Accepted for/Published in: JMIR Formative Research
Date Submitted: Apr 13, 2025
Date Accepted: Jun 14, 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Warning: This is an author submission that is not peer-reviewed or edited.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): development of a clinic-based, socio-structural intervention to improve provision of pre-exposure prophylaxis (PrEP) for cisgender women using the ADAPT-ITT framework
ABSTRACT
Background:
Cisgender women (subsequently referred to as 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.
Objective:
In response to the lack of evidence-based interventions to improve PrEP initiation, adherence, and persistence among women in the United States, we set out to develop a clinic-based, socio-structural intervention focused on engagement and retention in the PrEP cascade among women.
Methods:
We utilized the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, Testing) model to create a culturally-appropriate, evidence-based intervention responsive to Black women’s HIV prevention needs. In this manuscript we focus on the first six steps of iterative adaptation in preparation for pilot testing. We conducted semi-structured interviews and focus group discussions with key populations to inform and guide intervention development and employed Theater Testing to evaluate the mock-up of the prototype. We conducted rapid qualitative analysis (RQA) to identify key themes around delivering PrEP to the intended population, and engaged subject matter experts to refine the prototype.
Results:
Assessment: We conducted n=10 in-depth interviews with key informants from community-based and HIV-prevention organizations, and led n=7 focus group discussions (participant n range 4 to 8) to guide intervention development among medical providers (n=2 groups), PrEP navigators and educators (n=1 group), and female patients (n=4 groups). Key themes included population specific barriers to PrEP utilization, namely accessibility/availability, perceived risk, and stigma. Additionally, participants advised on model adaptation specific to PrEP navigation, clinic-level training and social support. Decision: We selected two evidence based-interventions from the Centers for Disease Control Compendium of Best Practices in HIV Prevention. Adaptation: We adapted and theater tested a preliminary intervention for feedback. Production: Using feedback from theater testing, we created a prototype of “the Women’s PrEP Project (W-PrEP)” designed to address patient-, provider-, and clinic-level barriers to provision of PrEP for women though a clinic-wide intervention delivering education, resources, and support (including PrEP navigation). Topical Experts & Integration: We collected iterative feedback from our advisory board and subject matter experts and integrated feedback into the final prototype.
Conclusions:
The adaptation of the W-PrEP program integrated key elements of the local context for cisgender women with potential exposure to HIV, as well as medical providers, clinic-staff, and PrEP navigators. Next steps include training clinic staff in a real-world setting to pilot test the acceptability, feasibility, and preliminary effectiveness of the intervention. Clinical Trial: N/A
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