Division of General Internal Medicine, Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY 10467, USA.
Contemp Clin Trials. 2009 Sep;30(5):481-9. doi: 10.1016/j.cct.2009.05.003. Epub 2009 Jun 6.
Directly observed therapy (DOT) programs for HIV treatment have demonstrated feasibility, acceptability, and improved viral suppression, but few have been rigorously tested. We describe a randomized controlled trial testing the efficacy of an antiretroviral DOT program in methadone maintenance clinics. Our objective was to determine if DOT is more efficacious than self-administered antiretroviral therapy for reducing HIV viral load, improving adherence, and reducing drug resistance among opioid dependent drug users receiving methadone treatment.
Participants were randomized to treatment as usual (TAU) or antiretroviral DOT for the 24-week intervention. TAU participants received standard adherence counseling, and DOT participants received standard adherence counseling plus directly observed antiretroviral therapy, which was delivered at the same time as they received daily methadone. Assessments occurred at baseline, weekly for 8 weeks, and then monthly for 4 months. Our primary outcomes were between-group changes from baseline to the end of the intervention in: HIV viral load, antiretroviral adherence, and number of viral mutations.
Between June 2004 and August 2007, we screened 3231 methadone-maintained patients and enrolled 77; 39 participants were randomized to DOT and 38 to TAU. 65 completed the 24-week intervention.
Our trial will allow rigorous evaluation of the efficacy of directly observed antiretroviral therapy delivered in methadone clinics for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among HIV-infected drug users receiving methadone for opioid dependence.
直接观察治疗（DOT）方案在治疗 HIV 方面已经证明了其可行性、可接受性和提高病毒抑制率的效果，但很少有研究对其进行严格的测试。我们描述了一项在美沙酮维持治疗诊所中测试抗逆转录病毒 DOT 方案疗效的随机对照试验。我们的目的是确定 DOT 是否比自我管理的抗逆转录病毒疗法更有效，从而降低 HIV 病毒载量、提高依从性并减少接受美沙酮治疗的阿片类药物依赖者中的耐药性。
参与者被随机分配到治疗组（TAU）或抗逆转录病毒 DOT 组，接受 24 周的干预。TAU 组参与者接受标准的依从性咨询，DOT 组参与者接受标准的依从性咨询和直接观察抗逆转录病毒治疗，与他们接受每日美沙酮治疗同时进行。评估在基线时、第 8 周时每周进行一次、第 4 个月时每月进行一次。我们的主要结局是从基线到干预结束时，两组之间在以下方面的变化：HIV 病毒载量、抗逆转录病毒的依从性和病毒突变数量。
在 2004 年 6 月至 2007 年 8 月期间，我们对 3231 名美沙酮维持治疗的患者进行了筛查，共纳入了 77 名患者；39 名参与者被随机分配到 DOT 组，38 名参与者被分配到 TAU 组。65 名参与者完成了 24 周的干预。
我们的试验将能够严格评估在美沙酮诊所中提供的直接观察抗逆转录病毒治疗方案在提高依从性和临床结局方面的效果。本试验方法的详细描述可以作为未来 DOT 方案开发的模板，并为接受美沙酮治疗阿片类药物依赖的 HIV 感染者的研究提供方案指南。
