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

Thomas Pilgrim

Status: Enrolling

Conditions: Rheumatic Heart Disease in Children

Treatments: Other: School nurse program

Study type: Interventional

Funder types: Other

Identifiers

NCT06720272

PREVENT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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6,000 participants in 2 patient groups

School nurse program

Experimental group

Description:

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.

Treatment:

Other: School nurse program

Standard of care

No Intervention group

Description:

No school nurse prorgam.