CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
PrEP Navigation Services +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05984030
NCT05984030N/ACompleted

Meet me Where I am: A Multilevel Strategy to Increase PrEP Uptake and Persistence in Rural NC

University of North Carolina, Chapel Hill·interventional·Posted Aug 9, 2023·Updated Aug 15, 2025

In Brief

A clinical study evaluating PrEP Navigation Services, Telehealth PrEP Services Referral, and 2 other interventions for HIV Pre-Exposure Prophylaxis. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedAug 9, 2023
Enrollment StartAug 31, 2023
Primary CompletionMay 2, 2025
Study CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 2.9 years ago

Interventions

PrEP Navigation Servicesother

Trained professional PrEP navigators will connect with intervention arm participants following study onboarding. Primary navigator responsibilities include helping participants engage in PrEP care, assisting with completing necessary paperwork for insurance, referral to PrEP care, and application for drug assistance programs, as needed. Navigation services will be available to participants for the first 6 months of participation (active intervention period). Navigation services are tailored to the individual needs of each intervention arm participant

Telehealth PrEP Services Referralother

PrEP Navigators can link interested intervention arm participants to telehealth PrEP services via self-referral. The study facilitates referral for intervention arm participants to pre-existing telehealth PrEP services. The telehealth PrEP services participants receive are not provided, financed, or staffed by the study. Participants will receive telehealth PrEP services via the technology platform or service that the provider typically employs. PrEP clinical eligibility, visit frequency, monitoring labs, and all other PrEP management will be at the discretion of the established PrEP provider. PrEP navigators can assist with appointment scheduling, reminders, and other provider-access issues, as requested, for the first 6 months of study participation.

HealthMpowerment Digital Health Intervention - Enhancedbehavioral

The Enhanced version of the HealthMpowerment Digital Health Intervention includes all features from the Basic version, plus the following additional features: Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement.

HealthMpowerment Digital Health Intervention - Basicbehavioral

The Control Arm version of the HealthMpowerment Digital Health Intervention includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center.