Pregnancy safety and infant outcomes with long-acting PrEP agents (CAB-LA and LEN) for HIV prevention
Official title: Expanding a Prospective Pregnancy Cohort to Evaluate Safety and Infant Outcomes of Long-Acting PrEP Agents, Including Lenacapavir.
Funded at Univ of North Carolina Chapel Hill · NIH-11468380 · Data updated 2026-11-12
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.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Univ of North Carolina Chapel Hill NIH-funded |
| Lab location | 1 site (Chapel Hill, United States) |
| Project start | September 3, 2026 |
| Project end | August 31, 2031 |
| Funding year | 2026 |
| Award (this year) | $573,997 |
| NIH project number | 1R01HD123811-01 |
| Project ID | NIH-11468380 on NIH RePORTER |
Who could benefit from this research
✓Could help
Pregnant or breastfeeding women who are using or starting long-acting PrEP agents (CAB-LA or LEN) or oral PrEP.
✕Less likely to help
Women not considering PrEP or not pregnant/breastfeeding are unlikely to benefit from this study.
What this research studies
Researchers will expand an ongoing pregnancy safety cohort to include women starting or continuing lenacapavir (LEN) as it becomes available, comparing safety outcomes across oral PrEP, cabotegravir long-acting PrEP (CAB-LA), and LEN. They will track composite adverse pregnancy outcomes, higher-grade maternal and infant adverse events up to one year postpartum, and infant growth and neurodevelopment by PrEP exposure. The goal is to generate real-world safety data to guide recommendations for PrEP use during pregnancy and breastfeeding. This is built on a real-world setting with diverse populations and aims to inform clinical practice and patient counseling.
Why it matters
Potential benefit: If successful, the study could provide critical safety information to help clinicians and pregnant/breastfeeding patients choose among PrEP options with better understanding of risks and benefits.
How similar studies have gone: Previous cohorts have provided real-world safety data for oral PrEP and CAB-LA; LEN safety in pregnancy is being explored in this expanding cohort.
Where this research is happening
-
Univ of North Carolina Chapel Hill
Chapel Hill, United States Active
Researchers
- Principal investigator: Hosseinipour, Mina Christine — Univ of North Carolina Chapel Hill
- Study coordinator: Hosseinipour, Mina Christine
Related research
Other NIH-funded projects on the same topics.
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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.
-
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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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.
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PrEP in Pregnancy and Postpartum Data Hub
A patient-friendly data-sharing project that brings together information from many pregnancy and postpartum PrEP studies to better understand HIV prevention for mothers and their babies.
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Adapted problem-solving program to boost PrEP use in pregnant women in Zimbabwe
A multi-level program is being adapted to help pregnant and postpartum women in Zimbabwe start and stick with PrEP to prevent HIV.
-
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.
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.