Clinical trial NCT05504928: Effectiveness of a School-centered Prevention Program on Prevalence of Latent Rheumatic Heart Disease
Official title: Effectiveness of a School-centered Primary and Secondary Prevention Program on Prevalence of Latent Rheumatic Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatic Heart Disease
Rheumatic Heart Disease in Children
Keywords: Rheumatic Heart Disease
Primary Prevention
Secondary Prevention
Screening
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 2300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interrupted time series design
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of definite or borderline Rheumatic Heart Disease
timeFrame: 4 years
Secondary outcomes:
measure: Group A β-hemolytic streptococcal pharyngitis
timeFrame: 4 years
measure: Acute rheumatic fever
timeFrame: 4 years
measure: Rheumatic heart disease
timeFrame: 4 years
measure: Adverse reactions to penicillin injections
timeFrame: 4 years
Other outcomes:
Locations:
city: Tulsipur
country: Nepal
facility: Tulsi Secondary Boarding School
Study officials:
affiliation: Bern University Hospital
name: Thomas Pilgrim, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carapetis JR, Steer AC, Mulholland EK, Weber M. The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005 Nov;5(11):685-94. doi: 10.1016/S1473-3099(05)70267-X.
citation: Marijon E, Mirabel M, Celermajer DS, Jouven X. Rheumatic heart disease. Lancet. 2012 Mar 10;379(9819):953-964. doi: 10.1016/S0140-6736(11)61171-9.
citation: Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
citation: Pearce S, Bowen AC, Engel ME, de la Lande M, Barth DD. The incidence of sore throat and group A streptococcal pharyngitis in children at high risk of developing acute rheumatic fever: A systematic review and meta-analysis. PLoS One. 2020 Nov 18;15(11):e0242107. doi: 10.1371/journal.pone.0242107. eCollection 2020.