Enhancing Blood Donation at Schools and Beyond in Malawi

NCT06138899 | Enrolling By Invitation DMC

• 2 other identifiers: B105UH3HL152189-04
• Study Type: interventional
• Target: 35,000
• Locations: 1 country
• Sites: 1

Brief Summary

First developed in Zimbabwe, Club 25 is an initiative to promote blood donation among young people, who present a low-risk population for the spread of transfusion transmissible infections (TTIs). Club 25 members in Malawi make a pledge to donate blood 25 times during their lifetime. The primary aim of this study is to compare a Club 25 donation program to the current standard procedures for student blood donor recruitment in 30 secondary schools in Malawi. Roughly half of the schools will be randomly assigned to a Club 25 intervention and the study will collect data on student blood donations in all 30 schools for three school years. Upon completion of data collection the rate of student blood donation will be compared between the intervention schools and the non-intervention schools.

Conditions

Blood Donation

Outcome Measures

Primary Outcomes (1)

• Donation rate

  Blood donation rate per year among secondary students

  36 months

Secondary Outcomes (1)

• Students who donated at least once

  36 months

Study Arms (2)

Club 25

EXPERIMENTAL

Club 25 donation programs will be set up in schools randomized to this arm. Three blood donation events per school year will take place at study schools. Each donation event will be preceded by a motivational talk intended to inform students of the importance of blood donation and encourage students to donate blood. Donation events and motivational talks will be planned and conducted by the Malawi Blood Transfusion Services (MBTS).

Other: Club 25

Standard procedures

NO INTERVENTION

Schools in this arm will not take part in a Club 25 donation program. Three blood donation events per school year will take place at study schools. Each donation event will be preceded by a motivational talk intended to inform students of the importance of blood donation and encourage students to donate blood. Donation events and motivational talks will be planned and conducted by the Malawi Blood Transfusion Services (MBTS).

Interventions

Club 25 OTHER

The Club 25 donation program will involve students pledging to donate blood 25 times in their lifetime. In order to achieve this objective, students also pledge to lead a healthy lifestyle, to avoid acquiring HIV and other TTIs and to continue donating blood after leaving school. The Club 25 donation program includes activities in-between blood donation events as well as peer leadership and peer education in schools and in communities.

Club 25

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 16 years old and enrolled in a secondary school

You may not qualify if:

• Under 16 years of age or not enrolled in a secondary school

Sponsors & Collaborators

• University of Minnesota: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Malawi Blood Transfusion Services (MBTS): collaborator
• University of North Carolina, Chapel Hill: collaborator
• Ministry of Health, Malawi: collaborator

Study Sites (1)

Malawi Blood Transfusion Services

Lilongwe, Malawi

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type I implementation-science cluster-randomized clinical trial

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 18, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)