Pediatric HIV/AIDS Cohort Study (PHACS) 2020

儿科艾滋病毒/艾滋病队列研究 (PHACS) 2020

• 批准号: 10663894
• 负责人: Ellen Gould Chadwick
• 金额: $ 1715.08万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-18 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663894
• 关键词: 13 year old; Address; Adolescent; Adolescent and Young Adult; Adult; Age; Aging; Anti-Retroviral Agents; Behavior; Brain; Brain region; Caring; Centers for Disease Control and Prevention (U.S.); Cervical Intraepithelial Neoplasia; Child; Child Health; Cognitive; Cohort Studies; Communities; Data Analyses; Development; Disease; Disease remission; Effectiveness; Epidemiologic Methods; Epidemiology; Exposure to; Grant; Growth; Guidelines; HIV; HIV Infections; HPV-High Risk; Health; Health education; Human Papillomavirus; Human papilloma virus infection; Individual; Infant; Infant Health; Infection; Infrastructure; Life Cycle Stages; Long-Term Effects; Monitor; Natural History; Neurologic; Oral health; Outcome; Pediatric HIV/AIDS Cohort Study; Perinatal; Persons; Pharmaceutical Preparations; Population; Pregnant Women; Prevalence; Prevention; Program Research Project Grants; Prospective, cohort study; Protocols documentation; Research Project Grants; Risk; Risk Factors; Safety; Series; Site; Statistical Methods; Testing; Toxic effect; Vaccinated; Youth; adverse birth outcomes; behavioral outcome; cardiometabolism; clinical research site; cohort; data management; data resource; design; emotion regulation; emotional behavior; experience; in utero; multidisciplinary; neurodevelopment; oral HPV; perinatal HIV; postnatal; programs; reproductive; social factors; structural determinants; success; transmission process; treatment response; young adult; young man; young woman

Project Summary/Abstract Each year, there are more than 1 million pregnant women living with HIV (PWLHIV) who receive antiretroviral medications (ARVs) for treatment and perinatal and postnatal HIV transmission prevention, with new ARVs introduced at a rapid pace. Although maternal use of ARVs has successfully reduced perinatal HIV transmission, there remains a clear need to monitor the safety of in utero ARV for infant and child health. Currently, 1.7 million children under the age of 15 are living with HIV globally – the vast majority with perinatally acquired HIV infection (PHIV) - who are aging into young adulthood. In the US, the Centers for Disease Control and Prevention (CDC) estimates that in 2016, there were 11,915 persons with PHIV in the U.S, including 1,814 children younger than 13 years of age and 10,101 adolescents and young adults. The lifelong impact of HIV and ARVs on their overall health is unknown as they transition into adulthood and adult HIV care. The Pediatric HIV/AIDS Cohort Study (PHACS) is a network, initiated in 2007, currently consisting of two prospective cohort studies: The Surveillance Monitoring for ART Toxicities Study (SMARTT), with over 4,000 infants, children and youth with perinatal HIV exposure but who are uninfected (PHEU), and the series of Adolescent Master Protocols (AMP, AMP Up and AMP Up Lite) studies following 1,000 young adults with perinatal HIV, and a comparison cohort of young adults with PHEU. These studies are designed to answer questions regarding the short and long term outcomes of HIV infection and ARV exposure or treatment. PHACS 2020 is designed as a Program Project P01 grant, consisting of the following four support Cores: Scientific Administrative Core (SAC), Data Resources Core (DRC), Health Education and Community Core (HECC), and the Epidemiological and Statistical Methods Core (ESC) to provide scientific, site and cohort infrastructure, data management and analysis, health education and community input, as well as epidemiological and statistical support to four Research Projects: 1) SMARTT; 2) The Adolescent Master Protocol (AMP) Up Series (the AMP Up Series); 3) Natural History of Cervical Intraepithelial Neoplasia (CIN) and Human Papillomavirus (HPV) in HPV Vaccinated Youth with PHIV (HPV); and the TERBO BRAIN Study: Trajectories of Emotional Regulation and Behavior Outcomes and related Brain Regions And Intrinsic Networks (TERBO BRAIN). This multidisciplinary, interdisciplinary, transdisciplinary and synergistic P01 will address the most critical scientific questions for children, youth and young adults exposed to or living with HIV.

项目概要/摘要 每年，有超过 100 万感染艾滋病毒 (PWLHIV) 的孕妇接受抗逆转录病毒治疗 用于治疗和预防围产期和产后艾滋病毒传播的药物（抗逆转录病毒药物），包括新的抗逆转录病毒药物 快速推出。尽管孕产妇使用抗逆转录病毒药物已成功减少围产期艾滋病毒 传播，显然仍然需要监测宫内抗逆转录病毒药物对婴儿和儿童健康的安全性。 目前，全球有 170 万 15 岁以下儿童感染艾滋病毒，其中绝大多数是围产期感染者 获得性艾滋病毒感染 (PHIV) - 即将进入成年早期的人。在美国，疾病控制中心 美国疾病预防控制中心 (CDC) 估计，2016 年，美国有 11,915 名 PHIV 感染者，其中 1,814 名 13 岁以下儿童以及 10,101 名青少年和年轻人。艾滋病毒的终生影响 当他们过渡到成年期和成人艾滋病毒护理时，抗逆转录病毒药物对他们整体健康的影响尚不清楚。 儿科艾滋病毒/艾滋病队列研究 (PHACS) 是一个网络，于 2007 年启动，目前由两个 前瞻性队列研究：ART 毒性监测研究 (SMARTT)，超过 4,000 名围产期接触过艾滋病毒但未感染的婴儿、儿童和青少年 (PHEU)，以及一系列 青少年大师方案（AMP、AMP Up 和 AMP Up Lite）对 1,000 名青少年进行了研究 围产期 HIV 和患有 PHEU 的年轻人的比较队列。这些研究旨在回答 关于艾滋病毒感染和抗逆转录病毒暴露或治疗的短期和长期结果的问题。 PHACS 2020 被设计为计划项目 P01 赠款，由以下四个支持核心组成： 科学管理核心（SAC）、数据资源核心（DRC）、健康教育和社区核心 (HECC) 和流行病学和统计方法核心 (ESC) 提供科学、现场和队列 基础设施、数据管理和分析、健康教育和社区投入，以及 为四个研究项目提供流行病学和统计支持：1) SMARTT； 2) 青春期大师 协议（AMP）Up 系列（AMP Up 系列）； 3) 宫颈上皮内瘤变的自然史 接种 HPV 疫苗的青少年感染 PHIV (HPV) 中的 (CIN) 和人乳头瘤病毒 (HPV)；和 TERBO 大脑研究：情绪调节和行为结果的轨迹及相关大脑区域 和内在网络（TERBO BRAIN）。这个多学科、跨学科、跨学科和 协同 P01 将解决儿童、青少年和年轻人面临的最关键的科学问题 感染艾滋病毒或感染艾滋病毒。