Cabotegravir PrEP: Actionable Robust Evidence for Translation into Practice (CABARET)

项目总结 尽管高效，口服暴露前预防(PrEP)对HIV发病率的人群影响有限 在美国，部分原因是服药方面的挑战。最近每两个月注射一次卡波替格韦 在男男性行为者(MSM)、变性人中发现比每日口服PrEP更有效 女性，以及顺性女性。长效可注射(LAI)PrEP可以减轻黏附障碍和 持久性，从而增加了PrEP的覆盖面。在一些组织中，对Lai PrEP的兴趣很高，这些组织 艾滋病毒感染风险高得不成比例，在包括Black在内的口服PrEP使用者中代表性不足 妇女、黑人和拉丁裔MSM，这表明Lai PrEP也可以减少种族、民族和性别 PrEP使用中的不平等现象。然而，在服务不足的社区，使用Lai PrEP的障碍可能更常见， 有可能加剧不平等。Lai PrEP由于其较长的半衰期也可能增加耐药风险 或延迟检测艾滋病毒感染。这种风险可以通过口服PrEP减速期或病毒疗法来缓解 在使用过程中进行负载测试，但这些策略的可行性和影响尚不清楚。有力的证据表明 需要及早使用Lai PrEP并取得成果，以设计将艾滋病毒感染降至最低的实施战略， 使用中的不平等，以及抗药性。大规模的口服PrEP研究历来依赖于处方 数据，评估关键决定因素(如种族)、使用障碍或临床结果的能力有限。 医疗保健系统的研究可以将电子健康记录(EHR)数据的广度和深度结合起来 开展定性研究，以指导有效和公平地执行PrEP。我们的研究，Cabotegravir PrEP： 转化为实践的可操作的有力证据(歌舞表演)，将评估现实世界的使用， 对人口的影响，以及最佳的资源投入，以促进实施Lai PrEP。这个 背景是凯撒永久性的3个种族和民族多样化的地区-北加州，大西洋中部 (华盛顿特区、弗吉尼亚州、马里兰州)和佐治亚州-为560万会员和13,000名PrEP用户服务。目标1将提取 并分析EHR数据，以评估LAI PrEP的吸收和持久性，包括 使用，以及艾滋病毒发病率和耐药性。具有提供者和潜在的、当前的和以前的焦点小组 LAI PrEP用户将探索LAI PrEP处方和使用的促进者和障碍，并对以下项目进行过度抽样 黑人女性、黑人和拉丁裔男男性接触者。AIM 2将使用EHR数据参数化的数学建模 评估Lai PrEP对HIV发病率、发病率不平等和耐药性的10年影响。目标 3将使用经济决策模型来确定LAI PrEP采用的成本和效益特征 在有效和公平的艾滋病毒预防战略中，必须优先考虑持续性干预措施。 利益相关者咨询小组将为研究设计、解释和传播提供信息，以最大限度地发挥影响。 这项研究将产生大量的证据来指导《来》的翻译实践，并进行研究 能够在新的PrEP产品出现时集成它们的基础设施。

PROJECT SUMMARY Despite high efficacy, oral preexposure prophylaxis (PrEP) has had limited population impact on HIV incidence in the US, in part because of challenges with pill-taking. Bimonthly injections of cabotegravir were recently found to have superior efficacy to daily oral PrEP among men who have sex with men (MSM), transgender women, and cisgender women. Long-acting injectable (LAI) PrEP could mitigate barriers to adherence and persistence, thereby increasing PrEP coverage. Interest in LAI PrEP has been high in some groups that are at disproportionately high risk of HIV infection and underrepresented among oral PrEP users, including Black women and Black and Latino MSM, suggesting that LAI PrEP could also reduce racial, ethnic, and gender inequities in PrEP use. However, barriers to LAI PrEP use may be more common in underserved communities, potentially exacerbating inequities. LAI PrEP may also increase risk of drug resistance due to its long half-life or delayed detection of HIV infections. This risk may be mitigated by an oral PrEP ramp-down phase or viral load testing during use, but the feasibility and impact of these strategies are unknown. Robust evidence on early use and outcomes of LAI PrEP is needed to design implementation strategies to minimize HIV infections, inequities in use, and drug resistance. Large-scale oral PrEP studies have historically relied on prescription data, with limited ability to evaluate key determinants (e.g., race), barriers to use, or clinical outcomes. Research in healthcare systems can combine the breadth of electronic health record (EHR) data with the depth of qualitative studies to guide efficient and equitable implementation of PrEP. Our study, Cabotegravir PrEP: Actionable Robust Evidence for Translation into Practice (CABARET), will evaluate real-world use, population impact, and optimal investment of resources to facilitate the implementation of LAI PrEP. The settings are 3 racially and ethnically diverse regions of Kaiser Permanente—Northern California, Mid-Atlantic (DC, Virginia, Maryland), and Georgia—serving 5.6 million members and 13,000 PrEP users. Aim 1 will extract and analyze EHR data to evaluate LAI PrEP uptake and persistence, including racial and ethnic inequities in use, and HIV incidence and drug resistance. Focus groups with providers and potential, current, and former LAI PrEP users will explore facilitators and barriers to LAI PrEP prescribing and use, with oversampling of Black women and Black and Latino MSM. Aim 2 will use mathematical modeling parameterized with EHR data to estimate the 10-year impact of LAI PrEP on HIV incidence, inequities in incidence, and drug resistance. Aim 3 will use economic decision modeling to determine the cost and effectiveness features that LAI PrEP uptake and persistence interventions must have to be prioritized in an efficient and equitable HIV-prevention strategy. A stakeholder advisory group will inform study design, interpretation, and dissemination to maximize impact. This study will produce a body of evidence to guide the translation of LAI PrEP into practice, with research infrastructure that can integrate new PrEP products as they emerge.