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，旨在评价美国一个代表性儿童队列中青少年和青春期前围产期获得性HIV感染的临床病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。450例围产期感染青少年和青春期前感染者的队列研究（青少年主协议，AMP，年龄7-16在登记），以评估艾滋病毒和ART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）入组1例，934例围产期暴露于HIV的未感染儿童，以评估宫内ART暴露的长期影响。PHACS由一个科学领导小组（SLG）组成，由一个协调中心、一个数据和运营中心（DOC）和24个临床中心监督。Westat的哈佛公共卫生学院的流行病学系和艾滋病研究生物统计学中心（CBAR）以及前沿科学基金会合作成立了PHACS DOC。DOC与SLG合作确定PHACS研究议程;为所有PHACS分析项目的开发提供方法支持;合并来自先前队列的现有数据库的数据（PACTG 219/219 C，WITS，Legacy）;维护临床研究中心分包合同，培训和监测研究中心的PHACS研究程序;计划和举办所有领导和全面PHACS网络会议;并且支持活动CAB。在PHACS II中，DOC将继续履行上述职责，同时改进其做法，并跟踪和招收另外1，200 - 1，500名儿童进入SMARTT。HSPH，Westat和Frontier Science共同带来了提供PHACS所需的方法和操作支持类型的悠久历史，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/流行病学和运营领导，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.