In April, MTN held a stakeholders’ consultation in Johannesburg on MTN-042, a Phase IIIb study that will evaluate the maternal and infant safety of daily oral PrEP and the monthly dapivirine vaginal ring during pregnancy. The meeting was a unique opportunity to share information about the study design, its objectives and overall scientific framework, as well as address questions about specific aspects of the study. The consultation, which MTN hosted with AVAC, was held two days prior to the MTN-042 protocol development team meeting so that stakeholder feedback could be considered in those deliberations.
MTN-042, which will be conducted at 4 African sites, will enroll 750 pregnant women who are HIV-uninfected at different times during their pregnancy and who will be randomly assigned to use either PrEP or the ring until delivery. Stakeholders attending the meeting included Institutional Research Board/Ethics Committee members and administrators; Ministry of Health representatives; World Health Organization representatives; researchers, civil society and advocates focused on HIV prevention and women’s reproductive health and empowerment; ethicists; national HIV program officers; and NGO representatives with experience working with pregnant women. The 35 attendees hailed from Malawi, South Africa, Uganda and Zimbabwe.