Supporting Tailored And Responsive PrEP in Rural North Carolina

NCT05984030 | Completed Results DMC

• 2 other identifiers: 22-3058R61AI174285
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Reporting PrEP Initiation by 3 Months

  Proportion of participants with verified self-reported pre-exposure prophylaxis (PrEP) use (first dose, oral or injectable PrEP)1 at or before 3 months, defined as the number verified to start PrEP divided by the total number of participants in each arm

  3 months

Secondary Outcomes (21)

• Proportion of Participants Reporting PrEP Initiation by 6 Months

  6 months

• Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 3 Months

  3 months

• Proportion of PrEP Initiators Adhering to Chosen PrEP Strategy Over First 6 Months

  6 months

• Average Number of Consecutive Months PrEP Used Over First 3 Months

  3 months

• Average Number of Consecutive Months PrEP Used Over First 6 Months

  6 months

Study Arms (2)

STARR NC Intervention Condition

EXPERIMENTAL

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); and referral to Telehealth PrEP services as an option for linking to PrEP care. The Intervention Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center; 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. Intervention Arm participants will complete baseline and quarterly follow-up assessments. Intervention Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

Other: PrEP Navigation Services; Other: Telehealth PrEP Services Referral; Behavioral: HealthMpowerment Digital Health Intervention - Enhanced

STARR NC Standard-of-Care Control Condition

ACTIVE COMPARATOR

Standard-of-Care Control arm will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive study staff guided support to install the control arm version of the HealthMPowerment DHI platform. The Control Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center. Control Arm participants will complete baseline and quarterly follow-up assessments. Control Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

Behavioral: HealthMpowerment Digital Health Intervention - Basic

Interventions

PrEP Navigation Services OTHER

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

STARR NC Intervention Condition

Telehealth PrEP Services Referral OTHER

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.

STARR NC Intervention Condition

HealthMpowerment Digital Health Intervention - Enhanced BEHAVIORAL

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.

STARR NC Intervention Condition

HealthMpowerment Digital Health Intervention - Basic BEHAVIORAL

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.

STARR NC Standard-of-Care Control Condition

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: Participants assigned female at birth must identify as cisgender to be eligible for participation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Rutstein SE, Ferguson E, Mansour O, Brown N, Stocks JB, Washington A, Mobley V, Dowler S, Edwards J, Hightow-Weidman LB, Hurt CB, Pence B, Muessig KE. Multilevel Intervention to Support Tailored and Responsive HIV Pre-Exposure Prophylaxis Care in Rural North Carolina: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 21;14:e68085. doi: 10.2196/68085.

  PMID: 40117579 DERIVED

Results Point of Contact

• Title: Sarah Rutstein, MD, PhD
• Organization: UNC Institute for Global Health and Infectious Diseases

sarah_rutstein@med.unc.edu

919-966-2537

Study Officials

• Sarah Rutstein, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 to Intervention Condition or Control Condition. The study will use blocked randomization stratified by county, with randomly ordered blocks of sizes 4 and 6. Depending on their date of enrollment, participants will be asked to complete baseline and quarterly assessments at 3, 6, and 12-month follow-ups. Primary outcome measures are assessed at month 3. Secondary outcome measures are assessed at months 3 and 6.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: August 31, 2023
• Primary Completion: May 2, 2025
• Study Completion: June 1, 2025
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following publication of primary study results.
• Access Criteria: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (1)