The Surveillance Monitoring for ART Toxicities (SMARTT) Protocol evaluates the long-term safety of antiretroviral (ARV) medications taken during pregnancy among women living with HIV (WLHIV) and their children born without HIV. The PHACS SMARTT study is the largest study of pregnant WLHIV in the United States, and one of the only large studies in the world to follow children born to WLHIV beyond infancy.
A major focus of the SMARTT study is the evaluation of effects of maternal exposures to ARVs, prescribed medications, and substance use during pregnancy on health outcomes in their infants and children. These health outcomes cross a wide spectrum of domains including:
- Hearing and language
- Neurologic functioning
Although the primary focus of SMARTT is the evaluation of safety of in utero ARV exposures on children, the information we collect about mothers during pregnancy, postpartum, and beyond can also be used to study critical issues facing women living with HIV, including:
- Reproductive health
- Important pregnancy complications such as gestational diabetes, pre-eclampsia, anemia, and hypertensive disorders of pregnancy
- Postpartum mental health
- The role of other factors such as environmental exposures during pregnancy on post-pregnancy health outcomes
- HIV-related stigma and maternal disclosure
Findings from the SMARTT study have informed national and international treatment guidelines of WLHIV during pregnancy. The SMARTT study aims to enroll 200 mothers and their babies each year and will continue to follow child participants as follows:
- All children followed to age 5
- A smaller group of children followed to age 17
- Mothers and other enrolled caregivers are also followed along with their child to provide information on both their own health and their child’s health.