"The Women's PrEP Project," a Clinic-Based, Socio-Structural Intervention to Improve the Provision of Preexposure Prophylaxis for Cisgender Women: Interrupted Time Series Pilot.

Background: Cisgender women account for 23% of new HIV diagnoses in the United States, but there are significant socio-structural barriers to engagement and retention in the preexposure prophylaxis (PrEP) cascade, particularly for women of color. Objective: In response to the lack of evidence-based interventions to improve PrEP initiation, adherence, and persistence among women in the United States, we developed and piloted a clinic-based, socio-structural intervention to measure (1) the feasibility of delivering the adapted intervention and (2) clinic team and patient perspectives on the intervention, in preparation for a future trial on engagement and retention in the PrEP cascade among women. Methods: We previously applied the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, Testing) model to develop a culturally appropriate, evidence-based intervention, responsive to Black women's HIV prevention needs. In the present study, we set out to complete the Training and Testing phases: namely, to hire and train a PrEP navigator and to train clinic staff to deliver the adapted intervention. We completed a 4-month pilot to assess the feasibility of delivering the intervention and collecting outcomes of interest and initial outcome trends (compared to baseline). We further assessed the clinic team and patient perspectives on the intervention to understand the potential for future scale and delivery. Results: The clinic team participants found the adapted Women's PrEP project (W-PrEP) intervention both highly feasible and relevant to patients, with minimal impact on clinic flow. Patient participants reported that the W-PrEP intervention was highly relevant and appreciated the education and counseling from the PrEP navigator-many learning about PrEP for the first time from the navigator and health care provider. The outcome measures were both feasible to collect and appropriate to capture the primary outcomes of interest. Finally, the W-PrEP intervention increased the proportion of patients counseled about PrEP from 65% to 76% of patients seen (P<.001). Conclusions: The intervention and outcome data collection was feasible, and open-ended clinic team and patient perspectives showed positive feedback about the intervention and relevance. The associated increase in PrEP counseling is promising but necessitates further evaluation of the effects of the W-PrEP intervention on the PrEP cascade (eg, initiation, persistence, adherence) in a larger randomized trial.