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;但与非吸毒者相比，他们从高效抗逆转录病毒治疗（HAART）中获得的益处不成比例地少。最近的报告表明，HAART在吸毒者中使用不足，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依从性水平。为了改善受艾滋病毒感染的吸毒者获得高效抗逆转录病毒疗法的机会和坚持治疗的情况，正在迅速发展与艾滋病毒有关的药物滥用综合治疗的新模式。一个创新的模式，提供这种治疗，提供艾滋病毒的初级保健现场美沙酮维持计划已被证明可以改善健康结果在几项研究。直接观察治疗（DOT），有效地治疗结核病的美沙酮计划和其他设置，是一个合乎逻辑的延伸，这种模式，有可能显着提高坚持HAART。然而，只有DOT对HIV有效性研究的初步结果被报道，这些数据并不一致。虽然在一些非对照研究中，80-100%的HIV DOT患者达到了不可检测的病毒载量，但其他试点DOT研究发现，达到这一结果的比例为60- 65%。此外，DOT治疗HIV可能通过促进依从性的适度改善而矛盾地增加耐药性的风险。 必须有严格的数据来判断直接观察治疗对吸毒者，特别是美沙酮维持治疗吸毒者艾滋病毒治疗成功的贡献。通过在提供艾滋病初级保健的美沙酮维持治疗诊所进行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）在随机试验中确定在美沙酮诊所现场提供的24周研究期间直接观察的HAART是否比自我施用的HAART更有效地降低HIV病毒载量和增加CD 4计数，（2）通过比较DOT组和自我给药组的长期依从性，评估DOT作为依从性增强干预措施的持久性，使用自我报告和电子监测器，以衡量坚持3，6和12个月后，DOT是中断，和（3）进行成本，成本抵消，成本效益分析直接观察HAART。

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.