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Clinical Trial Summary

This project consists of two phases to be completed over five years. Phase 1 (Aims 1 and 2) will be completed during Years 1-3 (R61). The Phase 1 study is a randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina sexually transmitted infection (STI) clinics, with primary outcome of PrEP uptake within 3 months of an index STI clinic visit.


Clinical Trial Description

Participants will be randomized 1:1 to an intervention or control condition. Participants enrolled in the intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment) - a HIPAA-compliant evidence-based DHI that provides interactive educational resources, social support, and tools for developing PrEP behavioral skills and self-efficacy; and referral to Telehealth PrEP services as an option for linking to PrEP care. Control arm participants will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive linkage to a limited version of the DHI, with basic PrEP resources and information. ;


Study Design


NCT number NCT05984030
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact Sarah E Rutstein, MD, PhD
Phone 919-966-2537
Email srutstein@unc.edu
Status Recruiting
Phase N/A
Start date August 31, 2023
Completion date June 30, 2025