Wagner Glenn
Rand Corporation, Santa Monica, California 90407, USA.
HIV Clin Trials. 2003 Jul-Aug;4(4):269-81. doi: 10.1310/YVTR-T8EV-3TQ6-QAJC.
This study assessed the utility of a placebo practice trial in determining adherence readiness among drug users.
Participants with histories of drug dependency completed a 2-week practice trial that mimicked HAART (Phase 1), followed by a 2-week observation of adherence to HAART (Phase 2) for those who began antiretroviral therapy during the study period. The primary measure of adherence was electronic monitoring.
There were 201 participants enrolled; 39% met criteria for current drug dependency. Mean adherence to the practice trial was 67%. Of the 184 Phase 1 completers, 83 (45%) initiated HAART prior to the end of the study. Mean adherence to HAART was 74%, including 33 patients (39%) with 90+% adherence. Adherence to the practice trial was correlated with antiretroviral adherence (r =.49, p <.001), and 90+% adherence to the practice trial was an accurate marker of the "adherence readiness" (ability to adhere 90+% on HAART) of 72% of the participants. In multivariate analyses, practice trial adherence was the best independent predictor of antiretroviral adherence, accounting for 19% of the explained variance; other predictors included adherence to recent clinic appointments, cognitive functioning, unstable housing, and adherence self-efficacy.
These findings suggest that a brief placebo practice trial has the potential to provide clinicians and patients with an accurate screening tool for evaluating adherence readiness.
本研究评估了安慰剂实践试验在确定吸毒者服药依从性准备情况方面的效用。
有药物依赖史的参与者完成了一项为期2周的模仿高效抗逆转录病毒治疗(HAART)的实践试验(第1阶段),对于在研究期间开始抗逆转录病毒治疗的参与者,随后进行了为期2周的HAART依从性观察(第2阶段)。依从性的主要测量方法是电子监测。
共招募了201名参与者;39%符合当前药物依赖标准。实践试验的平均依从率为67%。在184名完成第1阶段的参与者中,83名(45%)在研究结束前开始了HAART治疗。HAART的平均依从率为74%,其中33名患者(39%)的依从率达到90%以上。实践试验的依从性与抗逆转录病毒治疗的依从性相关(r = 0.49,p < 0.001),实践试验依从率达到90%以上是72%的参与者“具备依从性准备”(在HAART治疗中依从率达到90%以上的能力)的准确标志。在多变量分析中,实践试验依从性是抗逆转录病毒治疗依从性的最佳独立预测因素,占解释方差的19%;其他预测因素包括对近期门诊预约的依从性、认知功能、不稳定住房和依从性自我效能感。
这些发现表明,简短的安慰剂实践试验有可能为临床医生和患者提供一种准确的筛查工具,用于评估依从性准备情况。