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NCT Number: NCT06876324

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

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.

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Key information

Conditions

HIV Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama

Birmingham, Alabama, 25294-0111, United States

Location contact

Stephanie Wallace, MD

SUB_INVESTIGATOR

Stephenie Wallace, MD

CONTACT

[email protected]

(205) 638-9345

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HealthMPowerment App

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Hill, MD, MPH

CONTACT

[email protected]

404-778-1537

Stephanie Wallace, MD, MPH

CONTACT

[email protected]

(205) 638-9345

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Adolescent SPEAKS Study: Integrating Supports to Promote PrEP for Black Adolescents Working With Apps

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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