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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06876324
Enrollment
10
Registered
2025-03-14
Start date
2026-08-01
Completion date
2027-08-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Medication Adherence, PrEP

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.

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.

Interventions

BEHAVIORALHealthMPowerment App

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

Sponsors

Emory University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability/Usability1 month, 3 months, and 6 monthsThe 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.
Feasibility: Communication1 month, 3 months, and 6 monthsCommunication 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

MeasureTime frameDescription
Medication Adherence Tracker1 month, 3 months, and 6 monthsThis 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)
Data Usage1 month, 3 months, and 6 monthsThis 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)

Countries

United States

Contacts

CONTACTSamantha Hill, MD, MPH
svhill2@emory.edu404-778-1537
CONTACTStephanie Wallace, MD, MPH
stepheni@uab.edu(205) 638-9345
PRINCIPAL_INVESTIGATORSamantha Hill, MD, MPH

Emory University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026