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

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

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: HIV
• Intervention / Treatment: Behavioral: HealthMPowerment App

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Hill, MD, MPH; Phone Number: 404-778-1537; Email: svhill2@emory.edu
• Study Contact Backup: Name: Stephanie Wallace, MD, MPH; Phone Number: (205) 638-9345; Email: stepheni@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 25294-0111
      • University of Alabama
      • Contact: Stephenie Wallace, MD; Phone Number: (205) 638-9345; Email: stepheni@uab.edu
      • Sub-Investigator: Stephanie Wallace, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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 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; 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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence Tracker	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	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

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Samantha Hill, MD, MPH, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; Medication Adherence
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Medication Adherence
• Other Study ID Numbers: STUDY00007320; 7K23MH128128-03 (U.S. NIH Grant/Contract); 2024P007023 (Other Identifier: Emory IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results in the article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; 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
• product manufactured in and exported from the U.S.: No