Developing an Antiretroviral Adherence Program in China

在中国制定抗逆转录病毒依从性计划

• 批准号: 7056653
• 负责人: Jane M. Simoni
• 金额: $ 16.71万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-20 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7056653
• 关键词: AIDS therapy; China; HIV infections; antiAIDS agent; behavior prediction; behavioral /social science research tag; clinical research; combination chemotherapy; culture; education evaluation /planning; focus groups; health care service planning; health education; human subject; interview; patient oriented research; social support network; therapy compliance

DESCRIPTION (provided by applicant): China is facing an HIV/AIDS crisis. Although treatment, including free medication, is increasingly available, reports of nonadherence are already surfacing. Within the current window of opportunity, there is an urgent need for research for the development of adherence enhancement programs, which will bolster the efficacy of the medication regimens and thwart the development and transmission of drug resistant virus. The proposed R34 application in response to PAR-03-078 involves a 3-year developmental project to design and pilot a culturally appropriate, clinical feasible, and generalizable program. This project is a multidisciplinary collaboration among experienced investigators at the University of Washington, expert consultants across the U.S., researchers from China's CDC, and care providers at Ditan Hospital in Beijing. The primary aims of the project are to (1) Conduct qualitative research including in-depth interviews and focus groups with patients, their family and caretakers, and providers to determine common barriers and likely facilitators to antiretroviral adherence, which will further guide intervention development; (2) Design a culturally sensitive and theoretically driven adherence program suitable for the Chinese HIV-Positive population, including development of an intervention manual and training materials; (3) Pilot test the program on 10 patients; and (4) After adjustments based on findings from the pilot, implement a preliminary randomized controlled trial (RCT) of 60 patients with 2 arms (minimal vs. enhanced intervention) to assess feasibility and initial efficacy. Although the exact nature of the intervention will depend upon findings from the qualitative phase of the project, research from studies based in the West as well as preliminary work in country suggest the potential acceptability and usefulness of a comprehensive program involving such components as informational group meetings, one-on-one psycho-educational counseling with nurses, DOT provided by family members, alarm reminders, and peer support.

描述（由申请人提供）：中国正面临艾滋病毒/艾滋病危机。尽管包括免费药物在内的治疗越来越多，但不遵守治疗的报告已经浮出水面。在当前的机会之内，迫切需要研究制定依从性增强计划，这将增强药物治疗方案的功效并阻止耐药病毒的发展和传播。响应 PAR-03-078 的拟议 R34 应用涉及一个为期 3 年的开发项目，旨在设计和试点文化上适当、临床可行且可推广的计划。该项目是华盛顿大学经验丰富的研究人员、美国各地的专家顾问、中国疾病预防控制中心的研究人员以及北京地坛医院的护理人员之间的多学科合作。该项目的主要目标是 (1) 进行定性研究，包括与患者、其家人和护理人员以及提供者进行深入访谈和焦点小组讨论，以确定抗逆转录病毒治疗依从性的常见障碍和可能的促进因素，这将进一步指导干预措施的制定； (2) 设计适合中国艾滋病毒阳性人群的具有文化敏感性和理论驱动的依从计划，包括制定干预手册和培训材料； (3) 在10名患者身上进行试点； (4) 根据试点结果进行调整后，对 60 名患者进行 2 组（最小干预与强化干预）的初步随机对照试验 (RCT)，以评估可行性和初步疗效。尽管干预的确切性质将取决于项目定性阶段的调查结果，但来自西方的研究以及国内的初步工作表明，涉及信息小组会议等组成部分的综合计划具有潜在的可接受性和有用性、护士一对一的心理教育咨询、家庭成员提供的DOT、警报提醒和同伴支持。