Controlled Evaluation of the Adherence Readiness Program for ART Adherence

 描述(申请人提供)：艾滋病毒抗逆转录病毒疗法(ART)的成功依赖于高水平的依从性，但许多患者发现很难持续良好地依从性，导致出现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对治疗作为预防的重视的出现，推动患者比以往任何时候都更早开始抗逆转录病毒治疗，与不坚持治疗相关的公共健康风险现在可能比以前更大。有一些证据表明，早期疾病的患者粘附性较差，如果患者在准备好很好地粘附性之前就开始治疗，那么社区抵抗力池扩大的风险更大，传染性的降低也不足以限制传播。治疗指南强调患者在开始抗逆转录病毒治疗之前需要做好充分的坚持准备；然而，在开始治疗之前没有确定足够的坚持准备的既定方法，大多数坚持干预措施针对的是接受抗逆转录病毒治疗并出现坚持问题的患者。依从性准备计划(ARP)以行为改变的信息动机行为技能模型为基础，解决了这些需求，并包括(1)简短的药丸服用实践试验，以加强治疗前的依从性咨询，并为确定依从性准备和治疗开始提供行为标准，(2)绩效驱动的剂量调节机制，以根据患者的个人需求定制咨询量(从治疗前到整个治疗过程)，并节省有限的资源。在我们的试验性随机对照试验中，ARP对行为依从性和病毒学抑制都有影响，其影响大小估计是最近发表的一项荟萃分析中类似干预措施的平均水平的两倍多。有了这些有希望的结果，拟议的为期5年的研究将在一项完全有效的多地点随机对照试验中评估ARP。240名患者的样本将随机接受ARP或常规护理。主要结果将是最佳剂量服用(85+%处方剂量服用)依从性，以MEMS上限衡量，以及无法检测到的艾滋病毒病毒载量。次要结果将包括剂量时机(85%以上的处方剂量按时服用)、依从性和CD4计数。主要终点将是6个月(短期效果)和24个月(以测试效果的持久性)，使其成为少数几项检查干预效果超过一年的研究之一。如果有效，ARP将为临床医生提供以下干预措施：(1)当患者准备好坚持并开始治疗时，通知提供者和患者，(2)从治疗开始到整个治疗过程都增强坚持准备，以及(3)根据患者个人需求和表现定制坚持支持的数量，从而更有效地利用临床资源，促进提供者和患者更好地接受，并增加计划成功采用和传播的可能性。这种对有效利用资源的强调将得到成本效益分析的补充，以进一步为有关干预措施可转移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.