PMID- 30089485 OWN - NLM STAT- MEDLINE DCOM- 20190207 LR - 20240330 IS - 1472-6963 (Electronic) IS - 1472-6963 (Linking) VI - 18 IP - 1 DP - 2018 Aug 8 TI - 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. PG - 625 LID - 10.1186/s12913-018-3404-3 [doi] LID - 625 AB - 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 . FAU - Chetty, Terusha AU - Chetty T AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. FAU - Yapa, H Manisha N AU - Yapa HMN AUID- ORCID: 0000-0002-0100-4754 AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. myapa@ahri.org. FAU - Herbst, Carina AU - Herbst C AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. FAU - Geldsetzer, Pascal AU - Geldsetzer P AD - Department of Global Health and Population, Harvard T. H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA. FAU - Naidu, Kevindra K AU - Naidu KK AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. AD - Maternal Adolescent and Child Health Systems (MatCH), School of Public Health, University of Witswatersrand, Braamfontein, South Africa. FAU - De Neve, Jan-Walter AU - De Neve JW AD - Institute of Public Health, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. FAU - Herbst, Kobus AU - Herbst K AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. FAU - Matthews, Philippa AU - Matthews P AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. FAU - Pillay, Deenan AU - Pillay D AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. AD - Division of Infection & Immunity, University College London, Gower Street, Bloomsbury, London, WC1E 6BT, UK. FAU - Wyke, Sally AU - Wyke S AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. AD - Institute for Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, Scotland, UK. FAU - Barnighausen, Till AU - Barnighausen T AD - Africa Health Research Institute, Somkhele, P.O. Box 198, Mtubatuba, KwaZulu-Natal, 3935, South Africa. AD - Department of Global Health and Population, Harvard T. H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA. AD - Institute of Public Health, Heidelberg University, Im Neuenheimer Feld 324, 69120, Heidelberg, Germany. AD - Department of Global Health, University College London, Gower Street, Bloomsbury, London, WC1E 6BT, UK. CN - MONARCH study team LA - eng SI - ClinicalTrials.gov/NCT02626351 GR - D43 TW009775/TW/FIC NIH HHS/United States GR - R01 HD084233/HD/NICHD NIH HHS/United States GR - R01 AI124389/AI/NIAID NIH HHS/United States GR - WT_/Wellcome Trust/United Kingdom GR - P01 AG041710/AG/NIA NIH HHS/United States GR - R01 AI112339/AI/NIAID NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20180808 PL - England TA - BMC Health Serv Res JT - BMC health services research JID - 101088677 SB - IM MH - Adult MH - Cluster Analysis MH - Data Accuracy MH - Data Collection MH - Female MH - HIV Infections/diagnosis MH - Humans MH - Multicenter Studies as Topic MH - Postnatal Care/*standards MH - Pregnancy MH - Pregnancy Complications, Infectious/diagnosis/nursing MH - Prenatal Care/*standards MH - Prenatal Diagnosis/standards MH - Primary Health Care/standards MH - Quality Improvement MH - Randomized Controlled Trials as Topic MH - Rural Health Services/standards MH - South Africa MH - Young Adult PMC - PMC6083494 OTO - NOTNLM OT - Continuous quality improvement OT - HIV OT - Health systems OT - Maternal OT - Randomised trial OT - Stepped wedge COIS- 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. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/08/10 06:00 MHDA- 2019/02/08 06:00 PMCR- 2018/08/08 CRDT- 2018/08/10 06:00 PHST- 2018/02/19 00:00 [received] PHST- 2018/07/19 00:00 [accepted] PHST- 2018/08/10 06:00 [entrez] PHST- 2018/08/10 06:00 [pubmed] PHST- 2019/02/08 06:00 [medline] PHST- 2018/08/08 00:00 [pmc-release] AID - 10.1186/s12913-018-3404-3 [pii] AID - 3404 [pii] AID - 10.1186/s12913-018-3404-3 [doi] PST - epublish SO - BMC Health Serv Res. 2018 Aug 8;18(1):625. doi: 10.1186/s12913-018-3404-3.