Group Antenatal Care in Ghana: Protocol for a Cluster Randomized Controlled Trial.

Background: While group antenatal care (ANC) has been delivered and studied in high-income countries for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. Although the experimental design of the studies from high-resource countries have been scientifically rigorous, findings cannot be generalized to low-resource countries with low literacy rates and high rates of maternal and newborn morbidity and mortality. The Group Antenatal Care Delivery Project (GRAND) is a collaboration between the University of Michigan in the United States and the Dodowa Health Research Centre in Ghana. GRAND is a 5-year, cluster randomized controlled trial (RCT). Our intervention--group ANC--consists of grouping women by similar gestational ages of pregnancy into small groups at the first ANC visit. They then meet with the same group and the same midwife at the recommended intervals for care. Objective: This study aims to improve health literacy, increase birth preparedness and complication readiness, and optimize maternal and newborn outcomes among women attending ANC at seven rural health facilities in the Eastern Region of Ghana. Methods: Quantitative data will be collected at four time points using a secure web application for data collection and a database management tool. Data will be analyzed on an intention-to-treat basis to test the differences between the two arms: women randomized to group-based ANC and women randomized to routine individual ANC. We will conduct a process evaluation concurrently to identify and document patient, provider, and system barriers and facilitators to program implementation. Results: The study was funded in September 2018. Recruitment and enrollment of participants and data collection started in July 2019. In November 2021, we completed participant enrollment in the study (n=1761), and we completed data collection at the third trimester in May 2022 (n=1284). Data collection at the additional three time points is ongoing: 6 weeks postpartum, 6 months postpartum, and 1 year postpartum. Conclusions: This study is significant and timely because it is among the first RCTs to be conducted to examine the effects of group ANC among low-literacy and nonliterate participants. Our findings have the potential to impact how clinical care is delivered to low-literacy populations, both globally and domestically, to improve maternal and newborn outcomes. [ABSTRACT FROM AUTHOR]