Accepted for/Published in: JMIR Formative Research
Date Submitted: Jul 14, 2025
Date Accepted: Oct 20, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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
ABSTRACT
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. Clinical Trial: N/A
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.