Developing, Implementing and Evaluating Effective Community-Facility Interactions to Improve Blood Availability and Transfusion in Three Distinct County Settings in Kenya (CoBAnK): The Kenya BLOODSAFE Protocol for a Hybrid Effectiveness-Implementation Trial (Preprint)

BACKGROUND Kenya faces a persistent shortage in the supply of blood for transfusion, collecting only half its estimated annual need. This shortage critically affects care for patients with conditions relying on timely and adequate blood availability, such as postpartum hemorrhage, severe anemia, or trauma. Factors contributing to persistent blood shortages include limited community awareness of the role of blood in healthcare, reliance on family replacement donors, low rates of voluntary donation, and fragmented governance and coordination across the blood system continuum from donor mobilization to point of care transfusion. OBJECTIVE The CoBAnK study evaluated whether Community-Facility Transfusion Committees (CFTCs), a novel, shared governance model designed to improve linkages between communities and healthcare facilities, can improve blood availability at the point of care. The study assessed the impact of CFTCs on blood request fulfillment, time to transfusion, and patient outcomes, as well as their feasibility, acceptability, fidelity, and sustainability across diverse health system settings. METHODS This was a hybrid effectiveness-implementation cluster-randomized trial across nine sites (transfusing hospitals without an on-site blood bank, and the communities they serve) in three Kenyan counties. Sites were randomized to intervention and control arms. At intervention sites, CFTCs were established with representation from three local blood transfusion stakeholder groups: clinical or laboratory health facility staff, community leaders, and community health workers. Committees received technical and financial support to design and implement initiatives for improving local blood availability. Facilities assigned to the control arm continued their usual blood management and transfusion practices in accordance with current local blood availability conditions, without implementing the CFTC model. The primary effectiveness outcome is the met blood need by crossmatch in transfusing hospitals; secondary effectiveness outcomes are time to transfusion and 14-day patient outcomes. Effectiveness analyses will use regression models for blood requests that account for clustering at the facility level. Co-primary implementation outcomes include acceptability, feasibility, fidelity, and sustainability of the CFTC model. These will be assessed using validated measures guided by the RE-AIM, CFIR and PSE frameworks. Data collected includes structured meeting observations, stakeholder surveys, interviews, and data on individual blood requests. RESULTS Recruitment and data collection are complete. CONCLUSIONS This study evaluates a novel approach to community-engaged governance of health systems to address persistent blood shortages. By linking communities where blood resides with facilities where blood is needed, this intervention aims to enable sustainable, context-specific solutions to chronic blood shortages that affect healthcare systems globally. Findings from this study will inform local, regional, national and global strategies for strengthening blood systems. CLINICALTRIAL ClinicalTrials.gov NCT06142825; clinicaltrials.gov