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

描述（由申请人提供）：儿科艾滋病毒/艾滋病队列研究 (PHACS) 于 2005 年创建，旨在评估美国代表性儿童队列中青少年和青春期前儿童围产期获得艾滋病毒感染的临床过程，以及胎儿和新生儿接触艾滋病毒和抗逆转录病毒化疗的后果。建立了一个由 450 名围产期感染青少年和青春期前青少年（AMP，入组时年龄 7-16 岁）组成的队列，以评估 HIV 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（抗逆转录病毒毒性研究监测 (SMARTT)）招募了 1,934 名围产期 HIV 暴露的未感染儿童，以评估宫内 ART 暴露的长期影响。PHACS 由科学领导小组 (SLG) 组成，由协调中心、数据和运营中心 (DOC) 和 24 个临床中心监督。哈佛大学公共卫生学院艾滋病生物统计学中心 (CBAR)、Westat 和前沿科学基金会合作组建 PHACS DOC。DOC 与 SLG 合作制定 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（PACTG 219/219C、WITS、Legacy）；按照适当的程序分包、培训和监控 PHACS 研究中心；规划并开展所有领导会议和完整的 PHACS 网络会议；在 PHACS II 中，DOC 将继续履行上述职责，同时完善其实践，并跟踪并招募另外 1,200-1,500 名儿童加入 SMARTT。 PHACS 以及提高和最大限度提高 PHACS 研究设计、实施和分析效率的创新方法 鉴于我们之前和当前的专业经验，我们具有独特的优势，可以为成功开展 PHACS 提供科学/流行病学和运营领导。

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.