The PEPI-Malawi study is a randomized, open-label, controlled phase III trial of extended post-exposure prophylactic antiretrovirals to prevent breastmilk-associated HIV transmission.

The study population consists of women and their babies attending antenatal clinics and/ or admitted to labor rooms at the Queen Elizabeth Central Hospital in Blantyre and 5-6 township health centers in southern Malawi. Women attending antenatal clinics in their second or early third trimesters of pregnancy and those who present for delivery at the labor ward will be targeted for recruitment into the study. Women interested in participation will receive one-on-one counseling on breastfeeding, risk of HIV/AIDS transmission and infant feeding options, in addition to HIV testing and counseling. Counseling includes details of the study such as HIV virus found in breastmilk, and the potential to transmit the virus to their infants. Participants are educated on ways to minimize transmission risk by ceasing to breastfeed or how the risk can also be reduced by exclusively breastfeeding versus mixed feeding. Comprehensive counseling is also conducted to educate the mothers on infant feeding including all breastfeeding options and replacement feeding options.

Newton Kumwenda, PhD, Principal Investigator
Taha E. Taha, MD, PhD, Co-Investigator