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

Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06720272

Acronym

PREVENT

Enrollment

6000

Registered

2024-12-06

Start date

2024-12-15

Completion date

2028-02-01

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Heart Disease in Children

Keywords

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

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.

Interventions

OTHERSchool nurse program

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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Stepped wedge cluster randomized trial

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Nepal, Zambia

Contacts

CONTACTThomas Pilgrim Bern University Hospital, Bern, Switzerland

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026