Blood DonationNCT06138899
Enhancing Blood Donation at Schools and Beyond in Malawi
A study testing Club 25 in people with Blood Donation, run by University of Minnesota at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Donation
- What is being tested?
- Club 25
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35,516 participants
- Where
- 1 siteMalawi
- Study dates
- 19 Feb 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 16 years old and enrolled in a secondary school
Who cannot join
- Under 16 years of age or not enrolled in a secondary school
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Blood Donation Rates at Schools and Beyond Using Club 25 Blood Donor Program in Malawi: An Implementation Science Study
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.
Read the detailed 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).
- Conditions
- Blood Donation
- Being tested
- Club 25
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Club 25Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donation rate
Blood donation rate per year among secondary students
Measured: 36 months
Secondary outcomes (1)
Students who donated at least once
Proportion of the students who donated blood at least once during the course of the study
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Feb 2024
- Primary completion24 Dec 2025
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid Type I implementation-science cluster-randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 35,516 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Malawi Blood Transfusion Services (MBTS), University of North Carolina, Chapel Hill, Ministry of Health, Malawi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138899
- Sponsor's protocol ID
- B10
- Other IDs
- 5UH3HL152189-04
- Status last verified
- May 2026
- First submitted
- 3 Nov 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Blood Donation Rates at Schools and Beyond Using Club 25 Blood Donor Program in Malawi: An Implementation Science Study
- ClinicalTrials.gov ID
- NCT06138899
- Acronym / sponsor ID
- B10
- Conditions
- Blood Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35,516 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Malawi Blood Transfusion Services (MBTS), University of North Carolina, Chapel Hill, Ministry of Health, Malawi
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid Type I implementation-science cluster-randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Club 25 | Experimental | Other: Club 25Club 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). |
| 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- At least 16 years old and enrolled in a secondary school
Key exclusion criteria (1 listed)
- Under 16 years of age or not enrolled in a secondary school
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Club 25The 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. | Other | Club 25 |
Primary outcome
Donation rate
Time frame: 36 months
Blood donation rate per year among secondary students
1 secondary outcome
Students who donated at least once
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Blood Donation
Not yet recruiting
Cookies for Platelets
Blood Donation
RecruitingObservational study
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Healthy Volunteer
RecruitingPhase 2/3
Autologous Cold-stored Apheresis Platelets
Bleeding, Platelets
RecruitingPhase 4
Improving White Blood Cell Collection From Healthy Donors
Allogeneic Granulocyte Donation
Enrolling by invitationObservational study
Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development
Healthy Volunteers, Syphilis Serologic Assay Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Club 25 in people with Blood Donation, run by University of Minnesota at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donation rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.