PHACS - Data and Operations Center

PHACS - 数据和运营中心

• 批准号: 7675456
• 负责人: George R Seage
• 金额: $ 1403.96万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7675456
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adolescent; Age; Agreement; Anti-Retroviral Agents; Biometry; Boston; Centers for Disease Control and Prevention (U.S.); Child; Clinical; Clinical Investigator; Clinical Trials Data Monitoring Committees; Cohort Studies; Communities; Contracts; Data; Data Collection; Databases; Development; Drug toxicity; Enrollment; Epidemiologist; Epidemiology; Exposure to; Foundations; HIV; HIV Infections; Infant; Leadership; Long-Term Effects; Manuals; Methods; Monitor; National Institute of Child Health and Human Development; Newborn Infant; Operative Surgical Procedures; Outcome; Population; Positioning Attribute; Preventive; Principal Investigator; Procedures; Protocols documentation; Public Health Schools; Quality Control; Recording of previous events; Recruitment Activity; Research; Research Design; Research Personnel; Safety; Science; Sexual Maturation; Site; Socialization; Source; Study Subject; System; Technology; Training; United States; Universities; Writing; antiretroviral therapy; base; chemotherapy; cohort; cost; data management; design; experience; fetal; frontier; in utero; innovation; meetings; member; neonatal exposure; pediatric human immunodeficiency virus; performance site; programs; quality assurance

DESCRIPTION (provided by applicant): Understanding the clinical course of perinatally acquired HIV infection among adolescents and preadolescents, and the consequences of fetal and neonatal exposure to HIV and antiretroviral chemotherapy among a representative cohort of children in the United States presents a unique scientific opportunity. Recognizing this opportunity, the National Institutes of Child Health and Human Development (NICHD) intends to establish the Pediatric HIV/AIDS Cohort Study (PHACS) to conduct research among two cohorts: A cohort of perinatally infected adolescents and preadolescents (age 7-18) will be established to evaluate the impact of HIV and ART on sexual maturation, pubertal development, and socialization, and a drug toxicity surveillance system among perinatally HIV exposed uninfected children will evaluate long-term effects of in-utero ART exposure. PHACS will be comprised of a Scientific Leadership Group (SLG), a Data and Operations Center (DOC), and up to 20 PHACS Clinical Investigator Sites. The Departments of Epidemiology and the Center for Biostatistics in AIDS Research (CBAR) at the Harvard School of Public Health, Westat and Frontier Science will collaborate to form the PHACS DOC. In addition to collaborating to define the PHACS research agenda, during year 1 the PIs will provide methodological support for the development of all PHACS analytic projects, develop the (base and uninfected) core protocols, develop and support an active CAB, write and manage a site solicitation, establish site sub-contracts, obtain and merge all preexisting data bases from previous cohorts (PACTG 219/219C, WITS, PSD), and plan and conduct all LG and full PHACS Network Meetings. In years 2-5, they will continue to provide design, methodological, and analytical expertise and support to the development of PHACS research protocols; and train and monitor sites in proper procedures for PHACS research. Together, HSPH/CBAR, Westat and Frontier Science bring long histories of providing the type of methodological and operational support required by the PHACS, as well as innovative methods to enhance and maximize the efficiency of PHACS study design, conduct, and analysis. Given their prior and current professional experience, the PIs expect to be uniquely positioned to provide the scientific and epidemiologic leadership to successfully conduct the PHACS.

描述（由申请人提供）：了解青少年和前群落中周围获得的HIV感染的临床过程，以及在美国代表性的儿童中，胎儿和新生儿暴露于HIV和抗逆转录病毒化疗的后果提出了独特的科学机会。国家儿童健康与人类发展机构（NICHD）旨在建立小儿艾滋病毒/艾滋病队列研究（PHACS），以在两个同类群体之间进行研究：围绕周围感染的青少年和preadolectents（7-18岁）进行研究，以评估HIV和ART对性的影响，并将其对ART的影响建立性，并将其用于评估HIV和ART的影响，并将其用于评估HIV和ART的影响。周围艾滋病毒暴露的未感染儿童的监视系统将评估UTERO内艺术暴露的长期影响。 PHAC将由一个科学领导力小组（SLG），数据和运营中心（DOC）以及多达20个PHACS临床研究者站点组成。哈佛大学公共卫生学院，Westat和Frontier Science的流行病学和艾滋病研究（CBAR）生物统计学中心将合作组建PHACS DOC。 In addition to collaborating to define the PHACS research agenda, during year 1 the PIs will provide methodological support for the development of all PHACS analytic projects, develop the (base and uninfected) core protocols, develop and support an active CAB, write and manage a site solicitation, establish site sub-contracts, obtain and merge all preexisting data bases from previous cohorts (PACTG 219/219C, WITS, PSD), and plan and进行所有LG和完整的PHAC网络会议。 在2 - 5年内，他们将继续为PHACS研究方案的开发提供设计，方法论和分析专业知识和支持；并在适当的PHACS研究程序中训练和监视站点。 HSPH/CBAR，WESTAT和Frontier Science一起提供了长期的历史，提供了PHAC所需的方法和运营支持的类型，以及提高PHACS研究，行为设计和分析效率的创新方法。鉴于他们的先前和当前的专业经验，PI希望将其独特地定位，以提供科学和流行病学的领导才能成功地进行PHAC。