Integrating Supports to Promote PrEP for Black Adolescents Working With Apps- Alabama
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HealthMPowerment App.
- Who it may be relevant to
- Registry conditions: HIV. Basic parameters: 14 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adolescent SPEAKS Study: Integrating Supports to Promote PrEP for Black Adolescents Working With Apps
Overview
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
- Behavioral HealthMPowerment App
A mobile health app designed to facilitate increased PrEP use and adherence among AYAs
Primary outcome measures
- Acceptability/Usability [Time frame: 1 month, 3 months, and 6 months]
- Feasibility: Communication [Time frame: 1 month, 3 months, and 6 months]
Secondary outcome measures (2)
- Medication Adherence Tracker [Time frame: 1 month, 3 months, and 6 months]
- Data Usage [Time frame: 1 month, 3 months, and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Alabama — Birmingham
Identifiers
NCT: NCT06876324 · STUDY00007320 · 7K23MH128128-03 · 2024P007023