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

NCT06876324 | Not Yet Recruiting DMC

• 3 other identifiers: STUDY000073207K23MH128128-032024P007023
• 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

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 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: HealthMPowerment App

Interventions

HealthMPowerment 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 the state of Alabama
• 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:
• \>21 years old
• 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 informed consent

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Alabama

Birmingham, Alabama, 25294-0111, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

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; svhill2@emory.edu

Stephanie Wallace, MD, MPH

CONTACT

(205) 638-9345; stepheni@uab.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: March 10, 2025
• First Posted: March 14, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Proposals should be directed to svhill2@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data are delivered electronically to investigators.

Locations

US (1)