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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.

Study finds no safety concerns when the dapivirine vaginal ring is used during the second and third trimesters of pregnancy, according to results presented at CROI 2024

No safety concerns seen with use of dapivirine vaginal ring during third trimester of pregnancy, according to interim results of DELIVER study

Questions and Answers - The DELIVER and B-PROTECTED Studies

Where we are with the DELIVER and B-PROTECTED studies: 3 things you need to know (infographic)

10,000-plus medical charts provides comparator for HIV prevention study in pregnant women

Fact Sheet: The MTN-042B Sub-study of DELIVER (MTN-042)

The DELIVER and B-PROTECTED Studies: Preventing HIV in Pregnant and Breastfeeding Women

Researchers launch DELIVER study to assess safety of PrEP and dapivirine vaginal ring in pregnant women

Video about DELIVER and B-PROTECTED in English





Video about DELIVER and B-PROTECTED in Zulu
DELIVER and B-PROTECTED Video Image in Zulu




Video about DELIVER and B-PROTECTED in Luganda
DELIVER and B-PROTECTED Video Image in Luganda





Video about DELIVER and B-PROTECTED in Shona
DELIVER and B-PROTECTED Video Image in Shona




Video about DELIVER and B-PROTECTED in Chichewa
Video about DELIVER and B-PROTECTED Image in Chichewa





See Also
MTN-042 Study Page

Meeting Report: Stakeholders Consultation on MTN-042

MTN-042B Study Page

MTN-043 (B-PROTECTED) Study Page