Supporting Tailored And Responsive PrEP in Rural North Carolina (STARR-NC)

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Pre-Exposure Prophylaxis

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05984030

22-3058

R61AI174285 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

STARR NC Intervention Condition

Experimental group

Description:

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.

Treatment:

Behavioral: HealthMpowerment Digital Health Intervention - Enhanced

Other: PrEP Navigation Services

Other: Telehealth PrEP Services Referral

STARR NC Standard-of-Care Control Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: HealthMpowerment Digital Health Intervention - Basic