Integrating Supports to Promote PrEP for Black Adolescents Working With Apps

NCT ID: NCT06876324

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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 Alabama, where AYAs (ages 13-24) account for 31% 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 Alabama as a geographic hotspot, emphasizing the need for patient-centered interventions to reduce HIV incidence.

Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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 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

Group Type EXPERIMENTAL

HealthMPowerment App

Intervention Type BEHAVIORAL

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

Interventions

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HealthMPowerment App

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* HIV positive
* Inability to provide informed consent
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Samantha Hill

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samantha Hill, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Samantha Hill, MD, MPH

Role: CONTACT

404-778-1537

Stephanie Wallace, MD, MPH

Role: CONTACT

(205) 638-9345

Facility Contacts

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Stephenie Wallace, MD

Role: primary

(205) 638-9345

Other Identifiers

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7K23MH128128-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007320

Identifier Type: -

Identifier Source: org_study_id

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