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Understanding Patient, Provider, and Systems Stakeholder Attitudes and Preferences to Optimize Implementation of Long-Acting Injectable Antiretrovirals and Maximize Clinical and Public Health Impact

了解患者、提供者和系统利益相关者的态度和偏好，以优化长效注射抗逆转录病毒药物的实施并最大限度地提高临床和公共卫生影响

基本信息

批准号：
10615725
负责人：
Katerina A Christopoulos
金额：
$ 79.01万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-01 至 2025-04-30
项目状态：
未结题

项目摘要

Project Summary/Abstract Long-acting injectable antiretroviral therapy (LAI-ART) represents the next innovation in HIV pharmacotherapy and offers enormous promise to minimize challenges to daily oral ART, increase suboptimal rates of virologic suppression in the United States (U.S.), and maximize the ability to end the HIV epidemic. The regimen recently found non-inferior to oral ART in Phase 3 efficacy trials consists of a an intramuscular injection of two antiretrovirals, cabotegravir and rilpivirine, given at 4-week intervals after patients have achieved virologic suppression on oral therapy. In order to translate the promising efficacy of this novel drug platform into real world effectiveness, implementation science is necessary before, during, and after introduction of the product, particularly in clinics serving vulnerable urban HIV populations, as innovations are often delayed in reaching these groups. Implementation research on LAI-ART can identify barriers and bottlenecks to adoption and use to help ensure equitable utilization. LAI-ART holds appeal for at least two groups of patients: 1) those with a history of adherence challenges for whom the extended dosing interval could mitigate psychosocial and structural barriers to daily oral ART; 2) already adherent patients for whom LAI-ART could improve quality of life. Yet without the benefit of a clinic system to support retention, providers may hesitate to use or even withhold LAI-ART from patients who have struggled with adherence to care because of the possibility of drug resistance and viral rebound if doses are missed. For patients on stable oral regimens, clinic burden increases because of an increase in visit frequency to monthly from every 4-12 months. Clinics need systems that support both kinds of patients, but the key features of these care delivery systems are as of yet unknown. This application proposes to comprehensively address the knowledge gap of how best to implement LAI-ART in a way that meets the needs of patients, providers, and clinics in key urban settings using a mixed-methods, multi-level study structured by the Consolidated Framework for Implementation Research (CFIR). Leveraging the expertise of a multidisciplinary team and working in three HIV clinics in high priority Ending the Epidemic jurisdictions (San Francisco, Chicago, and Atlanta) we propose the following specific aims: 1) Evaluate the LAI- ART implementation cascade in three urban HIV clinics; 2) Identify preferred attributes of LAI-ART care delivery among patients and providers; 3) Develop an evidence informed LAI-ART care delivery model to optimize real-world implementation. The proposed research will result in implementation strategies to guide the equitable use of LAI-ART and contribute to Ending the Epidemic efforts in the U.S.

项目摘要/摘要长效注射抗逆转录病毒疗法(LAI-ART)代表着HIV药物疗法的下一个创新并提供了巨大的希望，最大限度地减少对日常口腔艺术的挑战，增加次优病毒率在美国(美国)抑制艾滋病毒，并最大限度地提高结束艾滋病毒流行的能力。养生法最近发现在3期疗效试验中不逊于口服ART的药物包括一次肌肉注射两次抗逆转录病毒药物，卡波替格韦和利培韦林，在患者病毒学检查完成后，每隔4周给药一次对口服治疗的抑制。为了将这一新型药物平台的良好疗效转化为现实世界有效性，实施科学在产品推出之前、期间和之后是必要的，特别是在为脆弱的城市艾滋病毒人群提供服务的诊所，因为创新往往被推迟到这些团体。LAI-ART的实施研究可以识别采用和使用的障碍和瓶颈以帮助确保公平使用。LAI-ART至少对两类患者有吸引力：1)那些有服药间隔延长可缓解心理和社会问题的患者的依从性挑战史日常口腔艺术的结构性障碍；2)已经有依从性的患者，赖亚特可以提高患者的口腔艺术质量生活。然而，如果没有诊所系统的好处来支持保留，提供者可能会犹豫甚至使用对因可能服用药物而在坚持护理方面遇到困难的患者扣留莱阿特如果错过剂量，抵抗力和病毒反弹。对于服用稳定口服方案的患者，临床负担增加因为访问频率从每4-12个月增加到每月一次。诊所需要这样的系统支持这两种患者，但这些护理提供系统的关键特征尚不清楚。这应用程序建议全面解决如何最好地在使用混合方法满足主要城市环境中患者、提供者和诊所的需求的方式，由实施研究综合框架(CFIR)组织的多层次研究。利用一个多学科小组的专业知识，并在三个艾滋病毒诊所工作，高度优先地结束这一流行病司法管辖区(旧金山、芝加哥和亚特兰大)我们提出以下具体目标：1)评估LAI- 在三个城市艾滋病毒诊所实施ART；2)确定LAI-ART护理的优先属性在患者和提供者之间提供服务；3)开发循证知情的Lai-art护理提供模式，以优化现实世界的实施。拟议的研究将产生执行战略，以指导公平使用LAI-ART，并为结束美国的疫情努力做出贡献。