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

NCT ID: NCT06720272

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2028-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatic Heart Disease in Children

Keywords

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rheumatic heart disease valvular heart disease prevention streptococcal pharyngitis rheumatic fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped wedge cluster randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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School nurse program

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.

Group Type EXPERIMENTAL

School nurse program

Intervention Type 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.

Standard of care

No school nurse prorgam.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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School 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Infectious Disease Research in Zambia (CIDRZ)

UNKNOWN

Sponsor Role collaborator

National Academy of Medical Sciences, Nepal

OTHER_GOV

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Thomas Pilgrim

OTHER

Sponsor Role lead

Responsible Party

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Thomas Pilgrim

MD, MSc

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Thomas Pilgrim Bern University Hospital, Bern, Switzerland

Role: CONTACT

Phone: +41 31 632 08 27

Other Identifiers

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PREVENT

Identifier Type: -

Identifier Source: org_study_id