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.

Project Narrative PHACS 2020 is 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) Surveillance Monitoring for ART Toxicities (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 Perinatal HIV (PHIV) (HPV); and 4; the TERBO BRAIN Study: Trajectories of Emotional Regulation and Behavior Outcomes and related Brain Regions And Intrinsic Networks (TERBO BRAIN). This multidisciplinary, interactive and synergistic P01 will address the most critical scientific questions for children, youth and young adults living with or exposed to perinatal HIV.