Nelson Katherine L, Evans Cooper Tammeka, Lawson Yolanda, Baker Dylan, Mocherla Satish, Dieterich Megan, Hodge Theo, Dyson Alftan, Sutherland-Philips Denise, Swygard Heidi, Petty Lisa, Jeffery Peter, Sutton Kenneth, Bonner Courtney Peasant, Andrews Sara M, Chang Samantha, Budnik Piotr, Smith Kimberly, de Ruiter Annemiek, Czarnogorski Maggie, Pilgrim Nanlesta
ViiV Healthcare, Durham, North Carolina, USA.
MadeWell OBGYN, Dallas, Texas, USA.
J Int AIDS Soc. 2025 Jul;28 Suppl 2(Suppl 2):e26497. doi: 10.1002/jia2.26497.
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. RESULTS: Ninety-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. GOV NUMBER: NCT05514509.
引言:长效卡博特韦(CAB LA)是首个被批准用于HIV暴露前预防的长效药物。EBONI(NCT05514509)是一项4期实施研究,评估在美国的诊所(包括传染病诊所、初级保健诊所和妇女健康诊所)向黑人顺性别和跨性别女性提供CAB LA的实施情况。我们介绍了医疗保健专业人员(HCP)在最初实施CAB LA阶段的中期观点、考虑因素和策略。 方法:从2022年8月至2024年6月,通过定量调查(实施前[基线]和第4个月[M4])和/或结构化定性访谈(M4),HCP提供了他们在为黑人顺性别和跨性别女性服务的临床环境中整合CAB LA的看法和经验。还每月进行实施监测(IM)电话会议。调查数据使用描述性统计进行分析。定性和IM数据使用基于实施研究综合框架的框架分析方法进行编码和分析。 结果:20个地点的92名HCP完成了基线和M4调查;57%为顺性别女性,43%为黑人。各类诊所的HCP开发了创新方法来支持CAB LA的实施,很少有HCP(<10%)报告对实践准备存在担忧。HCP最初在患者依从性、保险核实和患者识别方面的考虑到M4时有所减少(绝对百分比降低:分别为5 - 14%、5 - 9%和4 - 12%)。为黑人女性服务的各类诊所的HCP报告了成功的实施策略,包括解决医疗不信任和患者教育不足问题、员工培训以及提醒或跟踪系统。各类诊所特有的有用实施策略包括使用电子病历记录是否向患者提供了CAB LA(初级保健诊所)、指定特定日期进行注射(妇女健康诊所)以及为与患者讨论留出时间(传染病诊所)。 结论:一系列常规为黑人顺性别和跨性别女性服务的诊所采用了多种策略来支持CAB LA的实施。通过解决特定人群的担忧、加强员工/患者对CAB LA的教育以及调整临床流程,可以促进CAB LA在临床环境中的实施。EBONI研究中吸取的经验教训有助于支持未来为黑人顺性别和跨性别女性提供的整合服务,并为各种临床环境提供有价值的见解。 政府编号:NCT05514509。
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