An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM
- Conditions
- Retention in CareMedication Adherence
- Interventions
- Behavioral: My Personal Food GuideBehavioral: My Personal Health Guide
- Registration Number
- NCT04217174
- Lead Sponsor
- University of Illinois at Chicago
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 295
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control app My Personal Food Guide 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. Avatar intervention app My Personal Health Guide 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.
- Primary Outcome Measures
Name Time Method Viral suppression From study enrollment until 2 months after study conclusion (9 months). 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.
- Secondary Outcome Measures
Name Time Method Antiretroviral therapy adherence 6 months before enrollment through two months after study conclusion (15 months). The investigators will use the Wisepill real-time electronic monitoring adherence device. The device obtains daily adherence information that can be analyzed as 7 monthly adherence measurements (1 month baseline and 6 months follow-up) calculated as proportion of doses taken out of days in the month. To supplement this measure, in the follow-up questionnaire the investigators will also collect the number of missed doses during the past month by self-report.
Retention in care From app installation until study conclusion (6 months). To measure retention in care, the investigators will query participant's medical record to determine the number of HIV-related visits during the 6-months of follow-up.
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States