Cluster randomised trial to improve Maternal and Newborn Health through capacity-building interventions to community health workers and other resources in Sidama Regional state, Ethiopia (The SiMaNeH-Trial).

Background:  Health Extension workers and other community-based resources that contribute to the health system in rural communities in Ethiopia are expected to provide preventative, promotive, and curative maternal and child healthcare services at the community level. However, their roles in the continuum of care during pregnancy and childbirth require critical improvement through capacity-building approaches.

Experiences and studies show that health extension workers lack the knowledge and skills to provide adequate support during pregnancy and childbirth. As a result, the federal Ministry of Health has taken various measures to improve the capacity of these community health workers.  However, the quality of maternal and neonatal health care services still needs to improve in Ethiopia. Furthermore, the COVID-19 pandemic and current conflicts in Ethiopia could disrupt the hard-won health gains and services.

Objectives:

• To implement and evaluate the effects of a set of capacity-building interventions that target community health workers and other resources in the community, such as the women development army and key public figures,
• To improve maternal and newborn survival and health in Sidama regional state between 2022 and 2024.

Methods: A cluster randomised controlled trial will be conducted in selected (20 intervention and 20 control) kebeles as clusters that serve as randomisation units. In this trial, the interventions will target community and community health workers, where the effects will be assessed at the individual level (mothers, newborns, and health workers). Accordingly, all community health workers and households with pregnancies that consent to participate in the study will be included.

The proposed 40 clusters (kebeles) have an estimated population of 300,000 people, giving an estimated 10,000 deliveries per year. At the district and kebele levels, 1897 pregnant women will be recruited using a two-stage cluster sampling method. Forty clusters (20 kebeles for intervention and 20 kebeles for control groups) and 47 eligible pregnant women will be randomly assigned within each selected kebele. For the intervention group, capacity-building interventions will be done for two weeks for health extension workers and three days of refresher training twice every three months for the health development team.  In addition, basic medical supplies and materials will be provided for all health posts in the selected intervention kebeles. The control clusters will continue using the standard care.

Data will be collected through face-to-face interviewing of pregnant and postnatal mothers using structured tools, observation of the recorded documents using checklists, and review of health service records.  We will implement an intention-to-treat analysis of the trial data. We will use the intention-to-treat analysis. The cost-effectiveness of the intervention will also be analysed.

Keywords: quality improvement, maternal, neonatal health care service.

The researchers include Dr Achamyelesh Gebretsadik (project leader), Yaliso Yaya  (Associate Professor), Yemisrach Shiferaw PhD student) and Hirut Gemeda (PhD student)