Developing, Implementing and Evaluating Effective Community-facility Interactions to Improve Blood Availability and Transfusion in Three Distinct County Settings in Kenya (CoBAnK)

Developing, Implementing and Evaluating Effective Community-facility Interactions to Improve Blood Availability and Transfusion in Three Distinct County Settings in Kenya (CoBAnK): A Type III Hybrid Effectiveness-implementation Trial.

The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Transfusion
• Intervention / Treatment: Other: Community-Facility Transfusion Committee (CFTC)

Detailed Description

The strategy of the CoBAnK study is to establish and enable the function of Community-Facility Transfusion Committees (CFTCs) incorporating diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care. The CFTC strategy will be evaluated across nine transfusing facilities across three counties in Kenya (two intervention and one control site in each county). While the intervention will be tested in "beta" facilities (i.e., facilities without a co-located blood bank) in each county, blood availability will also be measured in "alpha" facilities (i.e., facilities with co-located blood banks) in the three counties, which supply blood to the beta facilities.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Eligibility criteria for study sites (beta hospitals):

• Transfusing hospital at level 3 or higher
• Has conducted at least 20 blood transfusions in the preceding year
• Does not have a KTTA-approved blood bank (regional or satellite) in the facility premises
• Receives blood from a blood bank at an Alpha Facility in the same county

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: CFTC; Community-Facility Transfusion Committees (CFTCs) will be established at the facilities randomized to this arm.	Other: Community-Facility Transfusion Committee (CFTC); Community-Facility Transfusion Committees (CFTCs) are intended to incorporate diverse representation involving hospital, community, and county leadership, to improve blood availability and transfusion at the point-of-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Met blood need	The proportion of transfusion requests resulting in dispatch of blood products from the laboratory	The time required for the hospital laboratory to process a request for blood for transfusion, up to two weeks.

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Pittsburgh; Strathmore University; Center for Public Health and Development, Kenya (CPHD)

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): June 11, 2026
• Study Completion (Estimated): June 11, 2026

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: B09; 5UH3HL151595-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No