Efficacy and cost of HAART DOT in methadone clinics

描述(申请人提供)：吸毒者占艾滋病病例的很大比例；但从高效抗逆转录病毒疗法(HAART)中获得的好处比非吸毒者少得不成比例。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。为了改善艾滋病毒感染的吸毒者获得抗逆转录病毒治疗和坚持抗逆转录病毒疗法的机会，与艾滋病毒相关的综合治疗和药物滥用治疗的新模式正在迅速演变。几项研究表明，提供这种治疗的一种创新模式--在美沙酮维持计划中现场提供艾滋病毒初级保健--可以改善健康结果。直接观察疗法(DOT)在美沙酮计划和其他环境中有效地治疗结核病，是这一模式的合理扩展，有可能显著提高对HAART的依从性。然而，关于DOT治疗艾滋病毒有效性的研究只有初步结果被报道，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患者获得了无法检测到的病毒载量，但其他试点DOT研究发现，实现这一结果的比例为60%-65%。此外，艾滋病毒的DOT可能会通过促进依从性的适度改善而矛盾地增加耐药风险。需要严格的数据来判断DOT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。通过在提供艾滋病毒初级护理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。这项建议的具体目的是：(1)在随机试验中确定在24周的研究期间在美沙酮诊所现场提供的直接观察的HAART在减少HIV病毒载量和增加CD4计数方面是否比自我给药HAART更有效，(2)通过比较DOT组和自我给药组的长期依从性，使用自我报告和电子监测器测量DOT停止后3、6和12个月的依从性，以及(3)进行成本、成本抵消，直接观察HAART的成本-效果分析。

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.