Developing a surveillance system for HIV pre-exposure prophylaxis (PrEP) use in pregnancy in Malawi

Abstract Background Pregnant and breastfeeding women are at elevated risk of HIV acquisition. The World Health Organization (WHO) recommends use of oral TDF/FTC and long-acting injectables cabotegravir (CAB-LA) and lenacapavir (LEN) for HIV pre-exposure prophylaxis (PrEP) in pregnancy. However, safety data for emerging regimens remain limited due to the exclusion of pregnant women from early clinical trials and insufficient routine, program-embedded surveillance, especially in resource-constrain