NIH grant: The Women's PrEP Project (W-PrEP): A cluster randomized controlled trial of a clinic-level intervention to improve HIV prevention services for women (1R01NR022623-01A1)

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NIH grant 1R01NR022623-01A1: The Women's PrEP Project (W-PrEP): A cluster randomized controlled trial of a clinic-level intervention to improve HIV prevention services for women
Institute: {'code': 'NR', 'abbreviation': 'NINR', 'name': 'National Institute of Nursing Research', 'admin_org_id': '12500052', 'admin_funding_url': ''}. PI: Manya  Magnus. Award: $827567.
Start: 2026-09-25T00:00:00.
PROJECT SUMMARY
Women account for nearly one-fifth of new HIV diagnoses in the United States (US); public health efforts for
HIV prevention for women fall notably short. The Centers for Disease Control (CDC) estimates that only 10%
of women who would benefit from biomedical HIV prevention are prescribed pre-exposure prophylaxis (PrEP).
There are significant social and structural barriers to PrEP use by women, including lack of provider
awareness, medical mistrust, cost, and lack of access. Given the dearth of evidence-based interventions to
improve PrEP initiation, adherence, and persistence among women in the US, through a National Institute of
Mental Health award (R34MH128046, PI: Scott) we iteratively adapted two CDC-designated Best Practice HIV-
prevention interventions to create the clinic-level intervention to promote universal provision of PrEP education,
counseling, and services for women, to be tested in this study. The adapted socio-structural intervention, “the
Women’s PrEP Project” (W-PrEP) is designed to increase engagement and retention in the PrEP cascade
among women through improved provision of PrEP services by the clinic team. W-PrEP integrates clinic-wide
trainings to educate clinicians and staff about PrEP and HIV prevention, optimize best prescribing practices,
and positively reframe HIV prevention as part of patient-centered care, along with PrEP toolkits, and patient-
facing materials and resources. W-PrEP integrates a codified PrEP peer navigation program to address socio-
structural barriers to PrEP initiation, adherence, and continuation/persistence. To examine the potential impact
of this novel intervention, we will conduct a hybrid type 2 effectiveness-implementation trial to evaluate the
impact of the W-PrEP intervention with a multi-center, cluster randomized controlled trial of six health clinics in
geographically-similar designated ending the HIV epidemic (EHE) jurisdictions. We will examine
implementation using the Practical, Robust, Implementation, & Sustainability Model (PRISM) framework.
Specific Aims are to assess Effectiveness; Reach and Adoption; Implementation; and Maintenance. Findings
from this study will provide novel and scalable clinic-based methods to improve HIV prevention among women
in the US in geographic areas with high HIV incidence.

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