Evaluating the safety of HIV prevention medication for infants during pregnancy and breastfeeding
Official title: Evaluating Infant PrEP Exposure During Pregnancy and Breastfeeding
Funded at University of Washington · NIH-10654810 · Data updated 2026-11-12
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 type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Washington NIH-funded |
| Lab location | 1 site (Seattle, United States) |
| Project start | September 24, 2019 |
| Project end | June 30, 2025 |
| Funding year | 2023 |
| Award (this year) | $661,717 |
| NIH project number | 5R01HD100201-05 |
| Project ID | NIH-10654810 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are HIV-negative pregnant or postpartum women living in high HIV prevalence regions, particularly in Kenya.
✕Less likely to help
Patients who are HIV-positive or those not pregnant or postpartum may not receive any benefit from this research.
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.
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 gone: 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
-
University of Washington
Seattle, United States Active
Researchers
- Principal investigator: Pintye, Jillian — University of Washington
- Study coordinator: Pintye, Jillian
Related research
Other NIH-funded projects on the same topics.
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Using text messages to help pregnant women stay on HIV prevention medication
This study is looking to help pregnant and new moms in areas with high rates of HIV remember to take their prevention medication by sending them supportive text messages, making it easier for them to stay healthy.
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Healthy Families-PrEP: helping women in Uganda start and stay on PrEP during periconception, pregnancy, and postpartum
A program in Uganda helps periconception, pregnant, and postpartum women use PrEP safely to prevent HIV, with support sessions and monitoring.
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Adaptation of a problem-solving approach to boost PrEP use during pregnancy in Zimbabwe
A multi-level program is being adapted to help pregnant and postpartum women in Zimbabwe start and stick with HIV PrEP, with support from providers and communities.
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CAB-LA PrEP for breastfeeding women after delivery in Botswana
This study tests a long-acting HIV prevention shot for new mothers who are breastfeeding in Botswana to see if it prevents HIV safely and effectively.
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Healthy Families-PrEP: helping pregnant and new mothers in Uganda stay HIV-free
A family-focused program in Uganda tests an approach to help women who are planning pregnancy or are pregnant or postpartum use PrEP to prevent HIV infection.
-
Pregnancy safety and infant outcomes with long-acting PrEP agents (CAB-LA and LEN) for HIV prevention
This study follows pregnant and breastfeeding women using long-acting PrEP drugs to understand safety for moms and babies when these medicines are taken during pregnancy and after birth.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.