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

NCT06720272 | Recruiting DMC

• 1 other identifier: PREVENT
• Study Type: interventional
• Target: 6,000
• Locations: 2 countries
• Sites: 2

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.

Conditions

Rheumatic Heart Disease in Children

Keywords

rheumatic heart disease; valvular heart disease; prevention; streptococcal pharyngitis; rheumatic fever

Outcome Measures

Primary Outcomes (1)

• 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.

  The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.

Study Arms (2)

School nurse program

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

No school nurse prorgam.

Interventions

School nurse program OTHER

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.

School nurse program

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Children aged 5-16 years

You may not qualify if:

• Children / primary caregivers not providing informed consent to participate
• Children not attending one of the selected schools

Sponsors & Collaborators

• University of Oxford: collaborator
• Thomas Pilgrim: lead
• National Academy of Medical Sciences, Nepal: collaborator
• Centre for Infectious Disease Research in Zambia (CIDRZ): collaborator

Study Sites (2)

National Academy od Medical Sciences

Kathmandu, Nepal

RECRUITING

Centre of Infectious Disease Research

Lusaka, Zambia

RECRUITING

MeSH Terms

Conditions

Rheumatic Heart Disease; Heart Valve Diseases; Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Thomas Pilgrim Bern University Hospital, Bern, Switzerland

CONTACT

+41 31 632 08 27; thomas.pilgrim@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

NE (1); ZA (1)