An interventional study of School nurse program in Rheumatic Heart Disease in Children, sponsored by Thomas Pilgrim. Recruiting at 2 sites in 2 countries. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Thomas Pilgrim · Not applicable, Interventional, and Prevention
The overall objective of the PREVENT trial is to evaluate the effectiveness of an integrated, school-based program for the prevention of rheumatic heart disease (RHD) in regions with an endemic pattern of RHD.
We conduct a stepped wedge cluster randomized trial in randomly selected schools in Nepal and Zambia.
The intervention will be delivered at the level of the school and consists in the introduction of a dedicated school-nurse program providing health care through education about RHD, assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD.
61 studies on the registry are indexed under Rheumatic Heart Disease; 25 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 221 across 37 interventional studies indexed under Rheumatic Heart Disease.
Browse Rheumatic Heart Disease studies →Thomas Pilgrim is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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- Children aged 5-16 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental intervention consists in a school nurse program providing integrated health care through diagnosis, intervention, and follow-up of group A beta-hemolytic streptococcal pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with rheumatic heart disease.
Other: School nurse program
No school nurse prorgam.
The intervention consists in the introduction of a school-nurse program providing health care through education about rheumatic heart disease, assessment, intervention, and follow-up of group A beta-hemolytic streptococcal pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with rheumatic heart disease.
Rheumatic heart disease
The primary outcome of the study will be the reduction in prevalence of rheumatic heart disease according to WHF criteria 2023 as assessed by systematic echocardiographic screening.
Time frame: The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Feb 2028, 38 months after the start.
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Thomas Pilgrim