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. A cohort of 450 perinatally infected adolescents and preadolescents (Adolescent Master Protocol, AMP, age 7-16 at enrollment) was established to evaluate the impact of HIV and ART on sexual maturation, pubertal development, and socialization;and, a drug toxicity surveillance system (Surveillance Monitoring for Anti-Retroviral Toxicities Study (SMARTT) enrolled 1,934 perinatally HIV exposed uninfected children to evaluate long-term effects of in-utero ART exposure. PHACS is comprised of a Scientific Leadership Group (SLG), which is overseen by a Coordinating Center, a Data and Operations Center (DOC), and 24 clinical sites. The Department of Epidemiology and the Center for Biostatistics in AIDS Research (CBAR) at the Harvard School of Public Health, Westat, and the Frontier Science Foundation collaborate to form the PHACS DOC. The DOC collaborates with the SLG to define the PHACS research agenda;provides methodological support for the development of all PHACS analytic projects;merges data from pre-existing databases from previous cohorts (PACTG 219/219C, WITS, Legacy);maintains clinical site subcontracts and trains and monitors sites in proper procedures for PHACS research;plans and conducts all leadership and full PHACS network meetings;and, supports an active CAB. In PHACS II, the DOC will continue the duties described above while refining its practices, as well as follow and enroll an additional 1,200-1,500 children into SMARTT. Together, HSPH, Westat and Frontier Science bring long histories of providing the type of methodologic and operational support required by PHACS, as well as innovative methods to enhance and maximize the efficiency of PHACS study design, conduct, and analysis. Given our prior and current professional experience, we are uniquely positioned to provide the scientific/epidemiologic and operational leadership to successfully conduct PHACS.

Public Health Relevance

The activities described in this application are relevant to public health in that they will provide public health professionals with an increased understanding of the risks of antiretroviral use in the prenatal period and the affects of HIV on the development of youth and adolescents. This increased understanding can subsequently translate into improved prevention and treatment services for 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 #
5U01HD052102-07
Application #
8137234
Study Section
Special Emphasis Panel (ZHD1-DSR-A (06))
Program Officer
Mofenson, Lynne M
Project Start
2005-09-30
Project End
2015-07-31
Budget Start
2011-08-01
Budget End
2012-07-31
Support Year
7
Fiscal Year
2011
Total Cost
$16,564,020
Indirect Cost
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
Fulcher, Isabel R; Tchetgen Tchetgen, Eric J; Williams, Paige L (2017) Mediation Analysis for Censored Survival Data Under an Accelerated Failure Time Model. Epidemiology 28:660-666
Garvie, Patricia A; Brummel, Sean S; Allison, Susannah M et al. (2017) Roles of Medication Responsibility, Executive and Adaptive Functioning in Adherence for Children and Adolescents With Perinatally Acquired HIV. Pediatr Infect Dis J 36:751-757
Shearer, William T; Jacobson, Denise L; Yu, Wendy et al. (2017) Long-term pulmonary complications in perinatally HIV-infected youth. J Allergy Clin Immunol 140:1101-1111.e7
Bellavia, Andrea; Williams, Paige L; DiMeglio, Linda A et al. (2017) Delay in sexual maturation in perinatally HIV-infected youths is mediated by poor growth. AIDS 31:1333-1341
Neilan, Anne M; Karalius, Brad; Patel, Kunjal et al. (2017) Association of Risk of Viremia, Immunosuppression, Serious Clinical Events, and Mortality With Increasing Age in Perinatally Human Immunodeficiency Virus-Infected Youth. JAMA Pediatr 171:450-460
Rice, Mabel L; Russell, Jonathan S; Frederick, Toni et al. (2017) Risk for Speech and Language Impairments in Pre-school Aged HIV-Exposed Uninfected Children with in utero Combination Antiretroviral Exposure. Pediatr Infect Dis J :
Lewis-de Los Angeles, C Paula; Williams, Paige L; Huo, Yanling et al. (2017) Lower total and regional grey matter brain volumes in youth with perinatally-acquired HIV infection: Associations with HIV disease severity, substance use, and cognition. Brain Behav Immun 62:100-109
Jao, Jennifer; Powis, Kathleen M; Kirmse, Brian et al. (2017) Lower mitochondrial DNA and altered mitochondrial fuel metabolism in HIV-exposed uninfected infants in Cameroon. AIDS 31:2475-2481
Jacobson, Denise L; Stephensen, Charles B; Miller, Tracie L et al. (2017) Associations of Low Vitamin D and Elevated Parathyroid Hormone Concentrations With Bone Mineral Density in Perinatally HIV-Infected Children. J Acquir Immune Defic Syndr 76:33-42
Ryder, Mark I; Yao, Tzy-Jyun; Russell, Jonathan S et al. (2017) Prevalence of periodontal diseases in a multicenter cohort of perinatally HIV-infected and HIV-exposed and uninfected youth. J Clin Periodontol 44:2-12

Showing the most recent 10 out of 125 publications