Advancing HIV prevention options: Women who are pregnant or breastfeeding

HIV risk is an estimated two to four times higher during pregnancy and postpartum periods, yet pregnant and breastfeeding women are underrepresented in HIV prevention research.

Results from a set of studies will help us better understand the ring's safety when used during these times and could inform potential expansion of the ring’s regulatory approval to these key groups, if granted:

  • IPM partnered with MTN on a now-completed safety study among women in the US who were lactating but no longer nursing (MTN-029/IPM 039), which found a favorable safety profile among women and estimated low dapivirine levels for infants.
  • The ongoing DELIVER study is assessing the safety and pharmacokinetics of the monthly ring and daily oral PrEP among women at different stages of pregnancy, helping to fill a research gap for both products. The open-label study will closely monitor participants to ensure the safety of the woman and fetus. DELIVER began in February 2020 in South Africa and will also take place in Malawi, Uganda and Zimbabwe, with results expected in 2024.
  • B-PROTECTED is an open-label study that began in August 2020 to assess the safety and pharmacokinetics of the monthly ring and daily oral PrEP among breastfeeding mothers and their infants in Malawi, South Africa, Uganda and Zimbabwe. Safety data for both products’ use among this group are currently limited.