Rheumatic Heart Disease in ChildrenPREVENTNCT06720272
School-based Program for the Prevention of Rheumatic Heart Disease in Endemic Regions
A study testing School nurse program in people with Rheumatic Heart Disease in Children, run by Thomas Pilgrim at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease in Children
- What is being tested?
- School nurse program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-16 years
Who cannot join
- Children / primary caregivers not providing informed consent to participate
- Children not attending one of the selected schools
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Thomas Pilgrim Bern University Hospital, Bern, Switzerland contact
2 sites in 2 countries
Nepal1 site, 1 recruiting
- Recruiting
National Academy od Medical Sciences
Kathmandu
Kunjang Shrestha, MD
Poonam Sharma, MD
Zambia1 site, 1 recruiting
- Recruiting
Centre of Infectious Disease Research
Lusaka
Guy K Muula
About this study
Official title: Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
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.
- Conditions
- Rheumatic Heart Disease in Children
- Being tested
- School nurse program
- Keywords
- rheumatic heart disease, valvular heart disease, prevention, streptococcal pharyngitis, rheumatic fever
- Medical subject headings
- Rheumatic Heart Disease, Heart Valve Diseases, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School nurse programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| School nurse program | Experimental | 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. Receives: Other: School nurse program |
| Standard of care | No intervention | No school nurse prorgam. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatic heart disease
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.
Measured: The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Dec 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Pilgrim
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, National Academy of Medical Sciences, Nepal, University of Oxford
- Responsible party
- Sponsor-investigator, Thomas Pilgrim, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720272
- Sponsor's protocol ID
- PREVENT
- Acronym
- PREVENT
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06720272
- Acronym / sponsor ID
- PREVENT / PREVENT
- Conditions
- Rheumatic Heart Disease in Children
- Keywords
- rheumatic heart disease, valvular heart disease, prevention, streptococcal pharyngitis, rheumatic fever
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Thomas PilgrimUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, National Academy of Medical Sciences, Nepal, University of Oxford
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| School nurse program | Experimental | Other: School nurse programThe 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. |
| Standard of care | No intervention | –No school nurse prorgam. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 5-16 years
Key exclusion criteria (2 listed)
- Children / primary caregivers not providing informed consent to participate
- Children not attending one of the selected schools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School nurse programThe 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. | Other | School nurse program |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rheumatic Heart Disease in Children
Not yet recruitingObservational study
Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease
Rheumatic Heart Disease in Children
Not yet recruitingPhase 3
ACT4RHD is an Open-label, Randomised, Adaptive Platform Trial to Evaluate Novel and Repurposed Clinical Interventions for Patients With Acute Rheumatic Fever and Carditis. ACT4RHD Seeks to Determine Whether These Interventions Reduce RHD Severity at 6 Months.
Rheumatic Fever, Rheumatic Heart Disease in Children
Not yet recruitingPhase 3
Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children
Rheumatic Heart Disease in Children
Not yet recruitingObservational study
Multi-country Evaluation of Early RHD in Children Across Africa for Vaccine Trial Readiness
Rheumatic Heart Disease in Children
Recruiting
Screening for Disorders of Lipid Metabolism and Familial Hyperlipidemia in Children and Adolescents With Increased Cardiovascular Risk Due to Chronic Diseases Such as Congenital Heart Disease, Chronic Inflammatory Bowel Disease, Celiac Disease and Rheumatic Disorders
Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Pilgrim Bern University Hospital, Bern, Switzerland contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School nurse program in people with Rheumatic Heart Disease in Children, run by Thomas Pilgrim at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal, Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Pilgrim Bern University Hospital, Bern, Switzerland (+41 31 632 08 27, thomas.pilgrim@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.