The 4MOTHERS trial of the impact of a mobile money-based intervention on maternal and neonatal health outcomes in Madagascar: study protocol of a cluster-randomized hybrid effectiveness-implementation trial
Authors: Lacroze Etienne , Bärnighausen Till , De Neve Jan Walter , Vollmer Sebastian , Ratsimbazafy Rolland Marie , Emmrich Peter Martin Ferdinand , Muller Nadine , Rajemison Elsa , Rampanjato Zavaniarivo , Ratsiambakaina Diana , Knauss Samuel , Emmrich Julius Valentin 
Published: October 2021

Abstract
Background
Mobile money—a service enabling users to receive, store, and send electronic money using mobile phones—has been widely adopted across low- and middle-income economies to pay for a variety of services, including healthcare. However, evidence on its effects on healthcare access and health outcomes are scarce and the possible implications of using mobile money for financing and payment of maternal healthcare services—which generally require large one-time out-of-pocket payments—have not yet been systematically assessed in low-resource settings. The aim of this study is to determine the impact on health outcomes, cost-effectiveness, feasibility, acceptability, and usefulness of mobile phone-based savings and payment service, the Mobile Maternal Health Wallet (MMHW), for skilled healthcare during pregnancy and delivery among women in Madagascar.

Methods
This is a hybrid effectiveness-implementation type-1 trial, determining the effectiveness of the intervention while evaluating the context of its implementation in Madagascar’s Analamanga region, containing the capital, Antananarivo. Using a stratified cluster randomized design, 61 public-sector primary-care health facilities were randomized within 6 strata to either receive the intervention or not (29 intervention vs. 32 control facilities). The strata were defined by a health facility’s antenatal care visit volume and its capacity to offer facility-based deliveries. The registered pre-specified primary outcomes are (i) delivery at a health facility, (ii) antenatal care visits, and (iii) total healthcare expenditure during pregnancy, delivery, and neonatal period. The registered pre-specified secondary outcomes include additional health outcomes, economic outcomes, and measurements of user experience and satisfaction. Our estimated enrolment number is 4600 women, who completed their pregnancy between July 1, 2020, and December 31, 2021. A series of nested mixed-methods studies will elucidate client and provider perceptions on feasibility, acceptability, and usefulness of the intervention to inform future implementation efforts.

Discussion
A cluster-randomized, hybrid effectiveness-implementation design allows for a robust approach to determine whether the MMHW is a feasible and beneficial intervention in a resource-restricted public healthcare environment. We expect the results of our study to guide future initiatives and health policy decisions related to maternal and neonatal health and universal healthcare coverage through technology in Madagascar and other countries in sub-Saharan Africa.

Trial registration
This trial was registered on March 12, 2021: Deutsches Register Klinischer Studien (German Clinical Trials Register), identifier: DRKS00014928. For World Health Organization Trial Registration Data Set see Additional file 1.