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

BackgroundGaps 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.MethodsThis 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.DiscussionThe 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 registrationThis trial was registered on 10 December 2015: www.clinicaltrials.gov, identifier NCT02626351.Electronic supplementary materialThe online version of this article (10.1186/s12913-018-3404-3) contains supplementary material, which is available to authorized users.

Infant feeding knowledge and practice vary by maternal HIV status: a nested cohort study in rural South Africa

“…Median age was 25 years (interquartile range [IQR], [21][22][23][24][25][26][27][28][29][30]. Median gestation at first ANC visit was 19 weeks (IQR 15-24 weeks).…”

“…Women were aged ≥18 years at delivery and recruited at three time points independent of previous or future recruitment: delivery, the 3-6 day postnatal visit, and the 6-week postnatal immunisation visit [26]. Women who were recruited at more than one time point were linked within the study database.…”

“…Women who were recruited at more than one time point were linked within the study database. Women were recruited at delivery if they were resident within the AHRI population surveillance area during pregnancy or attended one of the seven study clinics during pregnancy [26]. At postnatal visits, women who attended a study clinic were recruited regardless of their antenatal clinic or area of residency.…”

“…Structured interviews of consenting women conducted at delivery, the 3-6 day postnatal visit and the 6-week postnatal visit were sourced for demographic data and the endpoints listed above. The delivery and 3-6 day postnatal interviews were identical and included a theme on knowledge of infant feeding (Table S1), whereas the 6-week postnatal interview covered knowledge of HIV treatment and transmission, and self-reported practices of infant feeding (Table S1) [26]. We selected the 6-week interview for HIV treatment and transmission knowledge questions for the following reasons: (i) we were concerned women may find such questions too stressful to handle shortly after giving birth, and (ii) the 6-week postnatal visit was the next scheduled routine clinic visit (aligned with infant immunisation) following the 3-6 day postnatal visit.…”

“…Women's knowledge of infant feeding recommendations, knowledge of HIV, and actual feeding practices therefore reflect quality of healthcare services. We tested whether a continuous quality improvement (CQI) intervention (MONARCH, www.clinicaltrials.gov: NCT02626351) could improve antenatal HIV services in public sector primary care clinics [26,27]. The pre-registered primary endpoints were HIV viral load monitoring among pregnant women living with HIV and repeat HIV testing among pregnant women not living with HIV; the primary findings are reported elsewhere: briefly, CQI improved viral load monitoring but not repeat HIV testing [27].…”