Evaluating the safety of HIV prevention medication for infants during pregnancy and breastfeeding

Evaluating Infant PrEP Exposure During Pregnancy and Breastfeeding

NIH-funded research University of Washington · NIH-10654810

This study is looking at how safe it is for pregnant and new moms in Kenya to take a medication called PrEP to prevent HIV, and how it might affect their babies' growth and development during the first five years of life.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Washington NIH-funded
Lab location1 site (Seattle, United States)
Project IDNIH-10654810 on NIH RePORTER

What this research studies

This research investigates the safety of pre-exposure prophylaxis (PrEP) for HIV-negative pregnant and postpartum women in high HIV prevalence areas, particularly in Kenya. It aims to assess the exposure of infants to PrEP both in utero and through breastfeeding, and to evaluate the potential impacts on their growth, bone development, and neurocognitive outcomes up to the age of five. By analyzing hair samples from mother-infant pairs, the study will provide valuable data on the long-term effects of PrEP on infants. The research leverages an existing study infrastructure to extend follow-up and gather comprehensive safety profiles.

Who could benefit from this research

Good fit: Ideal candidates for this research are HIV-negative pregnant or postpartum women living in high HIV prevalence regions, particularly in Kenya.

Not a fit: Patients who are HIV-positive or those not pregnant or postpartum may not receive any benefit from this research.

Why it matters

Potential benefit: If successful, this research could provide critical insights into the safety of PrEP for infants, potentially leading to improved guidelines for HIV prevention in pregnant women.

How similar studies have performed: While there have been studies on PrEP, this research is unique as it focuses on long-term safety evaluations in infants, making it a novel approach.

Where this research is happening

Seattle, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.