Chetty, Terusha
,
Yapa, H. Manisha N. http://orcid.org/0000-0002-0100-4754
Herbst, Carina
Geldsetzer, Pascal
Naidu, Kevindra K.
De Neve, Jan-Walter
Herbst, Kobus
Matthews, Philippa
Pillay, Deenan
Wyke, Sally
Bärnighausen, Till
Funding for this research was provided by:
European Commission (EuropeAid/134286/L/ACT/ZA-6)
Article History
Received: 19 February 2018
Accepted: 19 July 2018
First Online: 8 August 2018
Ethics approval and consent to participate
: Ethical approval for the study was obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC, ref. BE209/14). Additional BREC approvals at AHRI include approval for the retrospective review of routine clinical data in Hlabisa and Mtubatuba local municipalities (BE 066/07), and linkage of routine ART programme data to the AHRI Demographic Information System (BE 134/06). Prior to commencing the intervention a meeting was held with sub-district and district-level DoH staff to share study objectives and introduce the intervention. This was in addition to standard sub-district and provincial DoH approvals required to commence the study as part of the AHRI Memorandum of Understanding with DoH.The MONARCH trial is registered on www.clinicaltrials.gov (NCT02626351).MCRs were photographed at delivery from eligible women ≥18 years old, excluding the intrapartum section, based on the UKZN BREC waiver of consent for accessing routine DoH data. Consent was obtained from eligible women ≥18 years old for interviews and taking photographs of their infant’s RtHB at delivery, 3–6 day and 6-week postnatal visits. Consent was also obtained from healthcare providers prior to their participation in structured and semi-structured interviews.Whilst this is deemed a low-risk study, an independent Data Safety and Monitoring Board (DSMB) was formed and met twice yearly to review study progress, adherence to the protocol and safety of study participants. All DSMB members (including a biostatistician) are based in South Africa. As the study was not anticipated to cause significant adverse effects, a closed session with by-arm analyses was planned only if concerns were raised on aggregate data (focusing on the primary endpoints) presented at open sessions.
: Not applicable
: The authors declare they have no competing interests.
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