MTN-042/DELIVER is a Phase IIIb open-label study designed to evaluate the safety and acceptability of the monthly dapivirine vaginal ring, which is under regulatory review in several African countries, and Truvada as daily oral PrEP in pregnant women. Both DELIVER and its sister study, B-PROTECTED (MTN-043), aim to provide the kind of information national programs, health care providers and women themselves need to make informed decisions about the use of the ring or oral PrEP during pregnancy and breastfeeding when women are up to four times more likely to acquire HIV. DELIVER, which is being conducted at four trial sites in Malawi, South Africa, Uganda and Zimbabwe, is designed to be conducted in stepwise fashion, enrolling one group of women at a time, beginning with women late in pregnancy, with participants randomly assigned to use either the ring or oral PrEP until the time they deliver. Interim reviews of study data by an independent panel of experts is to take place after completion of each group and the study will proceed to enroll the next group only if deemed safe to do so.
DELIVER, which began in February 2020, completed follow-up of the first cohort of participants – 150 women who were 8-9 months pregnant when they enrolled. – in May 2021. Finding no safety concerns, the study proceeded to the second cohort, which in early March 2022 had completed enrolment with 157 women between 7-8 months pregnant. Provided there are no safety concerns, the last group of participants to be enrolled will be approximately 250 women who are 3-7 months pregnant. DELIVER is expected to be completed in early 2023.
Questions and Answers - The DELIVER and B-PROTECTED Studies
MTN-042 Study Page