Enhancing uptake of PrEP for her via organizational research and individual actions (EUPHORIA): Protocol for a stepped-wedge cluster randomized trial

BACKGROUND: Black/African American cisgender women (hereafter referred to as "Black women") experience one of the highest incidences of HIV yet are often not prioritized in HIV prevention initiatives. For example, pre-exposure prophylaxis (PrEP) for HIV prevention continues to be under-prescribed to women despite its proven effectiveness and demonstrated impact on mitigating HIV transmission. Increasing PrEP initiation and persistence among women through tailored implementation strategies remains crucial to HIV prevention efforts, yet few studies have been designed for women, particularly within the context of family planning centers. This article outlines the study protocol to evaluate the effectiveness of implementation strategies ("EUPHORIA") to improve PrEP care continuum outcomes and to address barriers to PrEP uptake among women in family planning centers in Cook County, Illinois. METHODS: This study builds upon previous work to adapt implementation strategies for increasing PrEP uptake among Black women. The intervention will consist of implementing a combination of strategies and measuring the impact on PrEP utilization among Black women at 8 family planning centers via a stepped-wedge cluster randomized trial. A mixed-methods approach will be utilized to evaluate implementation outcomes and assess the feasibility, acceptability, and effectiveness of the strategies. DISCUSSION: As a result of the intervention, we anticipate that Black women within selected health centers will be more likely to receive PrEP prescriptions. During post-implementation analysis, we will identify key barriers and facilitators within the PrEP care continuum during the implementation process at the patient, provider, and system levels. This study contributes to addressing the inequity in PrEP delivery, aiming to increase initiation and persistence of PrEP for women in family planning centers. If determined effective, these implementation strategies will be further disseminated for use in similar family planning health centers and for future study in potential scale-up.