DAART+ AS A STRUCTURAL HIV INTERVENTION IN METHADONE MAINTENANCE

描述(申请人提供)：抗逆转录病毒(ARV)坚持被证明是困难的许多艾滋病毒阳性患者的药物使用障碍。不坚持治疗会导致治疗反应差、病毒耐药、交叉耐药和耐药病毒株的传播。在结核病直接观察疗法(DOT)的基础上，直接实施的抗逆转录病毒疗法(DAART)在有干预措施的情况下改善了药物滥用者的健康结果(Conway等人，2004年；Lucas等人，2004年)。美沙酮维持治疗(MMT)是DAART的理想设置，因为它需要患者和医疗保健提供者之间频繁接触。这项第1阶段的治疗开发计划将试验和评估一种针对MMT患者的创新的增强型DAART(DAART+)干预措施，以促进长期、自主的抗逆转录病毒疗法的坚持。DAART+在理论上以坚持的信息-动机-行为技能模型(1MB)为基础，并扩展了传统的DAART模式，包括结构和个人层面的组成部分，包括对临床政策的行政修改，以支持提供抗逆转录病毒药物、工作人员艾滋病毒教育、临床药剂师对患者的依从性咨询和逐渐减少的DAART+方法。这项研究将包括：(1)为期4个月的开发阶段，以完善和标准化DAART+的治疗手册、结果衡量标准和结构组成部分；(2)为期20个月的试点干预阶段，以收集关于DAART+在改善用药依从性和降低HIV-1 RNA病毒载量方面的有效性的初步数据。该设计是一种修改的、中断的时间序列移除，包括6个月的DAART+，3个月的DAART+渐进式缩减和3个月的随访，而不使用DAART+。我们将检查物质使用和抑郁症状，作为坚持的调节因素。作为一个新的研究人员，R21机制允许独立的地位，并为未来R01临床试验的发展提供重要的研究培训和试点数据。将艾滋病毒/艾滋病服务与药物滥用治疗联系起来是一项重要的公共卫生干预措施，有可能推动这两个领域的发展。此外，抗逆转录病毒依从性的提高与艾滋病毒阳性患者治疗费用的大幅下降以及机会性感染发生率、医院利用率和抗逆转录病毒耐药株的开发有关。

DESCRIPTION (provided by applicant): Anti retroviral (ARV) adherence proves difficult for many HIV-positive patients with substance use disorders. Non-adherence results in poor response to therapy, viral drug resistance, cross-resistance and the spread of drug-resistant viral strains. Based on Directly Observed Therapy (DOT) for the treatment of tuberculosis, Directly Administered Antiretroviral Therapy (DAART) improves health outcomes among substance-abusers while the intervention is present (Conway et al., 2004; Lucas et al., 2004). Methadone maintenance treatment (MMT) is an ideal setting for DAART because it requires frequent contact between patients and health care providers. This Stage 1 treatment development proposal will pilot and evaluate an innovative enhanced DAART (DAART+) intervention for MMT patients to promote long-term, autonomous antiretroviral regimen adherence. DAART+ is theoretically grounded in the Information-Motivation-Behavior Skills model (1MB) of adherence and extends the traditional DAART model with both structural and individual-level components including the administrative modification of clinic policies to support the provision of antiretroviral medication, staff HIV education, patient adherence counseling by a clinical pharmacist and tapered DAART+ methods. The study will consist of: (1) a 4-month developmental phase to refine and standardize the treatment manual, outcome measures and structural components of DAART+ and; (2) a 20- month pilot intervention phase to collect preliminary data on the effectiveness of DAART+ in improving medication adherence and reducing HIV-1 RNA viral load. The design is a modified, interrupted time-series removal with 6-months of DAART+, a 3-month gradual DAART+ taper and a 3-month follow-up without DAART+. We will examine substance use and depressive symptoms as moderators of adherence. As a new investigator, the R21 mechanism allows for independent status and provides significant research training and pilot data for the development of a future R01 clinical trial. Linking HIV/AIDS services with substance abuse treatment is an important public health intervention with potential to advance both fields. Moreover, increased antiretroviral adherence is associated with a large decrease in the cost of treatment for HIV-positive patients, as well as a decrease in the incidence of opportunistic infections, hospital utilization and the development of antiretroviral-resistant strains.