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

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.

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Key information

Conditions

Rheumatic Heart Disease in Children Arthritis Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Connective Tissue Diseases Gram-Positive Bacterial Infections Heart Diseases Heart Valve Diseases Infections Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatic Fever Rheumatic Heart Disease Skin and Connective Tissue Diseases Streptococcal Infections

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Academy od Medical Sciences, Kathmandu, Nepal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Rheumatic heart disease

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.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Pilgrim Bern University Hospital, Bern, Switzerland

CONTACT

[email protected]

+41 31 632 08 27

Sponsors and collaborators

Lead sponsor

Thomas Pilgrim

Other

Collaborators

Centre for Infectious Disease Research in Zambia
National Academy of Medical Sciences, Nepal
University of Oxford

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Dec 6, 2024
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed