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.

项目摘要 尽管效率很高，但口服预防预防（PREP）对艾滋病毒事件的影响有限 在美国，部分原因是服用药丸的挑战。两次注射Cabotegravir最近是 发现与男性发生性关系的男性（MSM），变性人的效率较高 妇女和赋予妇女。长效注射（LAI）准备可以减轻遵循的障碍和 持久性，从而增加了准备覆盖范围。对某些在 艾滋病毒感染的高风险不成比例，口腔准备用户（包括黑人）的占人数不足 妇女以及黑人和拉丁裔MSM，这表明赖准备也可以减少种族，种族和性别 准备使用中的不平等。但是，在服务不足的社区中，LAI Prep使用的障碍可能更常见 潜在加剧不平等。赖（Lai Prep）也可能增加由于其长期寿命而增加耐药性的风险 或延迟对HIV感染的检测。口头准备坡道阶段或病毒可能会降低这种风险 使用过程中的负载测试，但是这些策略的可行性和影响尚不清楚。有力的证据 需要早期使用和结果来设计实施策略以最大程度地减少艾滋病毒感染， 使用中的摄入量和耐药性。大规模的口腔预备研究历史上已经放松了处方 数据，评估关键决定者（例如种族），使用障碍或临床结果的数据有限。 医疗保健系统的研究可以将电子健康记录（EHR）数据的广度与深度相结合 定性研究以指导PREP的有效和公平实施。我们的研究，Cabotegravir Prep： 可行的强大证据以练习（Cabaret），将评估现实世界中的使用， 人口影响，以及对促进LAI PREP实施的资源的最佳投资。这 Kaiser Permanente的范围和种族不同的地区是3个地区，加利福尼亚州北部北部地区 （DC，弗吉尼亚州，马里兰州）和佐治亚州 - 拥有560万成员和13,000名预备使用者。 AIM 1将提取 并分析EHR数据以评估LAI的准备吸收和持久性，包括赛车和种族询问 使用，艾滋病毒的发病率和耐药性。焦点小组与提供者以及潜力，当前和以前的焦点小组 LAI Prep用户将探索促进者和LAI准备处方和使用的障碍，并过采样 黑人妇女以及黑人和拉丁裔MSM。 AIM 2将使用使用EHR数据参数化的数学建模 估计LAI PREP对HIV事件，事件不平等和耐药性的10年影响。目的 3将使用经济决策建模来确定LAI准备吸收的成本和有效性功能 持久性干预措施必须在有效且公平的预防策略中优先考虑。 利益相关者咨询小组将为研究，解释和传播提供信息，以最大程度地发挥影响力。 这项研究将产生大量证据，以指导LAI PREP转化为实践，并进行研究 可以在出现新的预备产品的基础架构。