Managed problem solving: an HIV adherence trial

管理问题解决：艾滋病毒依从性试验

• 批准号: 7072269
• 负责人: ROBERT GROSS
• 金额: $ 51.03万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7072269
• 关键词: AIDS therapy; HIV infections; antiviral agents; behavioral /social science research tag; behavioral medicine; clinical research; clinical trials; cognitive behavior therapy; combination chemotherapy; data collection methodology /evaluation; depression; drug adverse effect; health behavior; helper T lymphocyte; human subject; human therapy evaluation; leukocyte count; longitudinal human study; memory; outcomes research; patient care management; problem solving; social support network; substance abuse related behavior; therapy compliance; virus load

DESCRIPTION (provided by applicant): Highly active antiretroviral therapy (HAART) is the cornerstone of treatment for Human Immunodeficiency Virus (HIV) infection. These treatments result in profound clinical improvement and prevent progression of disease. However, in order to be effective, the medication regimens must be rigorously adhered to over time. Studies by the investigative team and others have demonstrated clear associations between lower adherence and suboptimal treatment responses. Adherence research to date in HIV and other medical conditions suggests a variety of potential etiologies of poor adherence. Unfortunately, few interventions to improve adherence tested to date have been effective. The most promising interventions are flexible and multifactorial, targeting multiple potential barriers. We will conduct a randomized trial of a novel, pilot-tested, Social Cognitive Theory-based problem-solving derived adherence intervention, Managed Problem Solving (MAPS), in HIV infected individuals prescribed HAART. MAPS uses a 5-step process of problem orientation and definition, brainstorming for solutions to the identified barriers, selection and implementation of a plan of action, and assessment of implementation and feedback regarding its effectiveness. The intervention will address several potential adherence facilitators/barriers including linking medication taking with daily routines, medication reminders, refill reminders, and the involvement of social supports in medication taking in all subjects, and managing medication side effects, depression, substance abuse, competing demands, and psychoeducational barriers in a subset of subjects. Eligibility includes being equal to or >18 years of age and newly starting HAART or switching treatment due to lack of viral suppression. Two hundred subjects will be randomized 1:1 to the experimental or usual care groups. The experimental group will meet in person with an interventionist 4 times and by telephone 9 times over the first 3 months and then monthly by telephone for 9 months. Adherence will be monitored for both groups using microelectronic monitors (MEMS) and the intervention group will receive directed feedback on their adherence using these devices (virtual Directly Observed Therapy). The primary outcome will be adherence at 12 months and the secondary outcomes will be changes in viral load and CD4 counts at 12 months. If successful, this intervention will not only result in improved clinical outcomes in individuals who take part, but may also decrease the emergence of resistant HIV if incorporated into standard of care for HIV management.

描述（由申请人提供）：高度活跃的抗逆转录病毒疗法（HAART）是人类免疫缺陷病毒（HIV）感染治疗的基石。这些治疗可实现深刻的临床改善并预防疾病的进展。但是，为了有效，必须严格遵守药物治疗方案。调查团队和其他人的研究表明，较低的依从性与次优应答之间的关联。迄今为止，艾滋病毒和其他医疗状况的依从性研究表明，依从性差的各种潜在病因。不幸的是，迄今为止，很少有改善依从性的干预措施有效。最有希望的干预措施是灵活和多因素，针对多个潜在障碍。我们将对艾滋病毒感染的人开出的hiv感染者中的新颖，试验，社会认知理论的依从性干预，托管问题解决（MAP）的新颖，基于社会认知理论的随机试验。地图使用问题取向和定义的5步过程，用于针对确定障碍的解决方案，选择和实施行动计划以及对其有效性的实施和反馈的评估。该干预措施将解决一些潜在的依从性促进者/障碍，包括将药物服用与日常药物，药物提醒，补充提醒以及社会支持参与所有受试者的药物服用以及管理药物副作用，抑郁症，药物滥用，竞争需求以及受试者子集中的心理障碍。资格包括等于或> 18岁，以及由于缺乏病毒抑制而新开始HAART或切换治疗。将有200名受试者将1：1随机分为实验或通常的护理组。实验组将在前三个月内亲自见面4次，通过电话9次，然后每月通过电话9个月。将使用微电监测器（MEMS）对两组的依从性进行监控，并且干预组将使用这些设备（虚拟观察到的治疗）收到有关其依从性的指示反馈。主要结果将是在12个月的依从性，第二结果将是病毒载荷的变化和12个月的CD4计数。如果成功的话，这种干预不仅会导致参加的个体的临床结果改善，而且如果将HIV纳入HIV管理标准，也可能会减少抗性HIV的出现。