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

NCT07535346 | Not Yet Recruiting DMC

• 1 other identifier: 2025P010539
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

medication adherence; PrEP

Outcome Measures

Primary Outcomes (2)

• Acceptability/Usability

  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

  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 Outcomes (2)

• Medication Adherence Tracker

  1 month, 3 months, and 6 months

• Data Usage

  1 month, 3 months, and 6 months

Study Arms (1)

AYA group

EXPERIMENTAL

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

Interventions

Health MPowerment App BEHAVIORAL

A mobile health app designed to facilitate increased PrEP use and adherence among AYAs

AYA group

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• HIV positive Inability to provide consent

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

HIV Infections; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Samantha Hill, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Hill, MD, MPH

CONTACT

404-778-1537; samantha.veronica.hill@emory.edu

Jacob Aiello, MPH

CONTACT

404-712-9344; jacob.aiello@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: AYAs will be paired with an adult who has identified as a support person and will use the app to facilitate dyadic communication to improve PrEP use among Black AYAs. Participants will be enrolled for 6 months. All participants will participate in the intervention

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: May 2027 onwards

Locations

US (1)