An Avatar-based Mobile Phone Intervention to Promote Health in African American MSM
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|ClinicalTrials.gov Identifier: NCT04217174|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : May 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence Retention in Care||Behavioral: My Personal Health Guide Behavioral: My Personal Food Guide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||295 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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.
- 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.
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
|Contact: Mark S Dworkin, MDfirstname.lastname@example.org|
|Contact: Anita Shapherd, MPHemail@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Mark Dworkin, MD 312-413-0348 firstname.lastname@example.org|
|Principal Investigator:||Mark Dworkin, MD||University of Illinois at Chicago|