Strategies for implementing long-acting cabotegravir for PrEP in US clinics serving black women

Abstract

Introduction Long-acting cabotegravir (CAB LA) is the first LA agent approved for HIV pre-exposure prophylaxis. EBONI (NCT05514509) is a Phase 4 implementation study evaluating the implementation of CAB LA delivery to Black cis- and transgender (cis-and-trans) women in clinics located in the United States, including infectious disease (ID), primary care (PC) and women's health (WH) clinics. We present interim perspectives, considerations and strategies from healthcare professionals' (HCPs') experiences during the initial implementation stages of administering CAB LA. Methods From August 2022 to June 2024, through quantitative surveys (prior to implementation [baseline] and Month 4 [M4]) and/or structured qualitative interviews (M4), HCPs provided their perceptions and experiences of integrating CAB LA in their clinical settings that served Black cis-and-trans women. Monthly implementation monitoring (IM) calls were also conducted. Survey data were analysed using descriptive statistics. Qualitative and IM data were coded and analysed using a Framework Analysis approach grounded in the Consolidated Framework for Implementation Research.ResultsNinety-two HCPs across 20 sites completed baseline and M4 surveys; 57% were cisgender female and 43% were Black. HCPs across clinic types developed innovative approaches to support CAB LA implementation, with few HCPs (< 10%) reporting concerns about practice preparation. Initial HCP considerations related to patient adherence, insurance verification and patient identification reduced by M4 (absolute % reduction: 5-14%; 5-9%; and 4-12%, respectively). HCPs across clinic types serving Black women reported successful implementation strategies, including addressing medical mistrust and patient miseducation, staff training and reminder or tracking systems. Useful implementation strategies unique to clinic types included using electronic medical records to document whether patients were offered CAB LA (PC), designating specific days for administering injections (WH) and creating time for discussion with patients (ID). Conclusions A range of strategies across clinics that routinely serve Black cis-and-trans women were used to support CAB LA implementation. Implementing CAB LA in clinical settings can be bolstered by addressing population-specific concerns, increasing staff/patient education about CAB LA and modifying clinical flows. Lessons learned in EBONI can help support future integration for Black cis- and transgender women and provide valuable insights for various clinical environments.ClinicalTrials.gov numberNCT05514509