|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 32 clinical sites at 21 institutions, 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 three 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 three 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 3,000 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.
These 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