ART Adherence: Observed Therapy and Enhanced Counseling

描述（由申请人提供）：抗逆转录病毒治疗（ART）的益处是明确的，然而其有效性取决于严格的依从性，这是困难的，而且通常不是由患者完成的。直接观察治疗（DOT）策略在提高结核病患者治疗依从性方面的成功，促使人们呼吁开展研究，探索其对抗逆转录病毒治疗的潜在疗效。然而，由于需要终身持续用药，目前缺乏真正的每天一次、可观察所有剂量的方案，以及费用高昂，抗逆转录病毒治疗的DOT工作变得复杂。观察每次剂量的另一种选择，称为观察疗法（OT），已作为一种潜在的解决方案提供，并已证明有效。目前，人们正在努力开发额外的每日一次的抗逆转录病毒治疗药物，目的是建立真正的每日一次的治疗方案。随着这些制度的出现，了解OT在不同群落样本中的相对优点和可行性将变得越来越重要。提高治疗依从性的心理教育干预，特别是那些增加动机的干预，已被证明在许多情况下是有效的，包括坚持抗逆转录病毒治疗。在已经开发的干预措施中，增加改变的动机是一种被称为动机性访谈（MI）的咨询方法。一些对照治疗结果的研究已经证明了MI咨询方法对包括坚持抗逆转录病毒治疗在内的几种健康行为的有效性。由于其中立和支持的立场，MI可能在培养增强坚持抗逆转录病毒治疗的动机方面特别有效。我们建议对开始新的抗逆转录病毒治疗方案的患者进行为期5年的随机对照试验，分配给观察治疗的强化咨询、单独强化咨询或标准治疗，在基线、3、6和12个月进行评估，并在1年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治疗更有效地提高抗逆转录病毒治疗的依从性。2)确定强化咨询联合观察治疗在降低病毒载量方面是否比单独强化咨询或标准治疗更有效；3)评估潜在介质和调节因子对依从性和HIV RNA水平的作用。

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.