NIH-funded research R01 grant

Safer PrEP dosing 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-11512886 · Data updated 2026-11-12

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.

More PrEP research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniv of North Carolina Chapel Hill
NIH-funded
Lab location1 site (Chapel Hill, United States)
Project startApril 1, 2026
Project endMarch 31, 2027
Funding year2026
Award (this year)$28,913
NIH project number3R01AI157859-06S1
Project IDNIH-11512886 on NIH RePORTER

Who could benefit from this research

Could help

Pregnant women in their second trimester (about 14–24 weeks), at risk for HIV, who can take daily oral PrEP and attend follow‑up visits are the ideal candidates.

Less likely to help

People who are already HIV‑positive, not pregnant, or unwilling/unable to take daily pills and complete follow‑up visits are unlikely to benefit from this project.

What this research studies

If I join, I would be randomly placed on one of three daily pill doses of FTC/TDF during pregnancy. I would take two 14‑day pill cycles in the second and third trimesters with detailed blood sampling over 24 hours to measure drug levels inside immune cells. At about 12 weeks after delivery I would take the standard dose again so researchers can compare pregnancy and postpartum drug levels. The team will also watch for any side effects for me and my baby.

Why it matters

Potential benefit: If successful, this work could lead to dosing guidelines that give pregnant women better protection against HIV during pregnancy and breastfeeding.

How similar studies have gone: Standard FTC/TDF PrEP is effective in nonpregnant people and prior work shows pregnancy lowers tenofovir levels, but testing higher doses specifically in pregnancy is a relatively new approach with limited direct clinical evidence.

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.

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.
Last reviewed 2026-11-14 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.