An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi

Abstract

Background: Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for two-thirds of new HIV infections and 25% of preterm births. Antenatal care, as the entry point into the health system for many women, offers an opportunity to provide life-saving monitoring, health promotion, and health system linkages. Change is urgently needed, because potential benefits of antenatal care are not realized when pregnant women experience long wait times and short visits with inconsistent provisioning of essential services and minimal health promotion, especially for HIV prevention. This study answers WHO's call for the rigorous study of group antenatal care as a transformative model that provides a positive pregnancy experience and improves outcomes.Methods: Using a hybrid type 1 effectiveness-implementation design, we test the effectiveness of group antenatal care by comparing it to individual care across 6 clinics in Blantyre District, Malawi. Our first aim is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We will test hypotheses using multi-level hierarchical models using data from repeated surveys (four time points) and health records. Guided by the consolidated framework for implementation research, our second aim is to identify contextual factors related to clinic-level degree of implementation success. Analyses use within and across-case matrices. Discussion: This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care. Results will provide rigorous evidence documenting the effectiveness and scalability of group antenatal care. If results are negative, governments will avoid spending on less effective care. If our study shows positive health impacts in Malawi, the results will provide strong evidence and valuable lessons learned for widespread scale-up in other low-resource settings. Positive maternal, neonatal, and HIV-related outcomes will save lives, impact the quality of antenatal care, and influence health policy as governments make decisions about whether to adopt this innovative healthcare model. Trial registration: ClinicalTrials.gov registration number NCT03673709. Registered on September 17, 2018.

Experiential Training Workshops for Group Antenatal Care in Malawi

“…Our randomized pilot showed that Group ANC+ was feasible and acceptable and had promise for positive outcomes such as satisfaction and attendance 27 . We are now in the fifth year of an adequately powered effectiveness‐implementation study that is assessing a range of outcomes of Group ANC+ in a randomized trial while documenting implementation processes in Blantyre District, Malawi 28 . Results from the current study are forthcoming.…”

Acceptability and feasibility of a screening protocol for antenatal depression (SPADe) in Blantyre District, Malawi

“…In addition, Group Antenatal Care (GANC) was considered as a framework for task sharing which was potentially feasible and acceptable for integrating mental health screening and services into maternal health care at the community level in rural Mali [32]. GANC is currently being implemented in Malawi in a clinical trial [47] and it is anticipated that the SPADe will be integrated in GANC in future as part of a scaling up process. This approach will provide an opportunity for implementing locally informed and delivered screening programmes in the country.…”

Impact of group prenatal care on key prenatal services and educational topics in Malawi and Tanzania

“…Perhaps the more significant finding is that in both of these African countries the standard model of PNC did not. These promising pilot results have led to a large randomized clinical trial on group PNC in Malawi 23 . Several large studies of group care are ongoing in Ghana, Kenya, Nigeria, and Rwanda with large samples, and three of these have already reported positive outcomes, including more PNC attendance and more facility births 21,24–27 .…”

“…These promising pilot results have led to a large randomized clinical trial on group PNC in Malawi. 23 Several large studies of group care are ongoing in Ghana, Kenya, Nigeria, and Rwanda with large samples, and three of these have already reported positive outcomes, including more PNC attendance and more facility births. 21,[24][25][26][27] This growing body of evidence will allow policy makers to determine whether the group care model should become the standard of care to provide higher quality care and a positive pregnancy experience for women in low-resource countries in Africa and globally.…”