The Bridge Clinic: Optimizing Injectable PrEP Delivery for Transgender and Non-Binary People

项目摘要/摘要 变性人和非二进制(TNB)人感染艾滋病毒的比例不成比例，随着越来越多的人 2015-2019年的新诊断数量。暴露前预防(PrEP)有很大的潜力减少 新的艾滋病毒感染情况有所改善，但尚未改善TNB人群中的艾滋病毒差距。与最近的FDA 批准长效可注射卡波替格韦(CAB-LA)用于PrEP，现在是利用这一点的关键机会 在TNB人群中增加PrEP使用的科学进展。在之前的工作中，我们试行了一种灵活的、低成本的- 门槛，转肯定PrEP临床(桥诊所)，实现更高的PrEP摄取率并达到TNB 与在确认性别的初级保健诊所接受PrEP的人相比，感染艾滋病毒的风险更高。 桥梁诊所模式的关键组成部分包括护士领导的灵活工作时间的PrEP诊所； 由跨同行导航器提供支持；通过CDC认可的PrEPmate提供文本消息支持 循证干预；交通支持；以及TNB社区主导的PrEP意识 竞选活动。在这项提案中，我们将使用快速周期研究(RCR)方法来加强桥梁诊所 为了整合CAB-LA交付，通过迭代调整来改进此模型，并评估关键实施 结果。我们还将评估性别肯定激素和CAB-LA之间的任何药物相互作用，以及 这是TNB社区需要解决的重要问题。在目标1中，我们将进行一系列名义小组 与说英语和西班牙语的TNB人员以及与他们的提供者的半结构化访谈一起探索 患者和提供商确定了TNB社区中CAB-LA交付的障碍和促进者。我们还将 收集有关我们实施策略的反馈，以指导我们增强协议和参与度 整合CAB-LA的方法。在目标2中，我们将实施CAB-LA增强型桥梁诊所模式 在为期3年的200名TNB个体的开放队列中，在RCR的指导下进行中期适应 进程。使用RE-AIM框架，我们将评估覆盖范围、有效性、采用、实施、 通过调查和采访提供商、工作人员和 患者，以及病历数据的审查。在目标3中，我们将招募一部分接受注射的参与者 在Bridge诊所准备进行两项药代动力学亚研究以评估性别的双向影响 确认激素治疗和卡替格雷在TNB患者中的血药浓度。我们的工作跨越AIMS 将由一个利益相关者咨询委员会指导，该委员会由地方和国家社区活动家、领导人、 卫生专业人员和服务于TNB社区的工作人员，他们将每季度开会一次，就研究提供意见 设计和实施，调整优先顺序，并确保桥梁诊所模式具有通用性 到其他练习环境。研究完成后，我们将优化和评估一种新的PrEP交付 在TNB人群中增加对长效注射PrEP的摄取和持久性的模型，并进行药物评估 在真实的TNB人群中，性别肯定激素和CAB-LA之间的相互作用。

Project Summary/Abstract Transgender and nonbinary (TNB) people are disproportionately affected by HIV, with increasing numbers of new diagnoses from 2015-2019. Pre-exposure prophylaxis (PrEP) has great potential to reduce new HIV infections, but has yet to improve HIV disparities among TNB populations. With the recent FDA approval of long-acting injectable cabotegravir (CAB-LA) for PrEP, there is a critical opportunity to leverage this scientific advance to increase PrEP use in TNB populations. In prior work, we piloted a flexible, low- threshold, trans-affirming PrEP clinic (Bridge Clinic) which achieved higher PrEP uptake and reached TNB individuals at higher risk for HIV acquisition than those receiving PrEP in gender affirming primary care clinics. Key components of the Bridge Clinic model include a nurse-led PrEP clinic with flexible hours; PrEP support provided by a trans peer navigator; text-messaging support via PrEPmate, a CDC-endorsed evidence based intervention; transportation support; and a TNB community-led PrEP awareness campaign. In this proposal, we will use Rapid-Cycle Research (RCR) methods to enhance the Bridge Clinic to incorporate CAB-LA delivery, refine this model through iterative adaptations, and assess key implementation outcomes. We will also evaluate for any drug interactions between gender affirming hormones and CAB-LA, an important question to address for the TNB community. In aim 1, we will conduct a series of nominal groups with English- and Spanish-speaking TNB people and semi-structured interviews with their providers to explore patient- and provider-identified barriers and facilitators to CAB-LA delivery in the TNB community. We will also elicit feedback on our implementation strategies to guide the enhancement of our protocol and engagement approaches to incorporate CAB-LA. In aim 2, we will implement the CAB-LA Enhanced Bridge Clinic model in an open cohort of 200 TNB individuals over a 3-year period, with mid-course adaptations guided by the RCR process. Using the RE-AIM framework, we will assess the reach, effectiveness, adoption, implementation, and maintenance of the Enhanced Bridge Clinic model via surveys and interviews with providers, staff, and patients, and medical record data review. In aim 3, we will enroll a subset of participants receiving injectable PrEP at the Bridge Clinic into two pharmacokinetic substudies to evaluate the bidirectional effects of gender affirming hormone therapy and cabotegravir plasma concentrations in TNB individuals. Our work across aims will be guided by a Stakeholder Advisory Board comprised of local and national community activists, leaders, health professionals, and staff serving the TNB community who will meet quarterly to provide input on study design and implementation, prioritization of adaptations, and ensuring the Bridge Clinic model is generalizable to other practice settings. Upon study completion, we will have optimized and evaluated a novel PrEP delivery model to increase uptake and persistence to long-acting injectable PrEP in TNB people, and assessed for drug interactions between gender affirming hormones and CAB-LA in a real-world cohort of TNB individuals.