Supporting Tailored and Responsive PrEP in Rural North Carolina (STARR NC)
STARR NC is a study to increase the uptake of PrEP (pre-exposure prophylaxis), medication that prevents HIV, within populations of young sexual minority men who reside in rural counties in North Carolina. STARR NC will enroll 336 participants between the ages of 18-39 in North Carolina over the span of 18 months.
Overview
STARR NC will collaborate with local, rural STI clinics in order to increase the uptake in PrEP amongst young sexual minority men (YSMM). This project consists of two phases to be completed over five years. The Phase 1 study is a randomized trial of a multilevel PrEP intervention strategy in rural NC sexually transmitted infection (STI) clinics, with primary outcome of PrEP uptake within 3 months of an index STI clinic visit.
Participants will be randomized 1:1 to an intervention or control condition. Participants enrolled in the intervention arm will receive a multi-level 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 in a given clinic setting. They will also receive linkage to a limited version of the DHI, with basic PrEP resources and information.
Aim 1
This aim will capture participants’ PrEP use history, sexual behaviors, demographics, and determinants of PrEP use (access to care, perceived HIV risk, social support, perceived discrimination, mental health, substance use, and PrEP decision making). All participants will complete an onboarding appointment where they consent to participate, download the study app and receive a tour, complete their baseline CASI survey, and intervention arm participants are connected to their PrEP navigator.
Aim 2
We will build a decision model to estimate and compare the budget impact, cost-effectiveness, and population outcomes of our multilevel PrEP intervention. We will model the value of each component (PrEP navigator, HMP app, telehealth provider) as assessed in Aim 1, separately and in combination. We will examine the impact of alternative combinations via sensitivity analyses, varying assumptions about the costs and combined effectiveness of the interventions. We will further parameterize the model and conduct sensitivity analyses using published PrEP cost and effectiveness data.
We will directly measure costs and a surrogate marker of HIV prevention effectiveness (PrEP uptake) in our RCT. Our analysis presumes that increasing uptake of PrEP is a desired outcome, focusing our assessment on incremental HD related intervention costs. Following established methods, we will measure non-research related costs associated with the intervention and control arms to estimate incremental cost per additional person starting PrEP. Analyses will take the perspective of the HD and public payers.
Aim 3
Engage state and local stakeholders to refine PrEP intervention, tailored to unique contextual needs using Intervention Mapping. We will use Intervention Mapping (IM) to refine our PrEP intervention. Grounded in community participatory research, IM emphasizes matching an intervention with population needs and intervention context; as such, it is well-suited for translating the effectiveness, implementation, and cost-effectiveness outcomes collected in Aims 1 & 2 to the proposed expansion in Aim 4.
Each IM step includes processes for documentation. The steps are iterative, and matrices, objectives, and outcomes are revisited, revised, and expanded as involved parties gain new knowledge about the population, determinants, and context. As such, record-keeping at each step is detailed and includes decision logs and formal reports following each step and the conclusion of the process. At the conclusion of Aim 3, the refined PrEP intervention will be ready for use in all clinics.
Aim 4
Determine effectiveness and cost-effectiveness of refined PrEP implementation strategy, expanded to all participants.