Study Design and Settings
AIDS, MTCT
AIDS
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network's Promoting Maternal and Infant Survival Everywhere (PROMISE) 1077BF study was an open-label, multicomponent randomized controlled trial to determine the optimal mART and infant prophylaxis strategies to prevent MTCT and preserve maternal health and infant survival. Enrollments into this trial were conducted between June 2011 and October 2014 at 14 research sites in 7 countries (India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe); the follow-up continued through September 2016. The postpartum component of PROMISE was designed to compare the efficacy and safety of triple mART versus daily iNVP prophylaxis for the prevention of MTCT through breastfeeding (BF), among women with CD4 cell count > 350 cells/mm