Context and settings
RECRUITMENT
A detailed description of PROMISE-EPI intervention has been described elsewhere (Since inclusion in the PROMISE-EPI study was at 6 weeks post-partum, HEUs were assumed to be taking the three drug prophylaxis from birth as per national guidelines, until recruitment into the study. Thereafter, infants in the intervention group whose mother had an unsuppressed viral load (≥1000cp/mL) switched to lamivudine. Mothers received appropriate counseling on how to administer the drug, and monthly drug refill visits were scheduled. A syringe was provided, clearly marking the volume of drug to withdraw, according to the baby’s weight. The doses, to be given twice daily, were divided into 3 weight bands: 0.75 mL if 2 to 4 kg; 2.5 mL if 4 to 8 kg; 5 mL if >8 kg. Infants of mothers newly unsuppressed at 6 months initiated lamivudine at that particular visit. Infants in the intervention group whose mothers had a viral load <1,000 cp/mL were referred to the national program for discontinuation of the three drug prophylaxis. All children were followed until they were 12 months old.