School-based program to prevent rheumatic heart disease in children in endemic regions
Official title: Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
Run by Insel Gruppe AG, University Hospital Bern · NCT06720272 · Data updated 2026-11-12
The program will try to prevent rheumatic heart disease in schoolchildren aged 5–16 by placing trained nurses in schools to teach about strep throat, provide assessment and treatment, and help ensure ongoing antibiotic prevention for those at risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 16 Years |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Kathmandu and 1 other locations) |
| Status | Recruiting |
| Started | December 15, 2024 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06720272 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 5–16 who attend one of the selected participating schools in the trial and whose caregivers provide informed consent.
✕Probably not a fit
Children who do not attend the selected schools, whose caregivers do not consent, or who already have advanced, irreversible valve damage are unlikely to benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This stepped-wedge cluster randomized trial introduces a dedicated school-nurse program in randomly selected schools in Nepal and Zambia. The school-level intervention provides education about rheumatic heart disease, assessment and management of group A streptococcal pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD. Schools crossover from usual care to the nurse-led program in a randomized sequence, permitting comparison over time and across sites. The trial enrolls children aged 5–16 who attend participating schools with caregiver consent.
Why it matters
Potential benefit: If successful, the program could reduce new cases and progression of rheumatic heart disease by improving early detection, timely treatment of strep throat, and adherence to antibiotic prophylaxis.
How similar studies have gone: Previous school-based screening and antibiotic prophylaxis programs have shown benefits in endemic areas, though randomized stepped-wedge evaluations of nurse-led school programs are relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Children aged 5-16 years Exclusion Criteria: * Children / primary caregivers not providing informed consent to participate * Children not attending one of the selected schools
Where it's running
-
National Academy od Medical Sciences
Kathmandu, Nepal Recruiting -
Centre of Infectious Disease Research
Lusaka, Zambia Recruiting
Study contacts
- Study coordinator: Thomas Pilgrim Bern University Hospital, Bern, Switzerland
- Email: thomas.pilgrim@insel.ch
- Phone: +41 31 632 08 27
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.