ART Adherence: Observed Therapy and Enhanced Counseling

说明(申请人提供)：抗逆转录病毒疗法(ART)的好处是明确的，但其有效性取决于严格遵守，这是困难的，通常不是由患者完成的。提高结核病治疗依从性的直接观察疗法(DOT)策略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，抗逆转录病毒治疗的DOT由于需要继续终身用药、目前缺乏真正的一天一次、可以观察所有剂量的方案以及高昂的费用而变得复杂。一种观察每一次剂量的替代方案，称为观察疗法(OT)，已被作为一种潜在的解决方案提供，并已证明了一些有效性。目前正在努力开发更多的每日一次的抗逆转录病毒药物，目标是创建真正的一天一次的制度。随着这些机制的出现，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。心理教育干预以提高对治疗的依从性，特别是那些增加动力的干预措施，已被证明在许多情况下是有效的，包括对艺术的坚持。在为增加变革动力而开发的干预措施中，有一种被称为动机访谈(MI)的咨询方法。许多对照治疗结果研究表明，心肌梗塞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是有效的。由于其中立和支持的立场，MI可能在促进增强坚持艺术的动机方面特别有效。我们建议对开始新的ART方案的患者进行为期5年的随机对照试验，分配给加强咨询与观察治疗，单独加强咨询，或在基线、3、6和12个月进行评估的标准护理，并在1年评估病毒载量依从性和次要结果的主要测试。本研究的具体目的如下：1)确定强化咨询结合观察疗法在提高患者对抗逆转录病毒治疗的依从性方面是否比单纯强化咨询或标准护理更有效。2)确定强化咨询结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护理更有效。以及3)评估潜在的调节因子和调节因子在依从性和HIV RNA水平上的作用。

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.