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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile phone app designed to help African American men who have sex with men (AAMSM) manage their HIV treatment more effectively. The app features a talking avatar that provides support and information about medication adherence and maintaining doctor visits. The researchers aim to determine if this app offers more benefits than a standard app focused on food safety, such as "My Personal Food Guide" or "My Personal Health Guide." AAMSM who own a smartphone and have experienced difficulty adhering to HIV medication or attending doctor visits may be well-suited for this trial.

As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could improve HIV treatment management for AAMSM.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. It seems to focus on helping you stick to your HIV treatment, so you likely won't need to stop your current meds.

What prior data suggests that this mobile phone intervention is safe for users?

Research shows that the avatar-based mobile phone app helps people follow their HIV treatment plan. A talking avatar provides information and encouragement. Studies have found that similar digital tools can make users feel comfortable, helping them discuss their health without awkwardness.

No reports of risks or side effects have emerged from using this type of app. Since it mainly provides information and motivation through a phone, it appears to be a safe support tool for managing HIV care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the avatar-based mobile phone intervention for medication adherence and retention in HIV care because it offers a novel way to engage patients. Unlike traditional methods, which often rely on direct healthcare provider interaction, this app uses a realistic talking human avatar to promote adherence to antiretroviral therapy (ART) and retention in care. This innovative approach leverages technology to motivate and provide personalized information, potentially enhancing patient engagement and improving health outcomes. Additionally, the app's ability to deliver behavioral skills training directly to a mobile device makes it a convenient and accessible option for users.

What evidence suggests that the Avatar intervention app is effective for improving medication adherence and retention in care for HIV-positive individuals?

Research has shown that the "My Personal Health Guide" app, featuring a talking avatar, can help people adhere to their HIV treatment and remain in care. In this trial, participants in the experimental arm will use the Avatar intervention app, which includes a lifelike talking avatar to enhance adherence to antiretroviral therapy (ART) by providing motivation and key information. The app makes HIV care more private and convenient, addressing challenges like stigma and low health literacy. Early results suggest that regular use of the app's motivational messages may improve medication adherence. This app aims to make managing HIV treatment easier and more engaging for users. ^{1 2 3 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04217174?cond=care%20in&viewType=Table&checkSpell=&rank=4

An Avatar-based Mobile Phone Intervention to Promote ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6092590/

A Realistic Talking Human Embodied Agent Mobile Phone ... This study aimed to develop a theory-driven talking avatar-like embodied agent mobile phone intervention guided by the information-motivation-behavioral skills ...

3. grantome.com grantome.com/grant/NIH/R01-MH116721-03

A mobile phone intervention using a relational human ... We hypothesize that more frequent use of Avatar information functions that included motivational messages will be associated with improved ART adherence. ... If ...

4. researchgate.net researchgate.net/publication/325801404_Development_of_a_theory-based_relational_realistic_talking_human_embodied_agent_mobile_phone_intervention_to_promote_HIV_medication_adherence_and_retention_in_care_in_young_HIV-positive_African_Americ

Development of a theory-based relational realistic talking ... Objective: This study aimed to develop a theory-driven talking avatar-like embodied agent mobile phone intervention guided by the information-motivation- ...

5. ctv.veeva.com ctv.veeva.com/study/an-avatar-based-mobile-phone-intervention-to-promote-health-in-african-american-msm

An Avatar-based Mobile Phone Intervention to Promote Health ... The intervention is a mobile phone app that features a realistic talking human avatar who promotes adherence to ART and retention in care, ...

6. europepmc.org europepmc.org/article/med/37492122

Virtual avatars as a new tool for human immunodeficiency ... Avatar technology was found to create a comfortable environment for participants to address and discuss their sexual behaviors with less hesitation.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11905588/

The role of digital tools in enhancing antiretroviral therapy ... Digital tools show potential in improving ART adherence among AYA living with HIV. Although only two studies reported statistically significant improvement in ...