We conducted a parallel-arm randomised trial comparing an integrated postnatal care service within the MCH setting for HIV+ mothers and their infants (the MCH-ART intervention) to the local standard of care (SOC, control)—immediate postnatal referral of HIV+ women on ART to general adult ART services and their infants to routine infant follow-up. The trial took place in a subdistrict of Cape Town as described previously [16 (link)]. Within the subdistrict, the study was based at a large, primary-level antenatal and obstetric facility located in a community of approximately 300,000 where levels of both poverty and HIV infection are high; referral was to one of a number of primary care services in the subdistrict [17 ]. The study was registered on ClinicalTrials.gov (NCT01933477); final registration was approved 3 months after the start of enrolment due to an administrative error. The study protocol is provided as S1 Text. The study protocol was approved by the Human Research Ethics Committee of the University of Cape Town Faculty of Health Sciences, as well as by the Institutional Review Board of Columbia University Medical Center.
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