Enhancing Blood Donation at Schools and Beyond in Malawi

Blood Donation Clinical Trial

Official title:

Enhancing Blood Donation Rates at Schools and Beyond Using Club 25 Blood Donor Program in Malawi: An Implementation Science Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06138899
• Other study ID #: B10
• Secondary ID: 5UH3HL152189-04
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: August 1, 2027

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Recognizing the role of youth in blood donation, Zimbabwe, a country with similar demographics to Malawi, developed "Club 25" in 1989 as a means to encourage regular blood donation among the youth. Club 25 donation programs involved students pledging to donate blood 25 times in their lifetime. In order to achieve this objective, students pledged to lead a healthy lifestyle, to avoid acquiring HIV and other TTIs and to continue donating blood after leaving school. Club 25 in Zimbabwe demonstrated a consistent drop in HIV infection among donors over time and managed to minimize blood shortages during school holidays.

This is a hybrid Type I implementation science cluster randomized clinical trial comparing an enhanced Malawian-tailored school-based Club 25 donation program to the current standard procedures (SP) for student blood donor recruitment in 30 secondary schools in Malawi. This study will be conducted for 3 years, with additional 6 months start-up and 6-month data analysis/write up (total activity period will be 4 years). The total sample size is 11,492 per year. A minimum of 5746 student voluntary non-numerated blood donors (VNRBD) from each arm (15 schools with standard procedures for blood donor recruitment (SP) and 15 Club 25 schools) will be recruited annually. Focus group discussions, in-depth interviews, and key informant interviews will be conducted with a minimum of 400 participants including student VNRBDs, key informants, and community stakeholders. Schools will be stratified by Malawi Blood Transfusion Service regional office sites (South, East, Centre, North).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35000
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Blood Donation

Intervention

Other:
• Club 25
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.

Locations

Country	Name	City	State
Malawi	Malawi Blood Transfusion Services	Lilongwe

Sponsors (5)

Lead Sponsor	Collaborator
University of Minnesota	Malawi Blood Transfusion Services (MBTS), Ministry of Health, Malawi, National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donation rate	Blood donation rate per year among secondary students	36 months
Secondary	Students who donated at least once	Proportion of the students who donated blood at least once during the course of the study	36 months