An implementation research programme to support an intravenous iron intervention for pregnant women with moderate and severe anaemia in Malawi: study protocol

BACKGROUND: Antenatal iron supplementation is critical to maternal and child health; however, access and adherence to oral iron are inconsistent in many low- and middle-income countries (LMICs). Modern intravenous (IV) iron products have become available in high-income clinical settings and provide an opportunity to deliver high doses of iron in a single-short infusion during pregnancy. However, there is limited knowledge of the drivers and barriers for such an intervention to be effectively delivered and upscaled in LMICs. In this study protocol, we describe the implementation research programme to support an IV iron intervention in Malawi for pregnant women with moderate and severe anaemia. METHODS: The implementation research programme has three phases, each guided by implementation science conceptual frameworks. In Phase 1, we will conduct formative research (context assessment of the health system with key informant interviews) to determine how IV iron can be effectively introduced into routine antenatal care. We will use the findings to co-develop potential strategies with end-users and healthcare providers to improve intervention implementation. In Phase 2, we will disseminate the implementation strategies to support the uptake and delivery of the intervention in the study settings. In Phase 3, the intervention will be implemented, and we will conduct formative evaluation (interviews with end-users, healthcare providers, and analysis of health services data) to investigate the feasibility and acceptability of the intervention and strategies. We will also identify processes and contextual factors that facilitate or impede the delivery and uptake of IV iron. DISCUSSION: In LMICs, modern IV iron products present a novel opportunity to rapidly cure moderate and severe anaemia in pregnancy, thereby improving maternal and child health outcomes. This implementation research programme will provide guidance and recommendations on how best an IV iron intervention for pregnant women with anaemia can be implemented in an LMIC setting like Malawi. We will develop locally relevant and culturally appropriate implementation strategies by engaging with key stakeholders (pregnant women, healthcare providers, and policymakers) and identifying factors likely to facilitate successful implementation. The findings of this research can guide the implementation of an IV iron intervention in Malawi and other LMICs.