Global WACh

October 18, 2019

Dr. Jillian Pintye awarded grant to evaluate safety of infant PrEP exposure for long-term health outcomes

Dr. Jillian Pintye (Assistant Professor, School of Nursing) received a National Institutes for Health R01 award to lead a new study titled, “Evaluating Infant PrEP Exposure During Pregnancy and Breastfeeding.”

As the title suggests, Dr. Pintye and collaborators from Global WACh, International Clinical Research Center, Kenyatta National Hospital, and the University of California, San Francisco, will measure levels of pre- and postnatal pre-exposure prophylaxis (PrEP) exposure and its impact on infant health outcomes.  There has not yet been a large-scale safety evaluation of prenatal PrEP use and long-term outcomes beyond 12 months—a feat this new study hopes to achieve.

The study leverages the existing infrastructure of the PrEP Implementation for Mothers in Antenatal Care (PrIMA) cluster randomized trial led by Drs. Grace John-Stewart and Jared Baeten.  PrIMA aims to determine the best model for PrEP delivery implementation and safety of PrEP use among over 4,500 pregnant and lactating women attending 20 maternal-child health clinics in Western Kenya.  PrEP, when taken daily as recommended, is effective in preventing HIV acquisition for women in high-burden settings.  PrIMA recently demonstrated no significant difference in birth outcomes among PrEP-exposed and unexposed infants in the cohort.  Under Dr. Pintye and her team’s study, those infants will be part of a continued comprehensive safety evaluation up to five years of life in the largest PrEP in pregnancy evaluation to date.

The study aims will provide important new data by systematically quantifying infant PrEP exposure and assessing birth, bone, growth, and neurocognitive outcomes following PrEP exposure through the child’s fifth birthday.  This work will serve as an exemplar for future safety evaluations of novel PrEP agents in pregnant and lactating women.

Dr. Pintye was recently named the Washington Global Health Alliance’s 2019 Global Health Pioneers Rising Leader for her groundbreaking research on PrEP use during pregnancy.  We are thrilled for Dr. Pintye new research endeavors and look forward to sharing future progress.