Evaluation of the feasibility, acceptability, and impact of Group Antenatal Care at the health post level on continuation in antenatal care and facility based delivery in Ethiopia using a cluster randomized stepped-wedge design: Study protocol

Adequate antenatal care (ANC) and facility-based delivery are linked to improved maternal and neonatal outcomes. Adequate antenatal care attendance and facility birth rates are increasing in Ethiopia but remain well below national goals and global recommendations. Group ANC (G-ANC), when implemented at higher level facilities, is associated with improved quality and experience of ANC, and increased ANC retention and facility-based delivery. The objectives of the study are to assess the feasibility, acceptability, and impact of G-ANC implemented at lower-level facilities (health posts) on ANC continuation and facility-based delivery. G-ANC will first be piloted in five purposively selected health posts. The study will then use a stepped-wedge design in 36 health posts under six health centers, with randomization of the order of the start of the intervention done at the health center level (clusters). The design will include three time periods: first is a six-month control period with no G-ANC implementation, followed by another six months period where G-ANC will be introduced in half (n=18) of the study health posts, then final six months where G-ANC will be implemented in the remaining 18 health posts. Quantitative and qualitative data collection approaches will be used. The study has "pause and reflect" points designed to iterate on the intervention before rolling out to the next set of sites. Qualitative research will be conducted using in-depth interviews with pregnant women, health care workers, facility managers, and regional health managers. 770 women will be enrolled across all phases. The study will inform decision makers locally and globally on whether G-ANC is a feasible service delivery model at the health post level. Effectiveness of G-ANC at increasing ANC retention and facility-based delivery will be reported, as well as its acceptability to pregnant women and Health Extension Workers. NCT05054491, ClinicalTrials.gov (September 23 rd 2021).