MCH-ART Intervention
SECONDARY
Women who attended the immediate postpartum study visit and were currently breastfeeding [471 (75%) of 628 women enrolled into antenatal follow-up] were enrolled into postpartum follow-up and randomly allocated. Random allocation was to the MCH-ART intervention (integrated concurrent and co-located maternal ART and paediatric care in the MCH clinic through the end of breastfeeding) or the standard of care (control), where women were referred as soon as possible postpartum to general HIV clinics, and their infants were referred to routine child health services. Although all postpartum women may benefit from integrated HIV and MCH care, the goal of this trial was to focus on breastfeeding women, given the ongoing risk of mother-to-child transmission (MTCT). Thus, only breastfeeding women were enrolled into the trial; a secondary aim of the trial was to explore the impact of the intervention on breastfeeding practices. Women subsequently attended up to five study measurement visits separate from any routine health services, at 6 weeks and 3, 6, 9 and 12 months postpartum. This analysis includes all women with primary outcome data available at 12 months postpartum [411 (87%) of 471 women enrolled]. All participants provided written informed consent prior to study enrolment. The study was approved by the Faculty of Health Sciences Human Research Ethics Committee at the University of Cape Town, and the Institutional Review Board of Columbia University Medical Centre.