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.

Public Health Relevance

The activities described in this proposal will provide public health professionals and patients with an increased understanding of the risk and/or safety of antiretroviral use in the perinatal period and the affects of HIV on the development of youth, adolescents, and young adults. This increased understanding can subsequently translate into improved prevention and treatment services for individuals and families affected by HIV/AIDS.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HD052102-12S2
Application #
9336064
Study Section
Program Officer
Russo, Denise
Project Start
2016-08-23
Project End
2017-06-30
Budget Start
2016-09-07
Budget End
2017-06-30
Support Year
12
Fiscal Year
2016
Total Cost
$200,000
Indirect Cost
$66,667
Name
Harvard University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02115
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Rough, Kathryn; Seage 3rd, George R; Williams, Paige L et al. (2018) Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine. N Engl J Med 378:1593-1603
Bansal, Neha; Barach, Paul; Amdani, Shahnawaz M et al. (2018) When is early septal myectomy in children with hypertrophic cardiomyopathy justified? Transl Pediatr 7:362-366
Goodenough, Christopher J; Patel, Kunjal; Van Dyke, Russell B et al. (2018) Is There a Higher Risk of Mother-to-child Transmission of HIV Among Pregnant Women With Perinatal HIV Infection? Pediatr Infect Dis J 37:1267-1270
Jao, J; Yu, W; Patel, K et al. (2018) Improvement in lipids after switch to boosted atazanavir or darunavir in children/adolescents with perinatally acquired HIV on older protease inhibitors: results from the Pediatric HIV/AIDS Cohort Study. HIV Med 19:175-183
Shiboski, Caroline H; Yao, Tzy-Jyun; Russell, Jonathan S et al. (2018) The association between oral disease and type of antiretroviral therapy among perinatally HIV-infected youth. AIDS 32:2497-2505
Harris, Lynnette L; Chernoff, Miriam C; Nichols, Sharon L et al. (2018) Prospective memory in youth with perinatally-acquired HIV infection. Child Neuropsychol 24:938-958
Lipshultz, Steven E (2018) Letter by Lipshultz Regarding Article, ""Anthracycline Cardiotoxicity: Worrisome Enough to Have You Quaking?"" Circ Res 122:e62-e63
Alperen, Julie; Davidson, Julie; Siminski, Suzanne et al. (2018) Utility of the National Death Index in Identifying Deaths in a Clinic-Based, Multisite Cohort: The Experience of the Pediatric HIV/AIDS Cohort Study. J Acquir Immune Defic Syndr 79:e37-e39
Garvie, Patricia A; Nichols, Sharon L; Williams, Paige L et al. (2018) Development and reliability of the Prospective Memory Assessment for Children & Youth (PROMACY): A preliminary study in a nonclinical sample. Appl Neuropsychol Child :1-14

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