Protecting mothers and babies from HIV during pregnancy and breastfeeding in Malawi

Project 1 - Surveillance and monitoring systems to identify strategies to improve perinatal practices [Parent Title: PREVENTING INFANT INFECTIONS WITH IMPLEMENTATION SCIENCE IN MALAWI]

NIH-funded research Univ of North Carolina Chapel Hill · NIH-11325803

This project tests whether daily oral PrEP or a long‑acting injectable PrEP can help pregnant and breastfeeding women in Malawi stay HIV‑free.

Quick facts

Grant typeP01 program project
Study typeNIH-funded research
Funding institutionUniv of North Carolina Chapel Hill NIH-funded
Lab location1 site (Chapel Hill, United States)
Project IDNIH-11325803 on NIH RePORTER

What this research studies

If you are an HIV‑negative pregnant or breastfeeding woman at risk of HIV, this project offers HIV prevention through routine antenatal clinic services and close monitoring. Women may be offered daily oral tenofovir/emtricitabine (TDF/FTC) or the newer long‑acting injectable cabotegravir, with regular follow‑up to track adherence, safety, and pregnancy outcomes. The team builds surveillance and monitoring systems at clinics to spot gaps in care and improve perinatal practices that protect mothers and infants. Data from pregnancies that occur while on PrEP will be collected to better understand safety for mothers and babies.

Who could benefit from this research

Good fit: HIV‑negative pregnant or breastfeeding women receiving antenatal care at participating clinics in Malawi who are at risk of HIV exposure.

Not a fit: People who are living with HIV, not pregnant or breastfeeding, or not receiving care at participating clinics are unlikely to benefit directly from this project.

Why it matters

Potential benefit: Could give pregnant and breastfeeding women safer, easier ways to avoid HIV and lower the risk of passing HIV to their babies.

How similar studies have performed: Daily oral TDF/FTC has been shown to prevent HIV when taken consistently, and long‑acting cabotegravir has prevented HIV in other populations but has limited safety data in pregnancy.

Where this research is happening

Chapel Hill, United States

Researchers

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 below.
Conditions Acquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome Virus
Last reviewed 2026-06-10 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.