Efficacy and cost of HAART DOT in methadone clinics

描述（由申请人提供）：吸毒者占艾滋病病例的很大比例；然而，他们从高效抗逆转录病毒治疗（HAART）中获得的益处却比非吸毒者少得多。最近的报告表明，HAART在吸毒者中未得到充分利用，有注射吸毒史的人可能比非吸毒者更不可能达到维持病毒抑制所需的坚持程度。为了改善艾滋病毒感染吸毒者获得抗逆转录病毒药物治疗的机会和依从性，正在迅速发展与艾滋病毒有关和药物滥用综合治疗的新模式。提供这种治疗的一种创新模式是，在美沙酮维持计划中提供艾滋病毒现场初级保健，已在几项研究中证明可以改善健康结果。直接观察疗法（DOT）在美沙酮项目和其他环境中有效治疗结核病，是该模式的合理延伸，有可能显著提高HAART的依从性。然而，仅报道了DOT对艾滋病毒有效性的初步研究结果，而且这些数据并不一致。虽然在一些非对照研究中，80-100%的HIV DOT患者达到了无法检测到的病毒载量，但其他DOT试点研究发现，达到这一结果的比例为60-65%。此外，通过促进依从性的适度改善，艾滋病毒的DOT可能矛盾地增加耐药性的风险。要判断DOT对吸毒者，特别是美沙酮维持治疗的吸毒者中HIV治疗成功的贡献，需要严格的数据。通过在提供艾滋病毒初级保健的美沙酮维持诊所进行HAART DOT的随机试验，我们将能够评估DOT的疗效和成本效益。这项建议的具体目标是：(1)在一项随机试验中，确定在24周的研究期间在美沙酮诊所现场提供的直接观察HAART是否比自我给予HAART更有效地降低HIV病毒载量和增加CD4细胞计数；(2)通过比较DOT组和自我给予组的长期依从性，使用自我报告和电子监测仪测量依从性，评估DOT作为一种增强依从性干预措施的持久性。(3)对直接观察到的HAART进行成本、成本抵消和成本效益分析。

DESCRIPTION (provided by applicant): Drug users account for a substantial proportion of AIDS cases; yet have received disproportionately less benefit from highly active antiretroviral therapy (HAART) than non-drug users. Recent reports have shown that HAART is under-utilized among drug users, and that persons with a history of injection drug use may be less likely to achieve the level of adherence necessary to maintain viral suppression than non-drug users. In order to improve both access to HAART and adherence among HIV-infected drug users, new models of integrated HIV-related and substance abuse treatment are rapidly evolving. One innovative model by which to deliver such treatment, provision of HIV primary care on-site in a methadone maintenance program has been shown to improve health outcomes in several studies. Directly observed therapy (DOT), effective in treating tuberculosis in methadone programs and other settings, is a logical extension of this model that has the potential to markedly enhance adherence with HAART. However, only preliminary findings from studies of the effectiveness of DOT for HIV have been reported, and these data are not consistent. While 80-100% of HIV DOT patients have achieved undetectable viral loads in some uncontrolled studies, other pilot DOT studies have found that the proportion achieving this outcome is 60-65%. In addition, DOT for HIV may paradoxically increase the risk of drug resistance by fostering moderate improvements in adherence. Rigorous data are necessary to judge the contribution of DOT to the success of HIV treatment among drug users, particularly among drug users in methadone maintenance treatment. By performing a randomized trial of HAART DOT in methadone maintenance clinics at which HIV primary care is provided, we will be able to evaluate the efficacy and cost-effectiveness of DOT. The specific aims of this proposal are: (1) To determine in a randomized trial whether directly observed HAART, provided on-site at a methadone clinic during a 24-week study period, is more effective than self-administered HAART for reducing HIV viral load and increasing CD4 count, (2) To assess the durability of DOT as an adherence-enhancing intervention by comparing long-term adherence in the DOT and self-administered groups, using self-report and electronic monitors to measure adherence 3, 6, and 12 months after DOT is discontinued, and (3) To perform cost, cost-offset, and cost-effectiveness analyses of directly observed HAART.