Data safety and monitoring board

In support of the study team, a Data Safety and Monitoring Board (DSMB) comprised of senior South African and US scientists and experts will provide technical inputs to specific aspects of the study. The Chair of the DSMB will be Professor James McIntyre, Ob-Gyn, is the CEO of the Anova Health Institute and Honorary Professor in the School of Public Health & Family Medicine at UCT has significant experience in research on PMTCT and PrEP delivery in SA. Dr. McIntyre has extensive experience in chairing clinical trial DSMBs. Dr. Hasina Subedar (SA National Department of Health, PrEP lead) is the lead on PrEP roll out and guidelines in South Africa. Professor Linda-Gail Bekker (UCT, Desmond Tutu Health Foundation) is a world-renowned clinician, researcher and expert on PrEP and PrEP in adolescences and pregnant women in SA. In addition we will convene a local Community Advisory Board (CAB) in Gugulethu at the beginning of the study with meetings every 6 months to share the study design, study findings and learn more about the community perceptions, barriers and facilitators to maternal PrEP.