Pediatric HIV/AIDS Cohort Study (PHACS) Data and Operations Center (DOC)

描述（由申请人提供）：儿科HIV/AIDS队列研究（PHACS）创建于2005年，旨在评估美国一组具有代表性的儿童队列中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。建立了450名围产期感染的青少年和前青少年队列（青少年主方案，AMP，入组时年龄为7-16岁），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；药物毒性监测系统（抗逆转录病毒毒性监测研究（SMARTT））招募了1934名围产期接触艾滋病毒的未感染儿童，以评估子宫内接触抗逆转录病毒药物的长期影响。PHACS由一个科学领导小组（SLG）组成，该小组由一个协调中心、一个数据和操作中心（DOC）以及24个临床站点监督。哈佛大学公共卫生学院流行病学系和艾滋病研究生物统计中心（CBAR）与前沿科学基金会合作形成了PHACS DOC。DOC与SLG合作确定PHACS的研究议程；为所有PHACS分析项目的开发提供方法上的支持；合并先前队列中已有数据库的数据（PACTG 219/219C、WITS、Legacy）；维护临床场地分包合同，培训和监督场地进行PHACS研究的适当程序；计划和主持所有领导会议和PHACS全网会议；并且，支持活动CAB。在PHACS II中，商务部将继续履行上述职责，同时改进其做法，并跟进并招收额外的1,200-1,500名儿童进入SMARTT。HSPH、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，以及创新的方法来提高和最大限度地提高PHACS研究设计、实施和分析的效率。鉴于我们之前和目前的专业经验，我们具有独特的优势，可以提供科学/流行病学和业务领导，以成功开展PHACS。

DESCRIPTION (provided by applicant): The Pediatric HIV/AIDS Cohort Study (PHACS) was created in 2005 to evaluate the clinical course of perinatally acquired HIV infection among adolescents and pre-adolescents and the consequences of fetal and neonatal exposure to HIV and antiretroviral chemotherapy among a representative cohort of children in the United States. A cohort of 450 perinatally infected adolescents and preadolescents (Adolescent Master Protocol, AMP, age 7-16 at enrollment) was established to evaluate the impact of HIV and ART on sexual maturation, pubertal development, and socialization; and, a drug toxicity surveillance system (Surveillance Monitoring for Anti-Retroviral Toxicities Study (SMARTT) enrolled 1,934 perinatally HIV exposed uninfected children to evaluate long-term effects of in-utero ART exposure. PHACS is comprised of a Scientific Leadership Group (SLG), which is overseen by a Coordinating Center, a Data and Operations Center (DOC), and 24 clinical sites. The Department of Epidemiology and the Center for Biostatistics in AIDS Research (CBAR) at the Harvard School of Public Health, Westat, and the Frontier Science Foundation collaborate to form the PHACS DOC. The DOC collaborates with the SLG to define the PHACS research agenda; provides methodological support for the development of all PHACS analytic projects; merges data from pre-existing databases from previous cohorts (PACTG 219/219C, WITS, Legacy); maintains clinical site subcontracts and trains and monitors sites in proper procedures for PHACS research; plans and conducts all leadership and full PHACS network meetings; and, supports an active CAB. In PHACS II, the DOC will continue the duties described above while refining its practices, as well as follow and enroll an additional 1,200-1,500 children into SMARTT. Together, HSPH, Westat and Frontier Science bring long histories of providing the type of methodologic and operational support required by PHACS, as well as innovative methods to enhance and maximize the efficiency of PHACS study design, conduct, and analysis. Given our prior and current professional experience, we are uniquely positioned to provide the scientific/epidemiologic and operational leadership to successfully conduct PHACS. PUBLIC HEALTH RELEVANCE: The activities described in this application are relevant to public health in that they will provide public health professionals with an increased understanding of the risks of antiretroviral use in the prenatal period and the affects of HIV on the development of youth and adolescents. This increased understanding can subsequently translate into improved prevention and treatment services for families affected by HIV/AIDS.