Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina:...

Area of Science:

• Public Health
• Epidemiology
• Digital Health Interventions

Background:

• HIV prevention disparities persist in the US South, with North Carolina showing low pre-exposure prophylaxis (PrEP) uptake among young, sexual, and gender minority populations.
• The PrEP-to-need ratio highlights significant inequities, with underserved groups like women and Black, Hispanic, and Southern individuals having lower access relative to HIV incidence.
• Limited healthcare infrastructure and the concentration of PrEP services in urban STI clinics create barriers to HIV prevention in rural areas.

Purpose of the Study:

• To describe a randomized controlled trial protocol for a multilevel PrEP intervention.
• To address disparities in PrEP uptake within rural and periurban settings in North Carolina.

Main Methods:

• A randomized controlled trial enrolling 336 participants, assigned 1:1 to an intervention or control group.
• The intervention includes a digital health app, remote PrEP navigator linkage, and telehealth options; the control group receives enhanced standard care.
• Primary outcome is PrEP initiation within 3 months; secondary outcomes include care engagement, adherence, incident infections, stigma, and cost-effectiveness.

Main Results:

• Enrollment began in August 2023 across 15 NC health departments, expanding to 21 facilities by July 2024.
• Data collection is anticipated to conclude by May 2025, with results to be published thereafter.
• The study is registered on ClinicalTrials.gov (NCT05984030).

Conclusions:

• This study directly addresses barriers to PrEP use in underserved rural and periurban areas of the Southeastern US.
• Findings can inform policy and programming to expand PrEP access and promote its use in communities facing HIV disparities.
• The intervention aims to improve PrEP equity and reduce HIV incidence in vulnerable populations.