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

儿科艾滋病毒/艾滋病队列研究 (PHACS)：数据和运营中心 (DOC)。

• 批准号: 9757832
• 负责人: PAIGE L WILLIAMS
• 金额: $ 1879.26万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9757832
• 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; Clinical; Cognition; Cognitive; Cohort Studies; Communities; Consequences of HIV; Data; Data Collection; Data Set; Databases; Development; 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; Participant; Patients; Pediatric HIV/AIDS Cohort Study; Perinatal; Perinatal Exposure; Perinatal Infection; Population; Positioning Attribute; Prevention; Preventive; Principal Investigator; Procedures; Protocols documentation; Public Health; Public Health Schools; Quality Control; Recording of previous events; Research; Research Design; Research Methodology; Research Personnel; Risk; Safety; Science; 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; perinatal HIV; perinatal period; preadolescence; prenatal exposure; prevention service; public health relevance; quality assurance; recruit; research study; success; treatment services; 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) 于 2005 年创建，旨在评估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PHACS 由一个科学领导小组 (SLG) 组成，由协调中心、数据和中心负责监督。哈佛大学公共卫生学院流行病学系和艾滋病研究生物统计中心、Westat 和前沿科学基金会与 PHACS DOC 合作。 SLG 定义 PHACS 研究议程；为所有 PHACS 分析项目的开发提供方法领导；按照 PHACS 研究计划的适当程序维护 CU 分包合同并培训和监控站点；举办所有领导会议和完整的 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 (AMP)，该委员会由 450 名围产期艾滋病毒感染者组成。招募时年龄为 7-16 岁的受感染青少年和青春期前青少年，旨在调查艾滋病毒和抗逆转录病毒治疗对器官系统、生长和发育、性成熟、青春期发育、认知、情感发育、 AMP Up 随后旨在使用简化的、适合移动设备的药物毒性监测系统，对 AMP 参与者和其他年满 18 岁的 HIV 感染者进行追踪。逆转录病毒毒性 (SMART) 招募了 3,506 名围产期暴露于 HIV 的未感染儿童，以评估宫内 ART 暴露的长期影响。 DOC 将继续以越来越高效的方式执行 PHACS 科学议程，将另外 1,000 名新生儿纳入 SMARTT，并另外招募 525 名 HIV 感染者和暴露于 HIV 的未感染年轻人参加 AMP Up Together、HSPH、Westat。和前沿科学带来了提供 PHACS 所需的科学和运营领导力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，可以继续提供对 PHACS 持续成功至关重要的科学/流行病学和运营领导力。

项目成果

Mental health functioning among children and adolescents with perinatal HIV infection and perinatal HIV exposure.

围产期艾滋病毒感染和围产期艾滋病毒暴露的儿童和青少年的心理健康功能。

• 发表时间: 2011-12
• 影响因子: 1.7
• 作者: Malee, Kathleen M;Tassiopoulos, Katherine;Huo, Yanling;Siberry, George;Williams, Paige L;Hazra, Rohan;Smith, Renee A;Allison, Susannah M;Garvie, Patricia A;Kammerer, Betsy;Kapetanovic, Suad;Nichols, Sharon;Van Dyke, Russell;Seage 3rd, George
• 通讯作者: Seage 3rd, George

Point-of-care capillary blood lactate measurements in human immunodeficiency virus-uninfected children with in utero exposure to human immunodeficiency virus and antiretroviral medications.

对子宫内暴露于人类免疫缺陷病毒和抗逆转录病毒药物的未感染人类免疫缺陷病毒的儿童进行护理点毛细血管血乳酸测量。

• 发表时间: 2011-12
• 作者: Crain, Marilyn J;Williams, Paige L;Griner, Ray;Tassiopoulos, Katherine;Read, Jennifer S;Mofenson, Lynne M;Rich, Kenneth C;Pediatric HIVAIDS Cohort Study
• 通讯作者: Pediatric HIVAIDS Cohort Study

Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants.

暴露于人类免疫缺陷病毒的未感染婴儿的先天性异常和子宫内抗逆转录病毒暴露。

• 发表时间: 2015-01
• 影响因子: 26.1
• 作者: Williams, Paige L;Crain, Marilyn J;Yildirim, Cenk;Hazra, Rohan;Van Dyke, Russell B;Rich, Kenneth;Read, Jennifer S;Stuard, Emma;Rathore, Mobeen;Mendez, Hermann A;Watts, D Heather;Pediatric HIV/AIDS Cohort Study
• 通讯作者: Pediatric HIV/AIDS Cohort Study

Development and validation of the first liquid chromatography-tandem mass spectrometry assay for simultaneous quantification of multiple antiretrovirals in meconium.

开发和验证第一个液相色谱-串联质谱测定法，用于同时定量胎便中的多种抗逆转录病毒药物。

• 发表时间: 2013-02-05
• 影响因子: 7.4
• 作者: Himes, Sarah K;Scheidweiler, Karl B;Tassiopoulos, Katherine;Kacanek, Deborah;Hazra, Rohan;Rich, Kenneth;Huestis, Marilyn A;Pediatric HIV/AIDS Cohort Study
• 通讯作者: Pediatric HIV/AIDS Cohort Study

Safety of in utero and neonatal antiretroviral exposure: cognitive and academic outcomes in HIV-exposed, uninfected children 5-13 years of age.

子宫内和新生儿抗逆转录病毒暴露的安全性：5-13 岁未感染 HIV 儿童的认知和学业结果。

• 发表时间: 2014-11
• 作者: Nozyce, Molly L;Huo, Yanling;Williams, Paige L;Kapetanovic, Suad;Hazra, Rohan;Nichols, Sharon;Hunter, Scott;Smith, Renee;Seage 3rd, George R;Sirois, Patricia A;Pediatric HIVAIDS Cohort Study
• 通讯作者: Pediatric HIVAIDS Cohort Study