Center for the Analysis & Management of the Multicenter AIDS Cohort Study

分析中心

• 批准号: 7725473
• 负责人: LISA P JACOBSON
• 金额: $ 251.09万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-25 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7725473
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adverse effects; Behavior; Biology; Clinical; Cohort Studies; Communication; Control Groups; Data; Data Coordinating Center; Development; Disease; Documentation; Epidemiology; Equilibrium; Genetic; HIV; HIV Infections; HIV vaccine; Highly Active Antiretroviral Therapy; Immunologics; Infection; Infection prevention; Leadership; Life; Life Style; Methodology; Methods; Natural History; Outcome; Participant; Population; Positioning Attribute; Protocols documentation; Research; Research Design; Research Personnel; Science; Site; Specimen; System; age effect; data management; demographics; design; experience; follow-up; insight; men; organizational structure; psychosocial; repository; response; statistics

The Multicenter AIDS Cohort Study (MACS), a comprehensive cohort study ongoing since 1984, has contributed to the understanding of the natural history of HIV infection and the impact of highly active antiretroviral therapies (HAART). Combining genetic, virologic, immunologic and psychosocial approaches and utilizing the repository of specimens and long-term characterization of the participants, the extension of the support of the MACS will allow further elucidation of the biology of and response to HIV infection in the absence and presence of therapies, and distinguishing the effects of age, HIV and HAART on clinical outcomes. The MACS is ideally positioned to address these issues because of long-term standardized follow-up of 6,972 men, an extensive specimen repository and an appropriate control group consisting of HIV uninfected men with similar lifestyle behaviors and demographics. Additional strengths include following over 653 men before and after infection and with known dates of infection, experienced investigators and a broad network of outstanding collaborators with expertise in all aspects of HIV disease. This application further seeks support for the extension of the Center for the Analysis and Management of the MACS Data (CAMACS) to provide epidemiologic and statistical leadership to the MACS research agenda. The multicenter collaborative aspect, the complexities of characterizing the balance between beneficial and adverse effects of therapies, the selective use of treatment and the challenges inherent in choosing efficient study designs appropriate to the research questions require an analytical center to integrate HIV science with expertise in epidemiology, statistics and data management for MACS to successfully address the scientific aims as stated in Part A of this application. The specific aims of CAM ACS are to provide leadership and quality-assured systems to: 1) coordinate the research initiatives (includes effective communication, study protocol and form revision, periodic presentation of statistical characterizations pertinent to the scientific agenda); 2) manage the data to facilitate analyses (includes edit, documentation, storage, and dissemination); 3) provide statistical and epidemiological expertise in the design, analysis and interpretation of studies and to develop statistical and epidemiologic methodology; and 4) promote and track the use of MACS data/specimens.

多中心艾滋病队列研究（MACS）是一项自1984年以来一直在进行的综合性队列研究， 了解艾滋病毒感染的自然史和高效抗逆转录病毒药物的影响 HAART（HAART）。结合遗传学、病毒学、免疫学和社会心理学方法， 标本和参与者的长期表征库，支持的扩展， MACS将允许进一步阐明HIV感染的生物学和反应，在缺乏和存在的情况下， 的治疗，并区分年龄，艾滋病毒和HAART对临床结果的影响。MACS是理想的 由于对6,972名男性进行了长期标准化随访， 样本库和适当的对照组，由生活方式相似的未感染HIV的男性组成 行为和人口统计学。其他优势包括在感染前后跟踪超过653名男性， 感染日期已知，经验丰富的研究人员和广泛的杰出合作者网络， 在艾滋病毒疾病的各个方面的专业知识。本申请进一步寻求对中心扩展的支持， MACS数据分析和管理（CAMACS），为以下方面提供流行病学和统计学领导： MACS研究议程。多中心协作方面，表征平衡的复杂性 治疗的有利和不利影响之间，选择性使用治疗和固有的挑战， 选择适合研究问题的有效研究设计需要一个分析中心来整合 艾滋病毒科学与流行病学，统计和数据管理的专业知识，为MACS成功地解决 如本申请A部分所述的科学目的。CAM ACS的具体目标是提供领导和 质量保证系统：1）协调研究活动（包括有效的沟通，研究 方案和表格修订，定期提交与科学研究有关的统计特征， 议程）; 2）管理数据以促进分析（包括编辑、记录、存储和传播）; 3） 在研究的设计、分析和解释方面提供统计和流行病学专门知识， 发展统计学和流行病学方法; 4）促进和跟踪MACS数据/标本的使用。