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。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22个临床单位（CU）监督。流行病学系和Westat的哈佛公共卫生学院的艾滋病研究生物统计中心以及前沿科学基金会组成了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领导;维护CU分包合同，并在PHACS研究的适当程序中培训和监测站点;计划和举办所有领导和全面PHACS网络会议;为PHACS社区开发与艾滋病毒和健康相关的教育材料和机会;并支持一个活跃的社区咨询委员会。青少年主协议（AMP），一个队列的450围产期艾滋病毒感染的青少年和青春期前7-16岁的登记，建立了调查艾滋病毒和ART对器官系统，生长和发育，性成熟，青春期发育，认知，情感发展和社会化的影响; AMP Up随后被设计为使用简化的移动友好协议扩展AMP参与者和其他年满18岁的艾滋病毒感染年轻人的随访。一个药物毒性监测系统-抗逆转录病毒毒性监测系统（SMART）-已经招募了3，506名围产期接触艾滋病毒、未感染的儿童，以评估宫内接触抗逆转录病毒药物的长期影响。在PHACS III中，DOC将继续以越来越有效的方式执行PHACS科学议程，将另外1，000名新生儿纳入SMARTT，并将另外525名艾滋病毒感染者和艾滋病毒暴露者，未感染的年轻人纳入AMP Up。HSPH，Westat和Frontier Science共同带来了提供PHACS所需的科学和运营领导的悠久而成功的历史，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。鉴于我们之前的经验，我们处于独特的地位，继续提供必要的科学/流行病学和业务领导PHACS的持续成功。

 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. PHACS is comprised of a Scientific Leadership Group (SLG), which is overseen by a Coordinating Center, a Data and Operations Center (DOC), and 22 clinical units (CU). The Department of Epidemiology and the Center for Biostatistics in AIDS Research at the Harvard School of Public Health, Westat, and the Frontier Science Foundation form the PHACS DOC. The DOC collaborates with the SLG to define the PHACS research agenda; provides methodological leadership for the development of all PHACS analytic projects; maintains CU subcontracts and trains and monitors sites in proper procedures for PHACS research; plans and conducts all leadership and full PHACS network meetings; develops HIV- and health- related educational materials and opportunities for the PHACS community; and, supports an active Community Advisory Board. The Adolescent Master Protocol (AMP), a cohort of 450 perinatally HIV-infected adolescents and preadolescents age 7-16 at enrollment, was established to investigate the impact of HIV and ART on organ systems, growth and development, sexual maturation, pubertal development, cognition, emotional development, and socialization; AMP Up was subsequently designed to extend follow-up of AMP participants and other HIV-infected young adults who have reached 18 years of age using a streamlined, mobile-friendly protocol. A drug toxicity surveillance system, Surveillance Monitoring for Anti-Retroviral Toxicities (SMART), has enrolled 3,506 perinatally HIV-exposed, uninfected children to evaluate long-term effects of in-utero ART exposure. In PHACS III, the DOC will continue to carry out the PHACS scientific agenda in an increasing efficient manner, enrolling and following an additional 1,000 newborns into SMARTT and an additional 525 HIV-infected and HIV-exposed, uninfected young adults into AMP Up. Together, HSPH, Westat and Frontier Science bring a long and successful history of providing the scientific and operational leadership required by PHACS, as well as innovative methods to enhance and maximize the efficiency of the PHACS study design, conduct, and analyses. Given our prior experience we are uniquely positioned to continue to provide the scientific/epidemiologic and operational leadership essential to the continued success of PHACS.