||PHACS began in 2005 to address two critical pediatric HIV research questions: |
- What is the long-term safety of fetal and infant exposure to antiretroviral therapy (ART)?
- What are the effects of perinatally acquired HIV infection in adolescents
PHACS is funded by the NICHD Maternal and Pediatric Infectious Disease Branch (formerly the Pediatric, Adolescent, and Maternal AIDS Branch); the National Heart, Lung, and Blood Institute; the National Institute of Alcohol Abuse and Alcoholism; the National Institute of Allergy and Infectious Diseases; the National Institute on Deafness and Other Communication Disorders; the National Institute of Dental and Craniofacial Research; the National Institute on Drug Abuse; the National Institute of Mental Health; the National Institute of Neurological Disorders and Stroke; and the NIH Office of AIDS Research.
The PHACS Network is funded through Cooperative Agreement (U01) and currently comprises 21 clinical sites, a Data and Operations Center (DOC), and a Coordinating Center (CC). The DOC provides operations, design, methodological, and analytic expertise to PHACS research protocols, while the CC provides support and guidance to the PHACS Scientific Leadership Group, which helps to guide the network's scientific directions and ensure its scientific integrity. Additional oversight and coordination are provided by an executive committee and a steering committee. To maximize efficiency, the PHACS Network has data-sharing agreements with other studies and cross-enrolls participants with non-PHACS protocols.
The overall goals of this Network are to:
- Understand how HIV and its treatment affect growth and development, sexual maturation, organ function, and socialization of perinatally HIV-infected pre-adolescents, adolescents, and young adults;
- Acquire more definitive information on the long-term safety of ART when used during pregnancy and in newborns;
- Ensure a mechanism is in place to estimate the upper bounds of risk for children who were exposed to ART during maternal treatment to prevent perinatal HIV transmission; and
- Continue the follow-up study of these populations.
PHACS currently conducts two major studies (described below):
- Surveillance Monitoring for ART Toxicities Study in HIV-Uninfected Children Born to HIV-Infected Women (SMARTT)
- Adolescent Master Protocol (AMP).
Both SMARTT and AMP also include sub-studies focused on infant bone health, memory and attention, nutrition during pregnancy, mitochondrial research, neuroimaging, epigenetics, oral health, and pulmonary function.
PHACS conducts two major studies:
- SMARTT, which follows HIV-negative children exposed to ART in utero or in the first months of life:
- Examines the occurrence of abnormalities among these children in multiple domains.
- Includes more than 2,700 children who are under active follow-up.
- Enrolls an open cohort of approximately 300 newborns per year to allow for study of exposures to new combinations of ART.
- Includes a control group of approximately 200 HIV-uninfected children at 1, 3, 5, or 9 years of age born to HIV-uninfected mothers; the study used funds from the American Recovery and Reinvestment Act of 2010 to add this group.
- AMP, which is examining the impact of HIV infection and treatment on pre-adolescents and adolescents:
- Investigates several domains of health and development in HIV-infected and uninfected children born to HIV-infected mothers
- Includes approximately 700 children and adolescents between 7 and 15 years of age.
- Is now closed to new enrollment.
These two studies examine the following and other effects and risk factors related to HIV infection, antiretroviral use, and antiretroviral exposure in developing children and youth:
- Neurodevelopmental, cognitive, academic, vocational, behavioral, and social outcomes
- Impairment of hearing, language, and learning and other communication disorders
- Substance use and mental health outcomes
- Adherence to treatments and interventions
- Growth, endocrinology, and bone development
- Sexual maturation, gynecology, reproductive capacity, sexual health, and HIV-risk behaviors
- Nutrition, body composition, and tissue redistribution syndromes
- Cardiovascular complications and disease risk
- Genetics and epigenetics related to HIV infection, HIV treatment, and antiretroviral exposure
- Effects of maternal substance use on child outcomes
- Oral health
- Pulmonary complications
- Renal complications
- Baylor College of Medicine, Texas (SMARTT, AMP)
- Bronx Lebanon Hospital Center, New York (SMARTT, AMP)
- Children's Diagnostic and Treatment Center, Florida (SMARTT, AMP)
- Children's Hospital Boston, Massachusetts (AMP)
- Children's Memorial Hospital, Illinois (SMARTT, AMP)
- Jacobi Medical Center, New York (AMP)
- New York University School of Medicine, New York (SMARTT)
- St. Christopher's Hospital for Children, Pennsylvania (AMP)
- St. Jude Children's Research Hospital, Tennessee (SMARTT, AMP)
- San Juan Research Hospital, Puerto Rico (SMARTT, AMP)
- State University of New York (SUNY) Downstate Medical Center (SMARTT)
- Tulane University Health Sciences Center, Louisiana (SMARTT, AMP)
- University of Alabama (SMARTT)
- University of California, San Diego (SMARTT, AMP)
- University of Colorado, Denver Health Sciences Center (SMARTT, AMP)
- University of Florida Health Science Center (SMARTT)
- University of Illinois, Chicago (SMARTT)
- University of Medicine and Dentistry of New Jersey (SMARTT, AMP)
- University of Miami, Florida (SMARTT, AMP)
- University of Puerto Rico Medical Center (SMARTT)
- University of Southern California (SMARTT)
The Harvard School of Public Health serves as the PHACS DOC and the PHACS CC is at Tulane University.