Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217174
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : March 13, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Mississippi Medical Center
Emory University
Ruth M. Rothstein CORE Center
Information provided by (Responsible Party):
Mark S Dworkin, 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.

Condition or disease Intervention/treatment Phase
Medication Adherence Retention in Care Behavioral: My Personal Health Guide Behavioral: My Personal Food Guide Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Avatar intervention app
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.
Behavioral: My Personal Health Guide
My Personal Health Guide is a theory-based mobile phone app that uses an Avatar as a personal health guide to increase patient knowledge of HIV disease and its complications and rationale for healthy behavior, increase self-efficacy and motivate participants to improve retention in care and medication adherence, and explain and illustrate behavioral skills related to retention in care, and adherence, with a result of improved behavior that leads to personal and population benefits through viral suppression and decreased risk of transmission, respectively. The relational aspect of the Avatar may be a powerful supplement to clinical care. 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 caregivers.

Control app
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.
Behavioral: My Personal Food Guide
My Personal Food Guide is a mobile phone app that contains a talking realistic avatar who teaches about food safety, sugar content in selected foods, and some other food related information. The avatar motivates safe food behavior in order reduce the likelihood of food poisoning and promotes a healthy diet.




Primary Outcome Measures :
  1. Viral suppression [ Time Frame: 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 :
  1. Antiretroviral therapy adherence [ Time Frame: 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.

  2. Retention in care [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This is a study of men who have sex with men so it is male gender based. Participants will self-report as male gender.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217174


Contacts
Layout table for location contacts
Contact: Mark S Dworkin, MD 3124130348 mdworkin@uic.edu
Contact: Anita Shapherd, MPH 3123554667 anshap@uic.edu

Locations
Layout table for location information
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Mark Dworkin, MD    312-413-0348    mdworkin@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Mental Health (NIMH)
University of Mississippi Medical Center
Emory University
Ruth M. Rothstein CORE Center
Publications:
Layout table for additonal information
Responsible Party: Mark S Dworkin, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04217174    
Other Study ID Numbers: 2019-1184
R01MH116721 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing will depend on the nature of the request, available resources to fulfill the request, and IRB restrictions.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark S Dworkin, University of Illinois at Chicago:
HIV
adherence
retention in care
avatar
mobile phone application
food safety