Effectiveness of checklist-based box system intervention (CBBSI) versus routine care on improving utilization of antenatal care visits in Northwest Ethiopia: a cluster randomized controlled trial

BACKGROUND: In Ethiopia, the proportion of mothers who attend the fourth antenatal care visit is lower than the proportion who attend the first visit. Although the reasons for these dropouts were investigated, few studies introduced interventions to promote the fourth antenatal care visit. Hence, the aim of this study was to assess the effectiveness of checklist-based box system intervention on improving fourth antenatal care visit. METHOD: This study employed a double-blind, parallel-group, two-arm cluster randomized controlled trial to compare the effectiveness of checklist-based box system intervention with the usual standard of care as a control arm. Study clusters are assigned to intervention and control arm in 1:1 allocation ratio using simple randomization technique. Pregnant mothers below 16 weeks of gestation were enrolled. Open data kit was used to collect data from the baseline and end-line surveys, and STATA version 15.0 was used to analyse the data. A difference-in-difference estimator was used to compare fourth antenatal care visit between the intervention and control groups across time. Mixed effect multi-level logistic regression was used to examine the relationship between the dependent and independent variables. RESULT: Data were collected from 2224 mothers who belong to 15 intervention and 15 control clusters. The difference in difference estimation resulted in a significant difference (26.1, 95%CI: 18–34%, p < 0.0001) between the intervention and control groups. Similarly, as compared to controls, the fourth antenatal care visit was found significantly higher in the intervention clusters (432 (85.2%) Vs. 297 (53.7%), p < 0.0001)/(AOR:5.69, 95% CI:4.14–7.82). Mothers who were knowledgeable about the services given during antenatal care visits (AOR: 2.31, 95% CI:1.65–3.24) and mothers who had a high level of social support (AOR:1.47, 95% CI: 1.06–2.04) were more likely to attend the fourth antenatal care visit. CONCLUSION: Implementation of checklist-based box system intervention resulted in a statistically significant effect in attendance of fourth antenatal care visit. Community-level variables were found to be more important in explaining variability in the fourth antenatal care visit. It is recommended that the intervention be implemented on a larger scale. TRIAL REGISTRATION: ClinicalTrials.gov, Retrospectively registered on 26/03/2019, with trial registration number-NCT03891030.