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NCT Number: NCT05504928

Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease

The overall objective is to evaluate the effectiveness of a school-centered primary and secondary prevention program on the prevalence of latent rheumatic heart disease among schoolchildren in Nepal, and to investigate the role of socioeconomic and environmental factors in the development and progression of rheumatic heart disease.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulsi Secondary Boarding School

Tulsi̇̄pur, 22412, Nepal

Location status: Recruiting

Location contact

Krishna Agrawal, Prof. Dr.

CONTACT

[email protected]

+9779857045721

About this study

Three in four children worldwide grow up in regions of the world where patterns of acute rheumatic fever and rheumatic heart disease are endemic and where rheumatic heart disease accounts for >300'000 deaths every year. Evidence from a systematic review and meta-analysis of 10 studies indicated an incidence of group A β-hemolytic streptococcal (GAHBS) pharyngitis among children in low- to upper-middle income countries of 10.8 per 100 child-years with considerable heterogeneity between individual reports.

Timely detection of GAHBS pharyngitis by use of rapid antigen detection tests and initiation of antibiotic treatment represents an effective target for primary prevention. Early stages of rheumatic heart disease manifest with morphologic or functional valvular changes that can only be detected with echocardiography and are therefore latent. Latent stages of rheumatic heart disease are reversible with timely initiation of secondary antibiotic prophylaxis. A school-centered approach provides an opportunity to provide equitable access to a primary and secondary prophylaxis program with the potential to substantially reduce the burden of rheumatic heart disease in endemic regions.

All children 5-16 years of age from Tulsi Secondary Boarding School in Tulsipur, Nepal, will be eligible for inclusion. Sociodemographic characteristics and will be collected by means of a standardized interview. In a study using an interrupted time series design, prevalence of latent rheumatic heart disease will be measured by means of transthoracic echocardiography before, and two and four years after implementation of a dedicated school nurse program providing health care through assessment, intervention and follow-up of GAHBS pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.

Investigators expect to find a decrease in prevalence of rheumatic heart disease after implementation of a dedicated school-centered prevention program primarily led by school nurses, and to identify sociodemographic and environmental factors associated with the development and progression of rheumatic heart disease.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 5-16 years
  • Attending Tulsi Secondary Boarding School in Tulsipur, Nepal.

Exclusion criteria

  • Children / primary caregivers not providing informed consent to participate
  • Children not attending Tulsi Secondary Boarding School in Tulsipur.

Treatment and study plan

School nurse program

Other

School nurse program providing health care through assessment, intervention and follow-up of group A β-hemolytic streptococcal pharyngitis and facilitation of secondary antibiotic prophylaxis for children with latent rheumatic heart disease.

Primary outcomes

  1. Prevalence of definite or borderline Rheumatic Heart Disease

    Time frame: 4 years

    Prevalence of definite or borderline Rheumatic Heart Disease according to the criteria of the World Heart Federation as assessed by systematic echocardiographic screening

Secondary outcomes

  1. Group A β-hemolytic streptococcal pharyngitis

    Time frame: 4 years

    Number of patients with group A β-hemolytic streptococcal pharyngitis within study participation

  2. Acute rheumatic fever

    Time frame: 4 years

    Number of patients with acute rheumatic fever within study participation

  3. Rheumatic heart disease

    Time frame: 4 years

    Number of patients with rheumatic heart disease within study participation

  4. Adverse reactions to penicillin injections

    Time frame: 4 years

    Number of patients with adverse reactions to penicillin injections within study participation

Study contacts

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

Krishna Agrawal, Prof. Dr.

CONTACT

[email protected]

+977 985 7045721

Thomas Pilgrim, Prof. Dr.

CONTACT

[email protected]

0041316325000

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Effectiveness of a School-centered Primary and Secondary Prevention Program on Prevalence of Latent Rheumatic Heart Disease

Acronym: NEPAL4

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2022
Registry last updated
Aug 17, 2022

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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