A TRAINING INTERVENTION TO ENHANCE ADHERENCE TO HAART

加强 HAART 依从性的培训干预

• 批准号: 6528840
• 负责人: DAVID E KANOUSE
• 金额: $ 85.31万
• 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/6528840
• 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治疗（HAART）至关重要 成功治疗，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 心理教育方法，以提高坚持。拟议的研究将 第一个研究这种干预是否更有效的是， 结合一个模拟惰性药物疗法的实践试验， HAART。通过对患者进行干预，干预将“重拳出击、早打” 在他们开始治疗之前，帮助他们获得最好的开始， 最大限度地减少不遵守模式的发展， 改变。对5所高校艾滋病门诊270例患者的调查分析 加州的诊所，他们正在启动或重新启动（中断后 至少6个月）HAART将随机分为3种情况之一：（1） 坚持训练干预与心理教育成分单独;（2） 同样的心理教育干预， 模拟HAART的惰性药物的培训试验;或（3）常规护理。的 主要结局是依从性，将使用电子 在基线和患者术后1、3、6和12个月进行监测和自我报告 开始HAART。将在相同时间点测量病毒载量， 耐药性测定，以评估一年的临床结果。加性效应 实施实践试验的效果将通过比较I 两个干预组开始HAART治疗后1个月， 将干预组与常规护理对照组进行比较。粘附 1个月后，病毒载量和耐药性将变得重要 次要结果。将进行纵向分析， 依从性对临床结局的滞后效应。研究数据将用于 校准这种关系的结构模型，然后可以用来 在治疗开始前预测患者的病毒载量和CD 4轨迹， 不同的假设。如果证明有效，培训干预 可以帮助医生准备他们的病人坚持良好， 从HAART中获得最佳效益。