School-based Program for the Prevention of Rheumatic Heart Disease in Endemic Regions

Not Applicable

Not yet recruiting

• Conditions: Rheumatic Heart Disease in Children

• Registration Number: NCT06720272
• Lead Sponsor: Thomas Pilgrim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Study Start: 2024-12-15
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Rheumatic heart disease	The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.	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.