Better HIV prevention pills for pregnant women in sub‑Saharan Africa
Official title: Optimizing PrEP regimens for pregnant women in sub-Saharan Africa
Funded at Univ of North Carolina Chapel Hill · NIH-11322082 · Data updated 2026-11-12
Compares standard and higher daily PrEP pill doses to find the safest, most protective option for pregnant women in sub‑Saharan Africa.
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 | April 13, 2021 |
| Project end | March 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $297,779 |
| NIH project number | 5R01AI157859-06 |
| Project ID | NIH-11322082 on NIH RePORTER |
Who could benefit from this research
✓Could help
HIV‑negative pregnant women about 14–24 weeks gestation living in sub‑Saharan Africa and eligible for daily oral FTC/TDF PrEP.
✕Less likely to help
People who are not pregnant, who already have HIV, or who cannot take FTC/TDF for medical reasons (for example, severe kidney disease or drug allergy) would not benefit from participating.
What this research studies
You would be randomly assigned to take one of three daily PrEP doses (standard dose, 150% of standard, or 200% of standard) during pregnancy. Each participant completes two 14‑day dosing cycles in the second and third trimesters with intensive 24‑hour blood sampling to measure drug levels, and then takes the standard dose at 12 weeks postpartum for comparison. The team compares drug concentrations in blood cells between pregnancy and postpartum and monitors safety during and after pregnancy. This helps researchers identify a dose that keeps protective drug levels during pregnancy while tracking possible side effects for mother and baby.
Why it matters
Potential benefit: Could identify a PrEP dose that maintains protective drug levels in pregnancy and reduce HIV infections in mothers and their infants.
How similar studies have gone: Standard daily FTC/TDF PrEP reduces HIV risk overall but produces lower drug levels during pregnancy, and higher-dose PrEP in pregnancy has limited prior safety data.
Where this research is happening
-
Univ of North Carolina Chapel Hill
Chapel Hill, United States Active
Researchers
- Principal investigator: Chi, Benjamin H. — Univ of North Carolina Chapel Hill
- Study coordinator: Chi, Benjamin H.
Related research
Other NIH-funded projects on the same topics.
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Safer PrEP dosing for pregnant women in sub‑Saharan Africa
Seeing if higher daily doses of the HIV prevention pill FTC/TDF during pregnancy help women in sub‑Saharan Africa maintain stronger protection from HIV.
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Improving PrEP outcomes for pregnant women in Botswana with integrated STI testing and PrEP delivery
A study in Botswana aims to help pregnant and postpartum women use HIV prevention methods more effectively by mixing STI testing with choices like oral PrEP and the dapivirine vaginal ring.
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HIV prevention for pregnant and postpartum women in Botswana using STI testing and PrEP options
This project offers STI testing plus two HIV prevention choices—daily oral PrEP pills and a dapivirine vaginal ring—to help pregnant and postpartum women in Botswana avoid HIV.
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Finding the best PrEP doses for pregnant women in sub-Saharan Africa
This study is looking at the best way to give HIV prevention medication to pregnant women in sub-Saharan Africa to help keep them safe from HIV, and it will involve trying different doses during their pregnancy and checking how well it works and how safe it is afterward.
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Improving HIV prevention for pregnant women in Botswana
This study is looking at ways to help pregnant women in Botswana use HIV prevention methods more easily, by combining STI testing with PrEP services during their check-ups, so they can stay healthy and protect their babies.
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mChoice: Boosting PrEP Use and Adherence for Black and Latino MSM with Tailored Training and Support
A national study to help Black and Latino men who have sex with men start and stick with PrEP through culturally matched provider training and patient support.
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.