Clinical trial NCT05984030: Supporting Tailored And Responsive PrEP in Rural North Carolina
Official title: Meet me Where I am: A Multilevel Strategy to Increase PrEP Uptake and Persistence in Rural NC
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Pre-Exposure Prophylaxis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-08-09
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants reporting PrEP initiation by 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of participants reporting PrEP initiation by 6 months
timeFrame: 6 months
measure: Proportion of PrEP initiators adhering to chosen PrEP strategy over first 3 months
timeFrame: 3 months
measure: Proportion of PrEP initiators adhering to chosen PrEP strategy over first 6 months
timeFrame: 6 months
measure: Average number of consecutive months PrEP used over first 3 months
timeFrame: 3 months
measure: Average number of consecutive months PrEP used over first 6 months
timeFrame: 6 months
measure: Average number of days PrEP used among persons initiating daily oral PrEP in the 30 days prior to the 3-month visit.
timeFrame: 3 months
measure: Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 3-month visit.
timeFrame: 3-months
measure: Proportion of injectable PrEP initiators reporting PrEP use in the 90 days prior to the 3-month visit
timeFrame: 3 months
measure: Average number of days PrEP used among persons initiating daily oral PrEP in the 30 days prior to the 6-month visit.
timeFrame: 6 months
measure: Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 6-month visit.
timeFrame: 6 months
measure: Proportion of injectable PrEP initiators reporting PrEP use in the 90 days prior to the 6-month visit
timeFrame: 6 months
measure: Proportion of oral PrEP initiators with detected PrEP concentrations in blood at 3 months
timeFrame: 3 months
measure: Proportion of oral PrEP initiators with detected PrEP concentrations in blood at 6 months
timeFrame: 6 months
measure: Proportion of injectable PrEP initiators receiving all prescribed injections through 3 months
timeFrame: 3 months
measure: Proportion of injectable PrEP initiators receiving all prescribed injections through 6 months
timeFrame: 6 months
measure: Proportion of participants who test positive for HIV among those tested at or prior to the 3-month visit
timeFrame: 3 months
measure: Proportion of participants who test positive for HIV among those tested at or prior to the 6-month visit
timeFrame: 6 months
measure: Proportion of participants who test positive for an STI other than HIV among those tested at or prior to the 3-month visit
timeFrame: 3 months
measure: Proportion of participants who test positive for an STI other than HIV among those tested at or prior to the 6-month visit
timeFrame: 6 months
measure: Average self-reported score on the PrEP Stigma scale at 3 months
timeFrame: 3 months
measure: Average self-reported score on the PrEP Stigma scale at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Sarah Rutstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: