The MONARCH intervention to enhance the quality of antenatal and postnatal primary health services in rural South Africa: protocol for a stepped-wedge cluster-randomised controlled trial

Abstract

Background: Gaps in maternal and child health services can slow progress towards achieving the Sustainable Development Goals. The Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care (MONARCH) study will evaluate a Continuous Quality Improvement (CQI) intervention targeted at improving antenatal and postnatal health service outcomes in rural South Africa where HIV prevalence among pregnant women is extremely high. Specifically, it will establish the effectiveness of CQI on viral load (VL) testing in pregnant women who are HIV-positive and repeat HIV testing in pregnant women who are HIV-negative.

Methods: This is a stepped-wedge cluster-randomised controlled trial (RCT) of 7 nurse-led primary healthcare clinics to establish the effect of CQI on selected routine antenatal and postnatal services. Each clinic was a cluster, with the exception of the two smallest clinics, which jointly formed one cluster. The intervention was applied at the cluster level, where staff received training on CQI methodology and additional mentoring as required. In the control exposure state, the clusters received the South African Department of Health standard of care. After a baseline data collection period of 2 months, the first cluster crossed over from control to intervention exposure state; subsequently, one additional cluster crossed over every 2 months. The six clusters were divided into 3 groups by patient volume (low, medium and high). We randomised the six clusters to the sequences of crossing over, such that both the first three and the last three sequences included one cluster with low, one with medium, and one with high patient volume. The primary outcome measures were (i) viral load testing among pregnant women who were HIV-positive, and (ii) repeat HIV testing among pregnant women who were HIV-negative. Consenting women ≥18 years attending antenatal and postnatal care during the data collection period completed outcome measures at delivery, and postpartum at three to 6 days, and 6 weeks. Data collection started on 15 July 2015. The total study duration, including pre- and post-exposure phases, was 19 months. Data will be analyzed by intention-to-treat based on first booked clinic of study participants.

Discussion: The results of the MONARCH trial will establish the effectiveness of CQI in improving antenatal and postnatal clinic processes in primary care in sub-Saharan Africa. More generally, the results will contribute to our knowledge on quality improvement interventions in resource-poor settings.

Trial registration: This trial was registered on 10 December 2015: www.clinicaltrials.gov, identifier NCT02626351 .

Keywords: Continuous quality improvement; HIV; Health systems; Maternal; Randomised trial; Stepped wedge.

Conflict of interest statement

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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Figures

Fig. 1

The Africa Health Research Institute study site at Somkhele. Location of the MONARCH study. Based on: Tanser et al. 2008 [46]

Fig. 2

The MONARCH stepped wedge study design. Clinics provided baseline (pre-intervention) data until each rolled over to the intervention in random order. All clinics provided data continuously throughout the study period. Baseline data collection across all clinics occurred from 15 July 2015 to 28 September 2015 (Step 0). As data extraction on antenatal visits was retrospective from the point of delivery, the baseline observation period covered an additional ~ 6 months for the first recruited participants – thus Step 0 covered a duration of ~ 8 months