- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217174
An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM
December 1, 2022 updated by: Mark S Dworkin, University of Illinois at Chicago
A Mobile Phone Intervention Using a Relational Human Talking Avatar to Promote Multiple Stages of the HIV Care Continuum in African American MSM
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
295
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mark S Dworkin, MD
- Phone Number: 3124130348
- Email: mdworkin@uic.edu
Study Contact Backup
- Name: Anita Shapherd, MPH
- Phone Number: 3123554667
- Email: anshap@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois at Chicago
-
Contact:
- Mark Dworkin, MD
- Phone Number: 312-413-0348
- Email: mdworkin@uic.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From study enrollment until 2 months after study conclusion (9 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months before enrollment through two months after study conclusion (15 months).
|
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.
|
From app installation until study conclusion (6 months).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark Dworkin, MD, University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 4, 2020
Primary Completion (ANTICIPATED)
July 31, 2023
Study Completion (ANTICIPATED)
November 30, 2023
Study Registration Dates
First Submitted
December 31, 2019
First Submitted That Met QC Criteria
December 31, 2019
First Posted (ACTUAL)
January 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2022
Last Update Submitted That Met QC Criteria
December 1, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2019-1184
- R01MH116721 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data sharing will depend on the nature of the request, available resources to fulfill the request, and IRB restrictions.
IPD Sharing Time Frame
After publication in a peer-reviewed journal of the results of the three study aims, depending on the nature of the request, available resources to fulfill the request, and IRB restrictions, a dataset of deidentified data could be made available, estimated June 2025
IPD Sharing Access Criteria
Request of PI with rationale.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Medication Adherence
-
NYU Langone HealthRobert Wood Johnson Foundation; New York City Health and Hospitals CorporationCompletedMedication Adherence | Medication ErrorsUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingMedication Adherence | Medication ComplianceUnited States
-
Vanderbilt University Medical CenterCompletedAdherence, Medication | Nonadherence, MedicationUnited States
-
Universidad Autonoma de Baja CaliforniaCompletedMedication Adherence | Medication ComplianceMexico
-
Universiti Putra MalaysiaCompletedMedication Adherence | Adherence, TreatmentPakistan
-
University Hospital, Basel, SwitzerlandUniversity of BaselCompletedPolymedication-Check With Insight in Patients' Medication Organisation and Comprehension of GenericsMedication Adherence | Medication Therapy ManagementSwitzerland
-
Cliniques universitaires Saint-Luc- Université...RecruitingAdherence, MedicationBelgium
-
Northwell HealthNational Institute on Aging (NIA)RecruitingMedication AdherenceUnited States
-
Swedish Medical CenterNational Institute of Mental Health (NIMH); University of Washington; University...Recruiting
-
Northwell HealthToronto Dominion BankCompletedMedication AdherenceUnited States
Clinical Trials on My Personal Health Guide
-
McGill UniversityCanadian Institutes of Health Research (CIHR); CIHR Canadian HIV Trials NetworkUnknownChronic Disease | GoalsCanada
-
Northwestern UniversityCompletedQuality of Life | Stress, Emotional | Cancer-related Problem/ConditionUnited States
-
Northwestern UniversityCompletedQuality of Life | Stress, Emotional | Cancer-related Problem/ConditionUnited States
-
Eastern Mediterranean UniversityRecruitingBreast Feeding | Self Efficacy | AttachmentCyprus
-
Northwestern UniversityNational Cancer Institute (NCI); University of MiamiRecruitingCancer | Anxiety | Depressive SymptomsUnited States
-
Northwestern UniversityCompletedQuality of Life | Adherence, Medication | Cancer, Breast | Cancer-related Problem/Condition | Hormone Dependent NeoplasmsUnited States
-
VA Office of Research and DevelopmentCompletedDiabetes MellitusUnited States
-
Baptist Health South FloridaCompletedObesity | Cardiovascular Disease | Atherosclerosis | Metabolic SyndromeUnited States
-
Cedars-Sinai Medical CenterUniversity of Michigan; NestléCompleted
-
NYU Langone HealthNew York City Department of Health and Mental HygieneCompleted