Developing and testing an optimised implementation model to improve coverage of India’s national anaemia reduction programme among pregnant women in India: A hybrid type II effectiveness-implementation study.

Introduction Maternal anaemia is a major public health challenge globally. In India, it affects over half of all pregnant women and contributes significantly to maternal and neonatal morbidity and mortality. The Government of India launched the “Anaemia Mukt Bharat (AMB)” or “Anaemia Free India” program in 2018, focussing on iron and folic acid (IFA) supplementation and deworming. In Haryana, a northern state of India, 56.5% of pregnant women are anaemic (NFHS-5), indicating a high-burden area. This study aims to design, implement and evaluate an optimised implementation strategy for AMB in a high burden low-resource setting, setting, which will help develop a replicable model for managing this major public health issue through contextual adaptation. Methods and analysis This is a mixed-method, hybrid type II effectiveness–implementation study in Hodal block, Palwal district, of Haryana. The study will be conducted in two phases. Phase I will include formative research using the Consolidated Framework for Implementation Research (CFIR) to identify barriers and enablers, through in-depth interviews, focus groups, and facility assessments. These findings will inform the development of a co-designed implementation model using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Phase II will scale and evaluate the optimised strategy across four clusters, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Primary outcomes are the proportion of pregnant women consuming IFA for at least 100 days and receiving a dose of albendazole. Secondary outcomes include 180-day IFA coverage, haemoglobin change, compliance with AMB treatment protocols, and acceptability and feasibility of strategies. Quantitative data will be analysed using descriptive and inferential statistics, and qualitative data thematically analysed using NVivo. This protocol is reported in accordance with SPIRIT guidelines https://doi.org/10.6084/m9.figshare.31827730. 1