Pediatric HIV/AIDS Cohort Study (PHACS) Data and Operations Center (DOC): Understanding Maternal HIV Disease through Pregnancy and the Postpartum Period and its Role in Child Health Outcomes

儿科艾滋病毒/艾滋病队列研究 (PHACS) 数据和运营中心 (DOC)：了解孕期和产后期间的孕产妇艾滋病毒疾病及其在儿童健康结果中的作用

• 批准号: 9540260
• 负责人: George R Seage
• 金额: $ 183.86万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-08 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9540260
• 关键词: 15 year old; 18 year old; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adolescent; Adolescent and Young Adult; Affect; Age; Agreement; Anti-Retroviral Agents; Biometry; Caring; Child; Child health care; Clinical; Cognition; Cognitive; Cohort Studies; Communities; Consequences of HIV; Data; Data Collection; Data Set; Databases; Development; Disease; Drug toxicity; Educational Materials; Emotional; Enrollment; Ensure; Epidemiologist; Epidemiology; Exposure to; Family; Foundations; Growth and Development function; HIV; HIV Infections; HIV antiretroviral; HIV-infected adolescents; Health; Health Communication; Health Professional; Health education; Individual; Infant; Infection; Leadership; Logistics; Long-Term Effects; Longitudinal Studies; Manuals; Mentorship; Methodology; Methods; Monitor; National Institute of Child Health and Human Development; Newborn Infant; Outcome; Participant; Patients; Pediatric HIV/AIDS Cohort Study; Perinatal; Perinatal Infection; Population; Positioning Attribute; Postpartum Period; Pregnancy; Prevention; Preventive; Principal Investigator; Procedures; Protocols documentation; Public Health; Public Health Schools; Quality Control; Recording of previous events; Recruitment Activity; Research; Research Design; Research Methodology; Research Personnel; Risk; Role; Safety; Science; Services; Sexual Maturation; Site; Social Functioning; Socialization; Study Subject; Supervision; System; Technology; Toxic effect; Training; Translating; United States; Youth; aged; base; body system; chemotherapy; cohort; comparison group; cost; data management; data sharing; design; experience; follow-up; frontier; improved; in utero; innovation; instrument; leadership development; meetings; member; neonatal exposure; operation; pediatric human immunodeficiency virus; performance site; prenatal exposure; public health relevance; quality assurance; research study; success; working group; young adult

 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.

 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。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22个临床单位(CU)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研究中的生物统计中心，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，并按照适当的PHACS研究程序培训和监测地点；计划和举行所有领导和全面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；并支持积极的社区咨询委员会。青少年主方案(AMP)是由450名7-16岁的围产期感染艾滋病毒的青少年和青春期前青少年组成的队列，旨在调查艾滋病毒和抗逆转录病毒治疗对器官系统、生长发育、性成熟、青春期发育、认知、情感发展和社交的影响；AMP UP随后被设计用于延长AMP参与者和其他感染艾滋病毒的年轻人的随访，他们使用一种简化的、移动友好的方案。药物毒性监测系统抗逆转录病毒毒性监测(SMART)招募了3506名围产期接触艾滋病毒的未感染儿童，以评估宫内ART暴露的长期影响。在PHACS III中，DOC将继续以更有效率的方式执行PHACS的科学议程，将另外1000名新生儿加入SMARTT并对其进行跟踪，将另外525名感染艾滋病毒和暴露于HIV的未感染的年轻人加入AMP UP。HSPH、Westat和Frontier Science共同带来了提供PHACS所需的科学和操作领导的悠久而成功的历史，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。鉴于我们以前的经验，我们处于独特的地位，可以继续提供对PHACS的持续成功至关重要的科学/流行病学和业务领导。