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

项目总结/摘要 长效注射抗逆转录病毒疗法（LAI-ART）代表了艾滋病毒药物治疗的下一个创新 并提供了巨大的希望，以尽量减少对日常口服ART的挑战，增加病毒学的次优率， 在美国的镇压（美国），最大限度地消除艾滋病的蔓延。所述方案 最近在3期疗效试验中发现的非劣效于口服ART的药物包括肌内注射两种 抗逆转录病毒药物，卡替拉韦和利匹韦林，在患者达到病毒学 抑制口服治疗。为了将这一新型药物平台的良好疗效转化为真实的 世界的有效性，实施科学是必要的之前，期间，和之后的产品介绍， 特别是在为城市艾滋病毒脆弱人群提供服务的诊所，因为创新往往被推迟， 这些团体。LAI-ART的实施研究可以确定采用和使用的障碍和瓶颈 以确保公平使用。LAI-ART至少对两类患者有吸引力：1）患有 有依从性挑战史，延长给药间隔可缓解其心理社会和 每日口服ART的结构性障碍; 2）LAI-ART可以改善其质量的已经依从的患者， 生活然而，如果没有诊所系统的好处，以支持保留，供应商可能会犹豫使用，甚至 由于药物的可能性，对难以坚持护理的患者停止LAI-ART 如果漏服剂量，则会出现耐药性和病毒反弹。对于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。诊所需要的系统， 支持这两种类型的患者，但这些护理提供系统的关键特征是未知的。这 申请建议全面解决如何最好地实施LAI-ART的知识差距， 在主要城市环境中使用混合方法满足患者、提供者和诊所需求的方式， 实施研究综合框架（CFIR）构建的多层次研究。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， 司法管辖区（旧金山弗朗西斯科，芝加哥和亚特兰大），我们提出了以下具体目标：1）评估LAI- 在三个城市艾滋病毒诊所实施抗逆转录病毒疗法; 2）确定LAI-ART护理的首选属性 患者和提供者之间的交付; 3）制定一个有证据的LAI-ART护理交付模式， 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，并为结束美国的流行病努力做出贡献。

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.