ART Adherence: Observed Therapy and Enhanced Counseling

描述（由申请人提供）：抗逆转录病毒治疗（ART）的好处是显而易见的，但其有效性取决于严格的依从性，这很困难，而且患者通常不会做到。直接观察治疗（DOT）策略在结核病治疗依从性增加的成功，导致呼吁研究探索其潜在的疗效ART。然而，DOT ART是复杂的需要继续药物治疗的生活，目前缺乏真正的一天一次的制度，所有剂量可以观察到，和高成本。观察每一剂量的替代方案，称为观察治疗（OT），已被作为一种潜在的解决方案提供，并具有一定的疗效。 目前正在努力开发额外的每日一次抗逆转录病毒药物，目标是创造真正的每日一次方案。随着这些制度的出现，了解OT在不同社区样本中的相对优点和可行性将变得越来越重要。心理教育干预，以增加坚持治疗，特别是那些增加动机，已被证明是有效的，在一些情况下，包括坚持艺术。在已开发的干预措施，以增加改变的动机是一个咨询方法被称为动机访谈（MI）。 一些对照治疗结果研究已经证明了MI咨询方法对几种健康行为的有效性，包括坚持ART。由于其中立和支持的立场，MI可能在促进增强坚持ART的动机方面特别有效。我们建议对开始新ART方案的患者进行为期5年的随机对照试验，这些患者被分配到观察治疗的增强咨询，单独加强咨询或标准治疗，在基线、3、6和12个月进行评估，并在1年时评估依从性的主要测试和病毒载量的次要结果。本研究的具体目的如下：1）确定强化咨询结合观察治疗是否比单独强化咨询或标准护理更有效地增加ART的依从性。2）确定强化咨询结合观察治疗是否比单独强化咨询或标准护理更有效地降低病毒载量。（3）评价潜在的调节因子对依从性和HIV RNA水平的影响。

DESCRIPTION (provided by applicant): The benefits of antiretroviral therapy (ART) are clear, however its effectiveness is dependent on strict adherence, which is difficult and not often accomplished by patients. The success of directly observed therapy (DOT) strategies for increasing treatment adherence in tuberculosis has led to calls for research exploring its potential efficacy for ART. However, DOT for ART is complicated by the need to continue medication for life, the current lack of truly once-a-day regimes where all doses can be observed, and the high cost. An alternative to observing every dose, called observed therapy (OT), has been offered as a potential solution and has some demonstrated efficacy. Great effort is currently focused on developing additional once daily ART medications with the goal of creating truly once-a-day regimes. As these regimes become available, it will be increasingly important to understand the relative merits and feasibility of OT in diverse community samples. Psycho educational interventions to increase adherence to therapy, especially those that increase motivation, have been shown to be effective in a number of contexts, including adherences to ART. Among the interventions that have been developed to increase motivation for change is a counseling approach known as Motivational Interviewing (MI). A number of controlled treatment outcomes studies have demonstrated the efficacy of MI counseling approaches for several health behaviors including adherence to ART. Because of its neutral and supportive stance, MI may be particularly effective in fostering enhancing motivation to adhere to ART. We propose a 5 year randomized controlled trial of patients starting a new ART regime assigned to enhanced counseling with observed therapy, enhanced counseling alone, or standard care with assessments conducted at baseline, 3, 6, and 12 months, and the primary test of adherence and secondary outcome of viral load assessed at 1 year. The specific aims of this study are as follows: 1) To determine whether enhanced counseling combined with observed therapy is more effective than enhanced counseling alone or standard care in increasing adherence to ART. 2) To determine whether enhanced counseling combined with observed therapy is more effective than enhanced counseling alone or standard care in decreasing viral load.; and 3) To evaluate the role of potential mediators and moderators on adherence and HIV RNA levels.