BETTER ANTIRETROVIRAL ADHERENCE: HIV+ AMPHETAMINE USERS

更好的抗逆转录病毒治疗依从性：HIV 安非他明使用者

• 批准号: 6378944
• 负责人: JOSEPH H ATKINSON
• 金额: $ 30.69万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-08-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6378944
• 关键词: AIDS therapy; HIV infections; amphetamines; antiAIDS agent; antiviral agents; behavior therapy; clinical research; clinical trials; drug abuse therapy; human subject; human therapy evaluation; intravenous drug abuse; therapy compliance; urinalysis

DESCRIPTION: (Adapted from Applicant's Abstract) Concern about adherence to anti-retroviral therapy is at the forefront of HIV care. This concern is paramount in methamphetamine and other drug-dependent individuals, who are at high risk for non-adherence. Restriction in use of newer therapies is a common response among HIV clinicians, at least until there is stable abstinence from drugs, but relapse rates are high and few data are available to guide therapeutic efforts. This study has two objectives. First, to conduct a three-arm randomized clinic trial comparing the efficacy of Usual Medical Care to two alternatives for facilitating adherence to anti-retrovirals in HIV-infected, methamphetamine-dependent persons in early recovery. One intervention is Adherence Training alone, and the other combines Adherence Training with Stimulant Relapse Prevention. The second objective is to relate adherence to neurocognitive status, anti-retroviral experience, life adversity, psychiatric disorder and substance use. The proposed Adherence and Stimulant Relapse Prevention Interventions are based on the Information-Motivation-Behavioral Skills Model (IMB). Subjects (N=75 in each arm) will be randomized into eight weeks of Usual Medical Care, or into either of two experimental treatments (Adherence Training + Usual Care vs. Adherence Training + Stimulant Relapse Prevention + Usual Care). Efficacy will be determined at conclusion of treatment (e.g., 2 months post-baseline), and four and six months post-baseline. At baseline, end of treatment, and four and six months after baseline the investigators will measure self-report adherence, HIV RNA, urine toxicology, substance use, life quality, and neuropsychiatric status. Adherence to anti-retrovirals will be measured by continuous electronic monitoring (Medication Event Monitoring System-MEMS), and serum anti-retroviral drug concentrations. The investigators hypothesize that Adherence Training + Relapse Prevention will outperform Adherence Training, and Adherence Training will outperform Usual Care. They hypothesize that neurocognitive impairment and stimulant use will predict non-adherence, as will antisocial personality disorder, mood disorder, antisocial personality, and substance use predict non-adherence, and subsequent elevated plasma HIV RNA and reduced life quality.

描述：（改编自申请人的摘要）关注遵守 抗逆转录病毒疗法是艾滋病毒护理的前沿。这种担忧是 最重要的甲基苯丙胺和其他药物依赖的个人，谁是在 不遵守的高风险。限制使用较新的疗法是一种常见的 艾滋病毒临床医生的反应，至少在有稳定的禁欲， 药物，但复发率很高，很少有数据可以指导 治疗的努力。本研究有两个目的。第一，进行 三组随机临床试验，比较家庭医疗护理的疗效 两种选择，以促进坚持抗逆转录病毒药物， 艾滋病毒感染者、甲基苯丙胺依赖者在早期康复中。一 一种是单独的坚持训练，另一种是结合坚持训练。 使用兴奋剂预防复发。第二个目标是联系 坚持神经认知状态、抗逆转录病毒经历、生活逆境， 精神障碍和物质使用。 建议的依从性和刺激复发预防干预措施是基于 信息动机行为技能模型（IMB）受试者（N=75， 每组）将被随机分为8周的家庭医疗护理组，或 两种实验性治疗（依从性训练+口腔护理vs. 坚持训练+刺激复发预防+精神护理）。功效将 在治疗结束时确定（例如，基线后2个月），以及 基线后4个月和6个月。 在基线、治疗结束时以及基线后4个月和6个月， 研究人员将测量自我报告的依从性，HIV RNA，尿液毒理学， 物质使用、生活质量和神经精神状态。遵守 抗逆转录病毒药物将通过连续电子监测进行测量 （药物事件监测系统-MEMS）和血清抗逆转录病毒药物 浓度的研究人员假设坚持训练+复发 预防将优于坚持培训，坚持培训将 优于医疗保健。他们假设神经认知障碍和 使用兴奋剂和反社会人格可以预测不依从性 精神障碍、情绪障碍、反社会人格和物质使用预测 不依从，随后血浆HIV RNA升高，生活质量下降。