The Women’s PrEP Project (W-PrEP), a clinic-level, socio-structural intervention to improve provision of pre-exposure prophylaxis (PrEP) for cisgender women: An interrupted time series pilot (Preprint)

BACKGROUND Cisgender women account for 23% of new HIV diagnoses in the United States (US), but there are significant socio-structural barriers to engagement and retention in the PrEP cascade, particularly for women of color. 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-level, socio-structural intervention to measure the preliminary outomes and the feasibility and acceptability of the the adapted intervention, in preparation for a future trial on engagement and retention in the PrEP cascade among women. OBJECTIVE To evaluate the adoption, reach, preliminary effectiveness, and implementation of the W-PrEP intervention, as well as the study instrumentation. METHODS We previously applied the Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, Testing (ADAPT-ITT) 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 Training and Testing: namely to hire and train a PrEP navigator and to train clinic staff to deliver the adapted intervention. We completed a four-month pilot to assess the acceptability and feasibility of the intervention to the clinic-team and patients, the feasibility of collecting the outcome measures, and initial outcome trends (compared to baseline). RESULTS The intervention training was attended by 100% of the clinic team, with significant improvement in knowledge of HIV prevention and PrEP; combined knowledge test scores improved from a mean of 65% to 89% between the pre- and post-test. The clinic team participants found the adapted W-PrEP intervention both highly feasible and acceptable, with minimal impact on clinic flow. Patient participants reported that the W-PrEP intervention was highly acceptable and appreciated the education and counseling from the PrEP navigator—many learning about PrEP for the first time from the navigator and/or health care provider. The outcome measures were both feasible to collect and appropriate to capture the primary outcomes of interest. Lastly, the W-PrEP intervention increased the proportion of patients counseled about PrEP from 65% to 76% of patients seen (p<0.001). CONCLUSIONS The intervention was both acceptable and feasible to the clinic team and intended patient population. The associated increase in PrEP counseling is promising, but necessitates further evaluation of the effects of the W-PrEP intervention on the PrEP cascade (e.g., initiation, persistence, adherence) in a larger randomized trial. CLINICALTRIAL N/A