Preventing infant HIV infections in Malawi

Preventing Infant Infections with Implementation Science in Malawi

['FUNDING_P01'] · UNIV OF NORTH CAROLINA CHAPEL HILL · NIH-11325791

This program will try new ways to stop mothers from getting HIV during pregnancy and breastfeeding and to keep pregnant and breastfeeding women with HIV linked to care in Malawi.

Quick facts

Phase['FUNDING_P01']
Study typeNih_funding
SexAll
SponsorUNIV OF NORTH CAROLINA CHAPEL HILL (nih funded)
Locations1 site (CHAPEL HILL, UNITED STATES)
Trial IDNIH-11325791 on ClinicalTrials.gov

What this research studies

You could be invited to join one of three clinical projects aimed at stopping mothers from acquiring HIV and protecting their babies. One project will track people who use oral or injectable PrEP during pregnancy and breastfeeding, including a national registry and a safety cohort. Other projects focus on finding and re-engaging pregnant and postpartum women with HIV who have been missed by routine care, using implementation strategies and data-driven approaches. Local clinics, an implementation science team, and a data core will work together to deliver and monitor these efforts.

Who could benefit from this research

Good fit: Pregnant or breastfeeding women in Malawi who are HIV-negative and considering or using PrEP, or women living with HIV during pregnancy/postpartum who may have missed or disengaged from care, are the primary candidates.

Not a fit: People who are not pregnant or breastfeeding, those living outside Malawi, or those not receiving care at participating clinics are unlikely to be eligible or benefit directly.

Why it matters

Potential benefit: If successful, the program could lower new maternal HIV infections and reduce the number of infants born with HIV by improving prevention and care during pregnancy and breastfeeding.

How similar studies have performed: Daily oral TDF/FTC PrEP has helped prevent HIV in other groups, while long-acting injectable cabotegravir is promising but has limited safety data in pregnancy, so this program addresses an important evidence gap.

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.

View on NIH RePORTER →

Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus

Last reviewed 2026-05-15 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.