Supporting Tailored And Responsive PrEP in Rural North Carolina

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 HIV Pre-Exposure Prophylaxis

🗓️ Study Start (Actual) 31 August 2023

🗓️ Primary Completion (Estimated) 30 June 2025

✅ Study Completion (Estimated) 30 June 2025

👥 Enrollment (Estimated) 336

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Assigned male sex at birth
* Report sexual activity with a male in the past 12 months
* Received HIV testing within 90 days pre-enrollment and not known to be HIV-positive at screening/enrollment by self-report
* Age 18-39 years
* Have daily smartphone access
* Be English speaking
* Deny current PrEP use

Exclusion Criteria:

* Confirmed prior HIV-positive diagnosis
* Prior PrEP use (oral PrEP or injectable PrEP) within the last 3 months.

Ages Eligible for Study: 18 Years to 39 Years (ADULT)

Sexes Eligible for Study: MALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 1 August 2023
First Submitted that Met QC Criteria 1 August 2023
First Posted 9 August 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 2 October 2023
Last Update Posted 4 October 2023
Last Verified July 2023