PHACS - Data and Operations Center

描述（由申请人提供）：了解青少年和青春期前围产期获得性HIV感染的临床过程，以及胎儿和新生儿暴露于HIV和抗逆转录病毒化疗的后果，在美国的一组有代表性的儿童中提供了一个独特的科学机会。认识到这一机会，国家儿童健康和人类发展研究所（NICHD）打算建立儿童艾滋病毒/艾滋病队列研究（PHACS），在两个队列中进行研究：将建立围产期感染的青少年和青春期前（7-18岁）队列，以评估艾滋病毒和抗逆转录病毒治疗对性成熟、青春期发育和社会化的影响，并在围产期感染艾滋病毒的未感染儿童中建立药物毒性监测系统，以评估子宫内抗逆转录病毒治疗的长期影响。PHACS将由一个科学领导小组（SLG）、一个数据和运营中心（DOC）以及多达20个PHACS临床研究者站点组成。哈佛大学公共卫生、西部和前沿科学学院的流行病学系和艾滋病研究生物统计中心（CBAR）将合作建立PHACS DOC。除了合作确定PHACS研究议程外，在第一年，pi将为所有PHACS分析项目的开发提供方法学支持，开发（基础和未感染的）核心协议，开发和支持有效的CAB，编写和管理站点招标，建立站点分包合同，从以前的队列（PACTG 219/219C， WITS， PSD）获取和合并所有预先存在的数据库，并计划和主持所有LG和完整的PHACS网络会议。在第2-5年，他们将继续为PHACS研究方案的发展提供设计、方法和分析专业知识和支持；在PHACS研究的适当程序方面培训和监测站点。HSPH/CBAR、Westat和Frontier Science在提供PHACS所需的方法和操作支持方面有着悠久的历史，以及提高和最大化PHACS研究设计、实施和分析效率的创新方法。鉴于他们之前和目前的专业经验，pi希望能够在科学和流行病学方面发挥独特的领导作用，成功开展PHACS。

DESCRIPTION (provided by applicant): Understanding the clinical course of perinatally acquired HIV infection among adolescents and preadolescents, and the consequences of fetal and neonatal exposure to HIV and antiretroviral chemotherapy among a representative cohort of children in the United States presents a unique scientific opportunity. Recognizing this opportunity, the National Institutes of Child Health and Human Development (NICHD) intends to establish the Pediatric HIV/AIDS Cohort Study (PHACS) to conduct research among two cohorts: A cohort of perinatally infected adolescents and preadolescents (age 7-18) will be established to evaluate the impact of HIV and ART on sexual maturation, pubertal development, and socialization, and a drug toxicity surveillance system among perinatally HIV exposed uninfected children will evaluate long-term effects of in-utero ART exposure. PHACS will be comprised of a Scientific Leadership Group (SLG), a Data and Operations Center (DOC), and up to 20 PHACS Clinical Investigator Sites. The Departments of Epidemiology and the Center for Biostatistics in AIDS Research (CBAR) at the Harvard School of Public Health, Westat and Frontier Science will collaborate to form the PHACS DOC. In addition to collaborating to define the PHACS research agenda, during year 1 the PIs will provide methodological support for the development of all PHACS analytic projects, develop the (base and uninfected) core protocols, develop and support an active CAB, write and manage a site solicitation, establish site sub-contracts, obtain and merge all preexisting data bases from previous cohorts (PACTG 219/219C, WITS, PSD), and plan and conduct all LG and full PHACS Network Meetings. In years 2-5, they will continue to provide design, methodological, and analytical expertise and support to the development of PHACS research protocols; and train and monitor sites in proper procedures for PHACS research. Together, HSPH/CBAR, Westat and Frontier Science bring long histories of providing the type of methodological and operational support required by the PHACS, as well as innovative methods to enhance and maximize the efficiency of PHACS study design, conduct, and analysis. Given their prior and current professional experience, the PIs expect to be uniquely positioned to provide the scientific and epidemiologic leadership to successfully conduct the PHACS.