

295 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Mark Dworkin, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for African American men who have sex with men (AAMSM), aged 18-34, who own smartphones and are prescribed antiretroviral therapy (ART). They must either be starting ART or already on it, have a detectable viral load in the past month, or have adherence issues. Those who can't participate include non-English speakers, those without upcoming clinic appointments, or anyone involved in earlier app testing phases.

Inclusion Criteria

Have a viral load detectable within the past 4 weeks or self-reported or provider-reported history of adherence or treatment engagement problems.

You can start or continue taking antiretroviral therapy (ART) during the study.

Self-reported African American MSM

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 month

Baseline Monitoring

Baseline ART adherence is monitored wirelessly for 1 month

1 month

Intervention

Participants use the My Personal Health Guide Avatar application or control app for adherence and retention in care

6 months

Monthly data collection

Follow-up

Participants are monitored for ART adherence, viral load, and retention in care

2 months

What Are the Treatments Tested in This Trial?

Interventions

• My Personal Food Guide
• My Personal Health Guide

Trial Overview 'My Personal Health Guide' is an Avatar-based mobile phone app designed to help HIV-positive AAMSM stick to their treatment and stay engaged in care by providing information and support through a private platform. The study will assess how effective this innovative tool is at overcoming barriers like stigma.

How Is the Trial Designed?

Group I: Control app Experimental Treatment 1 Intervention

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 II: Avatar intervention app Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Ruth M. Rothstein CORE Center

Collaborator

Trials

11

Recruited

2,800+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+