Study outcomes
ADVERSE EVENT, EVENTS, ADVERSE EVENT
The primary study outcome for breastfeeding women is the percentage retained in care at 18-month post-partum. For children and adolescents, the primary outcome is mean adherence to ARV treatment.Adverse events will be monitored through an adverse event form as part of the case report form. Adverse events will be recorded by the data collectors, which are mainly the nurse counsellors in the field sites. Due to the nature of the intervention, we do not expect serious events. An incidental findings policy is in place.