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

卡博特韦 PrEP：转化为实践的可行有力证据 (CABARET)

• 批准号: 10618609
• 负责人: Julia L. Marcus
• 金额: $ 89.64万
• 依托单位: HARVARD PILGRIM HEALTH CARE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-21 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618609
• 关键词: AIDS prevention; Adherence; Affect; Benchmarking; Black race; Budgets; California; Clinical; Continuity of Patient Care; Data; Decision Modeling; Detection; Development; Drug resistance; Economic Models; Economics; Electronic Health Record; Epidemic; Epidemiology; Face; Focus Groups; Funding; Gender; Goals; HIV; HIV Infections; Half-Life; Healthcare Systems; Implant; Incidence; Infrastructure; Injectable; Injections; Intervention; Investments; Laboratories; Latino; Maryland; Methods; Modality; Modeling; Oral; Outcome; Participant; Persons; Phase; Policies; Population; Prevention strategy; Prophylactic treatment; Provider; Qualitative Methods; Race; Ramp; Research; Research Design; Research Infrastructure; Resource Allocation; Resources; Risk; Testing; Translations; Treatment Failure; Underserved Population; United States National Institutes of Health; Viral Load result; Virginia; Visit; Work; base; black women; cis-female; clinical practice; cost effectiveness; ethnic diversity; high risk; implementation design; implementation facilitation; implementation strategy; improved; innovation; interest; mathematical model; member; men who have sex with men; phase III trial; pill; racial and ethnic; racial diversity; resource guides; therapy development; transgender women; underserved community; uptake

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.

项目概要 尽管口服暴露前预防 (PrEP) 的功效很高，但它对艾滋病毒发病率的人群影响有限 在美国，部分原因是服药带来的挑战。最近每两个月注射一次卡博特韦 研究发现，对于男男性行为者 (MSM)、变性人来说，每日口服 PrEP 的疗效优于每日口服 PrEP 女性和顺性别女性。长效注射剂 (LAI) PrEP 可以减轻依从性和预防方面的障碍 持久性，从而提高 PrEP 覆盖率。某些群体对 LAI PrEP 的兴趣很高 HIV 感染风险极高且口服 PrEP 使用者（包括黑人）的比例不足 女性以及黑人和拉丁裔男男性行为者，表明 LAI PrEP 还可以减少种族、民族和性别 PrEP 使用中的不平等。然而，在服务欠缺的社区中，使用 LAI PrEP 的障碍可能更为常见， 可能会加剧不平等。由于半衰期长，LAI PrEP 也可能增加耐药性风险 或艾滋病毒感染的延迟检测。这种风险可以通过口服 PrEP 减量阶段或病毒治疗来减轻 使用期间进行负载测试，但这些策略的可行性和影响尚不清楚。强有力的证据 需要尽早使用 LAI PrEP 并取得成果来设计实施策略，以尽量减少 HIV 感染， 使用不公平和耐药性。大规模口服 PrEP 研究历来依赖处方 数据，评估关键决定因素（例如种族）、使用障碍或临床结果的能力有限。 医疗保健系统研究可以将电子健康记录 (EHR) 数据的广度与深度结合起来 定性研究，以指导有效和公平地实施 PrEP。我们的研究 Cabotegravir PrEP： 用于转化为实践的可操作的强有力证据（CABARET）将评估现实世界的使用， 人口影响以及优化资源投资以促进 LAI PrEP 的实施。这 设置是 Kaiser Permanente 的 3 个种族和民族多样化地区——北加州、中大西洋 （华盛顿特区、弗吉尼亚州、马里兰州）和佐治亚州——为 560 万名会员和 13,000 名 PrEP 用户提供服务。目标1将提取 并分析 EHR 数据以评估 LAI PrEP 的吸收和持久性，包括种族和民族不平等 使用、艾滋病毒发病率和耐药性。焦点小组与提供者和潜在的、当前的和以前的提供者 LAI PrEP 用户将探索 LAI PrEP 处方和使用的促进因素和障碍，并对 黑人女性以及黑人和拉丁裔男男性接触者。目标 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。目的 3 将使用经济决策模型来确定 LAI PrEP 采用的成本和有效性特征 有效和公平的艾滋病毒预防战略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。 这项研究将提供大量证据来指导 LAI PrEP 转化为实践，并进行研究 可以在新的 PrEP 产品出现时将其集成的基础设施。