Clinical trial NCT04217174: An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM
Official title: A Mobile Phone Intervention Using a Relational Human Talking Avatar to Promote Multiple Stages of the HIV Care Continuum in African American MSM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medication Adherence
Retention in Care
Keywords: HIV
adherence
retention in care
avatar
mobile phone application
food safety
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Mississippi Medical Center
name: Emory University
name: Ruth M. Rothstein CORE Center
First posted: 2020-01-03
Enrollment: 295
Sex: MALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Viral suppression
timeFrame: From study enrollment until 2 months after study conclusion (9 months).
Secondary outcomes:
measure: Antiretroviral therapy adherence
timeFrame: 6 months before enrollment through two months after study conclusion (15 months).
measure: Retention in care
timeFrame: From app installation until study conclusion (6 months).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Mark Dworkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.