Supporting Tailored And Responsive PrEP in Rural North Carolina

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.

Conditions

• HIV Pre-Exposure Prophylaxis

Interventions

OTHER

PrEP Navigation Services

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

OTHER

Telehealth PrEP Services Referral

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.

BEHAVIORAL

HealthMpowerment Digital Health Intervention - Enhanced

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.

BEHAVIORAL

HealthMpowerment Digital Health Intervention - Basic

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Sarah Rutstein, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-31

Primary Completion

2025-05-02

Completion

2025-06-01

Countries

• United States

Study Locations