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.
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.
|Williams, Paige L; Crain, Marilyn J; Yildirim, Cenk et al. (2015) Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants. JAMA Pediatr 169:48-55|
|Siberry, George K; Patel, Kunjal; Pinto, Jorge A et al. (2014) Elevated aspartate aminotransferase-to-platelet ratio index in perinatally HIV-infected children in the United States. Pediatr Infect Dis J 33:855-7|
|Garvie, Patricia A; Zeldow, Bret; Malee, Kathleen et al. (2014) Discordance of cognitive and academic achievement outcomes in youth with perinatal HIV exposure. Pediatr Infect Dis J 33:e232-8|
|Patel, Kunjal; Wang, Jiajia; Jacobson, Denise L et al. (2014) Aggregate risk of cardiovascular disease among adolescents perinatally infected with the human immunodeficiency virus. Circulation 129:1204-12|
|Nozyce, Molly L; Huo, Yanling; Williams, Paige L et al. (2014) Safety of in utero and neonatal antiretroviral exposure: cognitive and academic outcomes in HIV-exposed, uninfected children 5-13 years of age. Pediatr Infect Dis J 33:1128-33|
|Alperen, Julie; Brummel, Sean; Tassiopoulos, Katherine et al. (2014) Prevalence of and risk factors for substance use among perinatally human immunodeficiency virus-infected and perinatally exposed but uninfected youth. J Adolesc Health 54:341-9|
|Persaud, Deborah; Patel, Kunjal; Karalius, Brad et al. (2014) Influence of age at virologic control on peripheral blood human immunodeficiency virus reservoir size and serostatus in perinatally infected adolescents. JAMA Pediatr 168:1138-46|
|Kapetanovic, Suad; Griner, Ray; Zeldow, Bret et al. (2014) Biomarkers and neurodevelopment in perinatally HIV-infected or exposed youth: a structural equation model analysis. AIDS 28:355-64|
|Lipshultz, Steven E; Chandar, Jayanthi J; Rusconi, Paolo G et al. (2014) Issues in solid-organ transplantation in children: translational research from bench to bedside. Clinics (Sao Paulo) 69 Suppl 1:55-72|
|Usitalo, Ann; Leister, Erin; Tassiopoulos, Katherine et al. (2014) Relationship between viral load and self-report measures of medication adherence among youth with perinatal HIV infection. AIDS Care 26:107-15|
Showing the most recent 10 out of 58 publications