Integrated Bite Case Management within a One Health Framework for Rabies Elimination at the Primary Care Level in Kerala, India: An Implementation Research Protocol Using a Stepped-Wedge Cluster Randomized Design

Abstract Background Rabies remains a persistent public health threat in India, while gaps in surveillance and coordination of control measures undermine progress towards ending human rabies deaths. The World Health Organization advocates a One Health approach, combining mass dog vaccination, post-exposure prophylaxis (PEP), and Integrated Bite Case Management (IBCM). IBCM is not yet incorporated into India’s national rabies action plan for rabies elimination (NAPRE). This study seeks to generate robust evidence on the effectiveness, cost-effectiveness, feasibility, facilitators and barriers of IBCM implemented within Kerala’s Rabies Control Program. Methods This will be an implementation-research, adopting a stepped-wedge cluster randomized controlled trial (RCT) design. IBCM will be implemented across six administrative blocks in Thiruvananthapuram District, Kerala, across diverse rural and urban settings, and including tribal population representation. The IBCM intervention includes stakeholder training and support, and active animal surveillance aligned with WHO guidance. Suspect or probable rabies exposures presenting at selected health facilities and identified via a community-based hotline will trigger investigations and responses including dog vaccination and sensitization. Prior to IBCM implementation, baseline data will be collected on management of dog bites, bite patient incidence and health case seeking behaviours. Hospital-based event tracking of bite cases will be conducted at enrolled public health facilities before and after IBCM implementation. The resulting RCT data will be used to model the impacts and cost-effectiveness of IBCM, including the potential for cost savings through judicious PEP, if scaled up across Kerala. To understand the barriers and facilitators to IBCM implementation, we will use in-depth interviews and focus group discussions with stakeholders. Discussion There is an urgent need to strengthen rabies surveillance, including coordination across health and animal health sectors and outbreak responses to accelerate rabies elimination. IBCM is expected to lead to improved PEP completion, increased detection and laboratory confirmation of rabid dogs, strengthened dog vaccination coverage, and targeted outbreak responses in high-risk areas. This RCT will provide critical evidence to inform policy, support scale-up, generate insights into contextual barriers and facilitators for IBCM implementation, and guide India’s One Health rabies elimination strategy. Unlike the Goa model that relies on hotline reporting, this study evaluates a health-sector–initiated IBCM approach that identifies cases through dog-bite patients presenting to health facilities, enabling more comprehensive One Health integration and greater event capture. Trial registration CTRI registration No. REF/2024/04/081804