title: 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
creator: Chetty, Terusha
creator: Yapa, H. Manisha N.
creator: Herbst, Carina
creator: Geldsetzer, Pascal
creator: Naidu, Kevindra K.
creator: De Neve, Jan-Walter
creator: Herbst, Kobus
creator: Matthews, Philippa
creator: Pillay, Deenan
creator: Wyke, Sally
creator: Bärnighausen, Till
subject: 610
subject: 610 Medical sciences Medicine
description: 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  .
publisher: BioMed Central
date: 2018
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/25443/1/12913_2018_Article_3404.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-254437
identifier:   Chetty, Terusha ; Yapa, H. Manisha N. ; Herbst, Carina ; Geldsetzer, Pascal ; Naidu, Kevindra K. ; De Neve, Jan-Walter ; Herbst, Kobus ; Matthews, Philippa ; Pillay, Deenan ; Wyke, Sally ; Bärnighausen, Till  (2018) 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.  BMC Health Services Research, 18 (625).  pp. 1-10.  ISSN 1472-6963     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/25443/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng