Clinical trial NCT06876324: Integrating Supports to Promote PrEP for Black Adolescents Working With Apps
Official title: Adolescent SPEAKS Study: Integrating Supports to Promote PrEP for Black Adolescents Working With Apps
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Keywords: Medication Adherence
PrEP
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-14
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Acceptability/Usability
timeFrame: 1 month, 3 months, and 6 months
measure: Feasibility: Communication
timeFrame: 1 month, 3 months, and 6 months
Secondary outcomes:
measure: Medication Adherence Tracker
timeFrame: 1 month, 3 months, and 6 months
measure: Data Usage
timeFrame: 1 month, 3 months, and 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: Emory University
name: Samantha Hill, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: