JMIR Publications

ABSTRACT

Background:

While access to pre-exposure prophylaxis (PrEP) is an important tool for reducing HIV incidence in the United States (US), disparities in uptake by race, sex, socioeconomic status, and geography persist. In North Carolina (NC), PrEP uptake is lowest among young sexual and gender minority men (YSGM), despite this key population accounting for the majority of new infections, especially in rural areas. Sexually transmitted infection (STI) clinics are a logical point of entry to PrEP care; integrating linkage to PrEP within rural and peri-urban STI clinics extends access to this underserved community. This protocol describes a randomized trial of a multilevel PrEP intervention, recruiting from rural and peri-urban STI clinics.

Objective:

The purpose of this study is to test new ways to increase access to PrEP for people in North Carolina. The study includes an intervention that tests whether providing access to resources related to PrEP care at clinics that already offer HIV or sexually transmitted infection (STI) services will increase the number of people who start using PrEP.

Methods:

The trial aims to enroll up to 336 participants and randomize them 1:1 to either intervention or control. The intervention consists of access to a digital health app, linkage to a remote PrEP navigator, and the option for referral to telehealth-based PrEP services. Persons randomized to the control condition will receive an enhanced standard of care, including access to a limited version of the digital health app. All participants will be followed quarterly for at least 3 months. The primary outcome is the initiation of PrEP within 3 months of an index STI clinic visit; secondary outcomes evaluate PrEP care engagement and adherence, incident HIV/STI infections, PrEP stigma, and cost-effectiveness.

Results:

Enrollment opened on August 31, 2023 at 15 Health Departments in North Carolina and subsequently expanded to 21 facilities in 20 counties by July 2024. Recruitment is ongoing, with the expected completion of the enrollment and data collection phase in May 2025. Results to be published thereafter.

Conclusions:

The study directly addresses multiple barriers to PrEP utilization in rural and peri-urban areas of the Southeastern US and can inform policy and programming that seeks to expand PrEP access and promote use in underserved communities. Clinical Trial: Registered at clinicaltrials.gov (# NCT05984030)