Integrating Supports to Promote PrEP for Black Adolescents Working With Apps- Atlanta

April 10, 2026 updated by: Samantha Hill, Emory University

Discrete Choice Experiments for HIV Prevention in Atlanta Adolescents- Atlanta

This study applies Social Cognitive Theory to develop behavioral interventions promoting PrEP adherence. It seeks to adapt and test the enhanced HMP app for feasibility and acceptability among Black adolescents and young adults (AYAs) and adult supports.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

HIV pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV infections, reducing the risk by over 90%. However, adherence among AYAs remains suboptimal, with only 34% maintaining adherence at 48 weeks. Studies suggest that adult support can improve adherence in pediatric HIV treatment, but this approach has not been systematically evaluated for PrEP use in AYAs. Prior research indicates that Black AYAs and their families are open to incorporating adult support for PrEP adherence. Given the success of mobile health (mHealth) interventions in promoting sexual health, this study aims to enhance the HealthMPowerment (HMP) app-an existing mHealth platform designed for HIV prevention-to facilitate dyadic communication between Black AYAs and trusted adult support persons.

The study addresses the high rates of HIV among Black adolescents and young adults (AYAs) in metro Atlanta, Georgia, where AYAs (ages 13-24) account for 21% of new HIV diagnoses, with Black gay and bisexual males, transgender individuals, and heterosexual young women being disproportionately affected. Nearly half of new infections occur in rural areas. The U.S. Department of Health and Human Services Ending the HIV Epidemic initiative prioritizes four counties in metro Atlanta (Cobb, DeKalb, Fulton, and Gwinnett) as geographic hotspots, emphasizing the need for patient-centered interventions to reduce HIV incidence.

Study Type

Interventional

Enrollment (Estimated)

10

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

Study Contact Backup

Study Locations

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • African Americans
  • Living in metropolitan Atlanta counties- Cobb, DeKalb, Fulton, Gwinnett
  • Have a PrEP indication (e.g., sex with a partner living with HIV, condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months)
  • Support Person:
  • self-reported provision of instrumental, informational, or emotional support for a Black AYA 14-21 years old

Exclusion Criteria:

HIV positive Inability to provide consent

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AYA group

All enrolled participants (AYAs and support persons) will receive a demonstration of the app, including all of its features. All participants will use the app for 6 months. Each dyad of participants will be instructed to use the app to communicate with each other and AYAs will be instructed to use the app to keep track of their PrEP.

Data from the medication tracker will be collected at 1-,

3-, and 6-months
Behavioral: Health MPowerment App
A mobile health app designed to facilitate increased PrEP use and adherence among AYAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability/Usability
Time Frame: 1 month, 3 months, and 6 months
The study evaluates an app's impact through post-intervention interviews, focusing on user experience, ethical concerns, and future usage intentions. It explores burden, satisfaction, attitudes, and how the app influences communication and adherence. Sekhon's Theoretical Framework of Acceptability will be utilized to measure this outcome.
1 month, 3 months, and 6 months
Feasibility: Communication
Time Frame: 1 month, 3 months, and 6 months
Communication between adolescents and young adults (AYA) and support person (i.e., Experience using chat features; Experience using forums). A modified version of Structured Assessment of FEasibility (SAFE) will be utilized to measure this outcome.
1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence Tracker
Time Frame: 1 month, 3 months, and 6 months
This will be measured by analyzing the percent of dates with data entered into the medication tracker and correlating that data with reasons why participants did not take their medication (when applicable)
1 month, 3 months, and 6 months
Data Usage
Time Frame: 1 month, 3 months, and 6 months
This will be measured by comparing the amount of time (minutes) spent using distinct features of the app (e.g. forums, educational resources, avatars, side effect trackers, chat features)
1 month, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Samantha Hill, MD, MPH, Emory University

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P010539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The following data will be shared: Data acceptability and feasibility measures as analyzed via interviews and surveys, and data app usage

IPD Sharing Time Frame

May 2027 onwards

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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.

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