MTN-043/B-PROTECTED – A Phase IIIb open-label study that will evaluate the safety and acceptability of the monthly dapivirine ring, which is under regulatory review, and Truvada as daily PrEP in women who are breastfeeding, a time of heightened vulnerability for acquiring HIV. The study will enroll up to 200 breastfeeding mothers and their 6- to 12-week-old babies. Women will use their assigned product – PrEP or the dapivirine ring – for three months and be followed for an additional two weeks. Researchers will assess how much drug from Truvada and the dapivirine ring passes into breastmilk and how much passes to the baby after breastfeeding, and will measure the effects, if any, this may have on their health. B-PROTECTED will be conducted at the same sites as the DELIVER study, which are in Malawi, South Africa, Uganda and Zimbabwe.
Questions and Answers - The DELIVER and B-PROTECTED Studies