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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-16
SponsorThomas Pilgrim

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Children / primary caregivers not providing informed consent to participate

Children not attending one of the selected schools

Trial design

Design model

Sequential

Treatments tested in this trial

  • School nurse program

    Other intervention

    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.

Treatment groups

6,000 Participants
are divided into 2 treatment groups
Group A: School nurse programExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Pilgrim

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Sponsor institution

Centre for Infectious Disease Research in Zambia (CIDRZ)

Collaborator

National Academy of Medical Sciences, Nepal

Collaborator

University of Oxford

Collaborator