Controlled Evaluation of the Adherence Readiness Program for ART Adherence

 描述（由申请人提供）：HIV抗逆转录病毒治疗（ART）的成功取决于高水平的依从性，但许多患者发现很难持续良好地依从，导致产生耐药病毒和病毒抑制不完全的风险。 随着最近的治疗指南和新出现的强调治疗即预防推动患者比以往任何时候都更早地开始抗逆转录病毒治疗，与不遵守有关的公共卫生风险现在可能比以前更大。有一些证据表明，早期疾病患者的依从性较低，如果患者在准备好依从性之前开始治疗，则社区耐药池扩大的风险更大，并且传染性降低不足以限制传播。治疗指南强调患者在开始ART之前需要准备好坚持;然而，在开始治疗之前没有确定足够的坚持准备的方法，并且大多数坚持干预措施针对的是一旦接受ART并且有坚持问题的患者。坚持准备计划（阿普），基于行为改变的信息动机行为技能模型，解决了这些需求，包括（1）简短的服药实践试验，以加强治疗前的坚持咨询，并提供一个行为标准，以确定坚持准备和治疗的开始，以及（2）性能驱动的剂量调节机制，以使咨询量（从治疗前到整个治疗过程）适合患者的个人需要并节省有限的资源。在我们的试点RCT中，阿普对行为依从性和病毒学抑制均有影响，其效应量估计值是最近发表的荟萃分析中类似干预措施平均值的两倍以上。有了这些有希望的结果，拟议的5年研究将在一项充分把握度的多中心随机对照试验中评价阿普。240例患者将随机接受阿普或常规治疗。主要结果将是最佳剂量服用（服用85%以上的处方剂量）依从性，如MEMS帽所测量的，以及无法检测到的HIV病毒载量。次要结局将包括给药时间（按时服用85%以上的处方剂量）依从性和CD 4计数。主要终点将是第6个月（短期效果）和第24个月（测试效果的持久性），使其成为少数几项研究干预效果超过一年的研究之一。如果有效，阿普将为临床医生提供干预，（1）通知提供者和患者何时患者准备好坚持并开始治疗，（2）从治疗开始到整个治疗过程中增强依从性准备，以及（3）基于个体患者的需求和表现定制依从性支持的量，从而更有效地使用诊所资源，促进提供者和患者更好地接受，并增加成功采用和传播计划的可能性。对有效利用资源的强调将辅之以成本效益分析，以进一步为有关干预措施的可运输性的政策决定提供信息。

 DESCRIPTION (provided by applicant): The success of HIV antiretroviral therapy (ART) is dependent on high levels of adherence, yet many patients find it difficult to consistently adhere well, resulting in a risk for development of drug resistant virus and incomplete viral suppression. With recent treatment guidelines and the emerging emphasis on Treatment as Prevention pushing for patients to start ART earlier than ever, the public health risks related to nonadherence may now be even greater than before. There is some evidence that patients with earlier stage disease are less adherent, and if patients are started on treatment before they are ready to adhere well there is greater risk for an expanding community pool of resistance, and less than adequate reduction in infectiousness to limit transmission. Treatment guidelines emphasize the need for patients to be ready to adhere well before starting ART; however, there are no established methods for determining sufficient adherence readiness prior to starting treatment, and most adherence interventions target patients once they are on ART and are having adherence problems. The Adherence Readiness Program (ARP), based on the Information Motivation Behavioral skills model of behavior change, addresses these needs and includes (1) brief pill taking practice trials for enhancing pre-treatment adherence counseling and providing a behavioral criterion for determining adherence readiness and the start of treatment, and (2) a performance driven dose regulation mechanism to tailor the amount of counseling (from pre-treatment through the full course of treatment) to the individual needs of the patients and conserve limited resources. In our pilot RCT, the ARP had effects on both behavioral adherence and virologic suppression, with effect sizes estimates that were more than double the average found for similar interventions in a recent published meta-analysis. With these promising results, the proposed 5-year study will evaluate the ARP in a fully powered multi-site randomized controlled trial. A sample of 240 patients will be randomized to receive the ARP or usual care. Primary outcomes will be optimal dose-taking (85+% prescribed doses taken) adherence, as measured by MEMS caps, and undetectable HIV viral load. Secondary outcomes will include dose-timing (85+% prescribed doses taken on time) adherence and CD4 count. Primary end points will be Month 6 (short-term effect) and Month 24 (to test the durability of effect), making it one of the few studies to examine intervention effects longer than one year. If effective, the ARP will provide clinicians with an intervention that (1) informs providers and patients when the patient is ready to adhere well and start treatment, (2) enhances adherence readiness from the outset of treatment through the full course of therapy, and (3) tailors the amount of adherence support based on individual patient need and performance, thus more efficiently using clinic resources, fostering better acceptance from providers and patients, and increasing the likelihood of successful program adoption and dissemination. This emphasis on efficient use of resources will be complemented by a cost-effectiveness analysis to further inform policy decisions regarding the transportability of the intervention.