A TRAINING INTERVENTION TO ENHANCE ADHERENCE TO HAART

加强 HAART 依从性的培训干预

• 批准号: 6392802
• 负责人: DAVID E KANOUSE
• 金额: $ 89.38万
• 依托单位: RAND CORPORATION
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6392802
• 关键词: AIDS therapy; Retroviridae; antiAIDS agent; antiviral agents; behavior modification; behavioral /social science research tag; belief; clinical research; counseling; culture; drug resistance; health behavior; health education; human subject; interview; longitudinal human study; neuropsychology; outcomes research; patient care management; patient monitoring device; questionnaires; social psychology; therapy compliance; virus load

Adherence to highly active antiretroviral therapy (HAART) is vital to successful treatment, including prevention of drug resistance and loss of therapeutic options. Several studies are currently evaluating programs that use a psycho-educational approach to enhance adherence. The proposed study will be the first to examine whether such an intervention is more effective when combined with a practice trial of an inert medication regimen that mimics HAART. The intervention will "hit hard and early" by intervening with patients before they begin treatment to help them get the best start possible and to minimize development of patterns of non-adherence that may be difficult to alter. A sample of 270 patients from 5 university-affiliated HIV outpatient clinics in California who are either initiating or restarting (after a hiatus of at least 6 months) HAART will be randomized into one of 3 conditions: (1) an adherence training intervention with psycho-educational components alone; (2) the same psycho-educational intervention delivered in the context of a brief training trial of an inert medication that mimics HAART; or (3) usual care. The primary outcome will be adherence, which will be assessed using electronic monitoring and self-report at baseline and 1, 3, 6 and 12 months after patients begin HAART. Viral load will be measured at the same time points, together with resistance assays, to assess clinical outcomes at one year. The additive effect of implementing the practice trial will be assessed by comparing adherence at I month following initiation of HAART in the two intervention arms, and both intervention arms will be compared with the usual care control. Adherence subsequent to I month, viral load, and drug resistance will be important secondary outcomes. Longitudinal analyses will be conducted to characterize the lagged effects of adherence on clinical outcomes. Study data will be used to calibrate a structural model of this relationship that could then be used to predict viral load and CD4 trajectory for patients before treatment onset under various adherence assumptions. If proven effective, the training intervention could assist practitioners in preparing their patients to adhere well and gain optimal benefit from HAART.

坚持高效抗逆转录病毒疗法(HAART)至关重要 成功的治疗，包括预防耐药性和丧失 治疗选择。目前有几项研究正在评估使用 一种心理教育方法，以提高忠诚度。拟议的研究将是 第一个研究这种干预是否更有效的方法是 与一种惰性药物方案的实践试验相结合 哈尔特。干预将通过对患者的干预来“重拳出击” 在他们开始治疗之前，帮助他们获得尽可能好的开始，并 最大限度地减少可能难以做到的不遵守模式的发展 改变。5所大学附属HIV门诊270例患者的抽样调查 加州的诊所正在启动或重新启动(在中断后 至少6个月)HAART将随机分为以下3种情况之一：(1) 依从性训练干预单独使用心理教育成分；(2) 同样的心理教育干预是在一个简短的 模拟HAART的惰性药物的培训试验；或(3)常规护理。这个 主要结果将是遵守，这将使用电子评估 患者基线及术后1、3、6、12个月的监测和自我报告 开始HAART。将在相同的时间点测量病毒载量，并与 耐药试验，以评估一年的临床结果。相加效应 实施实践试验的情况将通过比较遵守情况进行评估 在两个干预部门启动HAART后的一个月， 干预组将与常规护理对照组进行比较。坚守 在第一个月之后，病毒载量和耐药性将是重要的 次要结果。将进行纵向分析，以确定 依从性对临床结果的滞后影响。研究数据将用于 校准此关系的结构模型，然后可以使用该模型 在治疗开始前预测患者的病毒载量和CD4轨迹 各种遵守假设。如果被证明有效，培训干预 可以帮助医生为他们的患者做好准备，使他们的患者能够很好地坚持并获得 从HAART中获得最佳收益。