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: 10708937
• 负责人: Julia L. Marcus
• 金额: $ 81.35万
• 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/10708937
• 关键词: AIDS prevention; Adherence; Affect; Benchmarking; Budgets; California; Clinical; Continuity of Patient Care; Data; Decision Modeling; Detection; Development; Drug resistance; Economic Models; Economics; Effectiveness; Electronic Health Record; Epidemic; Epidemiology; Equity; Ethnic Origin; Focus Groups; Funding; Gender; Goals; HIV; HIV Infections; Half-Life; Healthcare Systems; Implant; Incidence; Inequity; Infrastructure; Injectable; Injections; Intervention; Investments; Laboratories; Latino; Maryland; Methods; Modality; Modeling; Oral; Outcome; Participant; Persons; Phase; Policies; Population; Prevention strategy; Provider; Qualitative Methods; Race; Ramp; Research; Research Design; Research Infrastructure; Resource Allocation; Resources; Risk; Sampling; Testing; Translations; Treatment Failure; Underserved Population; United States National Institutes of Health; Viral Load result; Virginia; Visit; Work; black men who have sex with men; black women; cis-female; clinical practice; cost; cost effectiveness; ethnic disparity; 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; pre-exposure prophylaxis; racial disparity; 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 尽管效力很高，但口服预防（PREP）对艾滋病毒的侵害的影响有限 在美国，部分原因是服用药丸的挑战。 发现与男性发生性关系的孟男性（MSM），变性人的每日口头准备具有较高的功效 妇女和cisgender妇女。 持久性，从而增加了对LAI准备的兴趣。 艾滋病毒艾滋病毒感染的高度高风险和口服准备用户的表现不足，包括黑色 妇女以及黑人和拉丁裔MSM，建议赖预科也可以减少种族，种族和性别 但是，准备使用的不平等。 潜在的加剧不平等。 或延迟对艾滋病毒感染的检测。 使用期间的负载测试，但是这些策略的可行性和影响尚不清楚 需要早期使用和结果来设计实施方式以最大程度地减少艾滋病毒感染， 使用的不平等和耐药性。 数据，评估关键决定因素（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，以指导效率和公平的PREP实施。 可行的强大证据以练习（Cabaret），将评估现实世界中的使用， 人口影响和最佳资源投资，以促进LAI PREP的实施 Kaiser Permanente的种族和种族不同地区是3个环境 - 北加州，中大西洋地区 （DC，弗吉尼亚州，马里兰州）和佐治亚州 - 服务560万成员和13,000名AIM 1。 并分析EHR数据以评估LAI的准备吸收和持久性，包括种族和种族不平等 使用，艾滋病毒的抗药性和抗药性组。 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 黑人妇女和黑人和拉丁裔MSM。 估计LAI道具对HIV发病率，发病率和耐药性的10年影响。 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 持久性干预必须在公平且公平的预防策略中优先考虑。 利益相关者咨询小组Willm研究设计，解释和传播，以最大程度地发挥影响力。 通过研究 可以在新产品出现的基础架构中整合它们。