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)创建于2005年，目的是评估青少年和青少年前围产期获得性艾滋病毒感染的临床过程，以及在美国具有代表性的儿童队列中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450名围产期感染的青少年和青春期前儿童(青少年主协议，注册时年龄为7-16岁)的队列，以评估艾滋病毒和抗逆转录病毒治疗对性成熟、青春期发育和社交的影响；药物毒性监测系统(抗逆转录病毒毒性监测研究(SMARTT))招募了1,934名围产期感染艾滋病毒的未感染儿童，以评估宫内抗逆转录病毒治疗的长期影响。PHACS由一个科学领导小组(SLG)组成，该小组由一个协调中心、一个数据和运营中心(DOC)和24个临床站点监督。西雅特哈佛大学公共卫生学院的流行病学系和艾滋病生物统计研究中心(CBAR)和前沿科学基金会合作成立了PHACS DOC。DOC与SLG合作定义PHACS研究议程；为所有PHACS分析项目的开发提供方法学支持；合并来自先前队列(PACTG 219/219C、WITS、Legacy)的现有数据库的数据；维护临床现场分包以及培训和监测现场，以适当的程序进行PHACS研究；计划和举行所有领导层和完整的PHACS网络会议；并支持现役CAB。在PHACS II中，DOC将继续履行上述职责，同时完善其做法，并跟踪并将另外1,200-1,500名儿童纳入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。鉴于我们过去和现在的专业经验，我们处于独特的地位，可以提供科学/流行病学和操作领导，成功地开展PHACS。 公共卫生相关性：本申请书中描述的活动与公共卫生相关，因为它们将使公共卫生专业人员更好地了解产前使用抗逆转录病毒药物的风险以及艾滋病毒对青年和青少年发育的影响。这种增加的了解可随后转化为对受艾滋病毒/艾滋病影响的家庭提供更好的预防和治疗服务。

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.