MTN-043, or B-PROTECTED, is a Phase IIIb open-label study that evaluated the safety and acceptability of the monthly dapivirine ring, which is under regulatory review in several African countries, and Truvada as daily oral PrEP in women who are breastfeeding, a time of heightened vulnerability for acquiring HIV. The study enrolled 200 breastfeeding mothers and their 6- to 12-week-old babies at four sites in Malawi, South Africa, Uganda and Zimbabwe. Women used their assigned product – oral PrEP or the dapivirine ring – for three months and were followed for an additional two weeks. Researchers assessed how much drug from Truvada and the dapivirine ring passes into breastmilk and how much passes to the baby after breastfeeding, and measured the effects, if any, this may have had on their health. B-PROTECTED was began in September 2020 and completed all follow-up in November 2021. Results are anticipated mid-2022.
Questions and Answers - The DELIVER and B-PROTECTED Studies