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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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