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)
基本信息
- 批准号:10708937
- 负责人:
- 金额:$ 81.35万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AIDS preventionAdherenceAffectBenchmarkingBudgetsCaliforniaClinicalContinuity of Patient CareDataDecision ModelingDetectionDevelopmentDrug resistanceEconomic ModelsEconomicsEffectivenessElectronic Health RecordEpidemicEpidemiologyEquityEthnic OriginFocus GroupsFundingGenderGoalsHIVHIV InfectionsHalf-LifeHealthcare SystemsImplantIncidenceInequityInfrastructureInjectableInjectionsInterventionInvestmentsLaboratoriesLatinoMarylandMethodsModalityModelingOralOutcomeParticipantPersonsPhasePoliciesPopulationPrevention strategyProviderQualitative MethodsRaceRampResearchResearch DesignResearch InfrastructureResource AllocationResourcesRiskSamplingTestingTranslationsTreatment FailureUnderserved PopulationUnited States National Institutes of HealthViral Load resultVirginiaVisitWorkblack men who have sex with menblack womencis-femaleclinical practicecostcost effectivenessethnic disparityethnic diversityhigh riskimplementation designimplementation facilitationimplementation strategyimprovedinnovationinterestmathematical modelmembermen who have sex with menphase III trialpillpre-exposure prophylaxisracial disparityracial diversityresource guidestherapy developmenttransgender womenunderserved communityuptake
项目摘要
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,
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Julia L. Marcus其他文献
P1-S2.41 Sentinel survillance for pharyngeal chlamydia and gonorrhoea among men who have sex with men - San Francisco, 2010
P1-S2.41 男男性行为者中咽部衣原体和淋病的哨点监测 - 旧金山,2010 年
- DOI:
- 发表时间:
2011 - 期刊:
- 影响因子:3.6
- 作者:
Jason S. Park;Julia L. Marcus;Kyle T. Bernstein;M. Pandori;Ameera Snell;Susan S. Philip - 通讯作者:
Susan S. Philip
Fracture Risk and Association With TDF Use Among People With HIV in Large Integrated Health Systems
大型综合卫生系统中 HIV 感染者的骨折风险及其与 TDF 使用的关联
- DOI:
- 发表时间:
2023 - 期刊:
- 影响因子:0
- 作者:
R. Hechter;Hui Zhou;W. Leyden;Qing Yuan;Katherine J. Pak;Jennifer O. Lam;Stacey E Alexeeff;Alexandra N. Lea;Haihong Hu;Julia L. Marcus;Adovich S Rivera;Annette L. Adams;M. Horberg;W. Towner;Joan C Lo;Michael J. Silverberg - 通讯作者:
Michael J. Silverberg
Life and Disability Insurance for People with or at Risk of HIV: Aligning Policy with Evidence.
为艾滋病毒携带者或有感染风险的人提供人寿和伤残保险:使政策与证据相一致。
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:0
- 作者:
Benjamin Grobman;Michael J. Silverberg;Julia L. Marcus - 通讯作者:
Julia L. Marcus
Julia L. Marcus的其他文献
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{{ truncateString('Julia L. Marcus', 18)}}的其他基金
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 - 财政年份:2022
- 资助金额:
$ 81.35万 - 项目类别:
Optimizing Care for HIV/HCV-Coinfected Patients in the New HCV Treatment Era
在新的 HCV 治疗时代优化 HIV/HCV 合并感染患者的护理
- 批准号:
9920080 - 财政年份:2017
- 资助金额:
$ 81.35万 - 项目类别:
Optimizing Care for HIV/HCV-Coinfected Patients in the New HCV Treatment Era
在新的 HCV 治疗时代优化 HIV/HCV 合并感染患者的护理
- 批准号:
9302261 - 财政年份:2017
- 资助金额:
$ 81.35万 - 项目类别:
Optimizing Care for HIV/HCV-Coinfected Patients in the New HCV Treatment Era
在新的 HCV 治疗时代优化 HIV/HCV 合并感染患者的护理
- 批准号:
9393181 - 财政年份:2017
- 资助金额:
$ 81.35万 - 项目类别:
Optimizing Care for HIV/HCV-Coinfected Patients in the New HCV Treatment Era
在新的 HCV 治疗时代优化 HIV/HCV 合并感染患者的护理
- 批准号:
9202186 - 财政年份:2016
- 资助金额:
$ 81.35万 - 项目类别:
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