Better HIV prevention pills for pregnant women in sub‑Saharan Africa
Optimizing PrEP regimens for pregnant women in sub-Saharan Africa
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 ID | NIH-11322082 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: HIV‑negative pregnant women about 14–24 weeks gestation living in sub‑Saharan Africa and eligible for daily oral FTC/TDF PrEP.
Not a fit: 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.
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 performed: 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
Chapel Hill, United States
- 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.
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 below.