The protocol for a cluster randomized controlled trial to evaluate couple-based violence prevention education and its ability to reduce intimate partner violence during pregnancy in Southwest Ethiopia

Abstract

Background A significant proportion of women in Ethiopia suffer from violence by their intimate partner during pregnancy, which has adverse maternal and newborn outcomes. Couple-focused interventions are effective in reducing and/or controlling violence between women and their intimate partners. However, interventions addressing intimate partners of the victims are not well studied, particularly in the Ethiopian setting. This study aims to assess the effect of couple-based violence prevention education on intimate partner violence during pregnancy. Methods We will use a cluster randomized controlled trial to evaluate the effectiveness of couple-based violence prevention education compared to routine care in reducing intimate partner violence during pregnancy. Sixteen kebeles will be randomly assigned to 8 interventions and 8 control groups. In the trial, 432 couples whose wife is pregnant will participate. Health extension workers (HEWs) will provide health education. Data will be collected at baseline and endline. All the collected data will be analyzed using Stata version 16.0 or SPSS version 25.0. We will use the McNemar test to assess the differences in outcomes of interest in both intervention and control groups before and after the intervention for categorical data. A paired t-test will be used to compare continuous outcome of interest in the intervention and the control groups after and before the intervention. The GEE (Generalized Estimating Equation), will be used to test the independent effect of the intervention on the outcome of the interest. Data analysis will be performed with an intention-to-treat analysis approach. During the analysis, the effect size, confidence interval, and p-value will be calculated. All tests will be two-sided, and statistical significance will be declared at p < 0.05. Discussion We expect that the study will generate findings that can illuminate violence prevention strategies and practices in Ethiopia. Trial registration It has been registered on ClinicalTrials.gov as NCT 05856214 on May 4, 2023.