Actively Recruiting
Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
Led by Thomas Pilgrim · Updated on 2026-01-20
6000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Thomas Pilgrim
Lead Sponsor
C
Centre for Infectious Disease Research in Zambia (CIDRZ)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a school-based program aimed at preventing rheumatic heart disease (RHD) in areas where the disease is common. This trial uses a stepped wedge cluster randomized design involving randomly selected schools in Nepal and Zambia. The goal is to see if an integrated school nurse program can reduce the occurrence of RHD among children. The intervention introduces a dedicated school nurse program that provides education about RHD, assesses and manages group A beta-hemolytic streptococcal (GABHS) pharyngitis, and supports secondary antibiotic prevention for children with RHD. Schools either receive this nurse program or continue with the usual care without the nurse program. The intervention is delivered at the school level. Participants aged 5 to 16 years will be monitored for the development of rheumatic heart disease for at least one year and up to three years after the school nurse program starts. Assessments include diagnosis, intervention, and follow-up of throat infections and facilitation of preventive antibiotic use. The study tracks the presence of RHD as the main outcome measure. The total duration of participation varies by each school’s timing in the stepped wedge design.
CONDITIONS
Brief Title
School-based Program for the Prevention of Rheumatic Heart Disease in Endemic Regions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5-16 years
You will not qualify if you...
- Children or primary caregivers who do not provide informed consent to participate
- Children not attending one of the selected schools
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 years
Participants in the experimental group receive a school nurse program that provides education about rheumatic heart disease, assessment, intervention, and follow-up of group A beta-hemolytic streptococcal pharyngitis, and facilitates secondary antibiotic prophylaxis for children with rheumatic heart disease.
Ongoing school-based interactions as part of the program
Duration - Up to 3 years after intervention starts
Participants are monitored to assess the effectiveness of the school nurse program in preventing rheumatic heart disease.
Periodic assessments during the study period
Trial Site Locations
Total: 2 locations
1
National Academy od Medical Sciences
Kathmandu, Nepal
Actively Recruiting
2
Centre of Infectious Disease Research
Lusaka, Zambia
Actively Recruiting
Research Team
T
Thomas Pilgrim Bern University Hospital, Bern, Switzerland
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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