DAART+ AS A STRUCTURAL HIV INTERVENTION IN METHADONE MAINTENANCE

DAART 作为美沙酮维持治疗中的结构性艾滋病毒干预措施

• 批准号: 7119799
• 负责人: James L Sorensen
• 金额: $ 23.03万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7119799
• 关键词: AIDS; RNA; clinical research; clinical trials; counseling; drug resistance; methadone; model; motivation; reduction; substance abuse related disorder; training; tuberculosis

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.

描述（由申请人提供）：抗逆转录病毒（ARV）的坚持证明了许多艾滋病毒阳性的物质使用障碍患者的困难。非依从性导致对治疗的不良反应、病毒耐药性、交叉耐药性和耐药性病毒株的传播。基于用于治疗结核病的直接观察疗法（DOT），直接施用抗逆转录病毒疗法（DAART）在存在干预时改善物质滥用者的健康结果（Conway等人，2004; Lucas等人，2004年）。美沙酮维持治疗（MMT）是DAART的理想环境，因为它需要患者和医疗保健提供者之间的频繁接触。该第1阶段治疗开发提案将对MMT患者的创新增强DAART（DAART+）干预进行试点和评估，以促进长期自主抗逆转录病毒治疗方案的依从性。DAART+理论上基于信息-动机-行为技能模型（1 MB）的依从性，并扩展了传统的DAART模型，包括结构和个人层面的组件，包括对诊所政策的行政修改，以支持提供抗逆转录病毒药物，员工艾滋病毒教育，临床药剂师的患者依从性咨询和锥形DAART+方法。研究将包括：（1）4个月的开发阶段，以完善和标准化DAART+的治疗手册、结局指标和结构组件;（2）20个月的试点干预阶段，以收集DAART+在改善药物依从性和降低HIV-1 RNA病毒载量方面有效性的初步数据。该设计是一种改良的、中断的时间序列移除，6个月的DAART+，3个月的渐进式DAART+逐渐减少，3个月的随访没有DAART+。我们将研究物质使用和抑郁症状作为依从性的调节因子。作为新的研究者，R21机制允许独立的身份，并为未来R 01临床试验的开发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，坚持抗逆转录病毒治疗的人数增加，艾滋病毒抗体阳性患者的治疗费用大幅下降，机会性感染的发生率、医院利用率和抗逆转录病毒耐药菌株的形成也随之减少。