EFFECTIVENESS OF A SCHOOL-CENTRED PRIMARY AND SECONDARY PREVENTION PROGRAM ON PREVALENCE OF LATENT RHEUMATIC HEART DISEASE
Rheumatic Heart Disease
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 5 years - 16 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 20000 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This study consists in an RHD awareness campaign and a school nurse program providing integrated health care through assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with latent RHD.
Read the full description
This study is conducted an incomplete stepped wedge cluster randomized trial in three countries with an endemic pattern of RHD. Individual schools are considered clusters and will be randomly selected from a pool of schools in Kathmandu (Nepal), Lusaka (Zambia), and Mekelle (Ethiopia). The clusters will be randomized to their position stratified by country so that each country has the same number of schools in the different phases. There will be three steps and the length of each step will be one year. Every cluster will provide before and after observations and every cluster will switch from a control phase to an experimental phase according to their randomization result. The experimental phase consists of a school-nurse program accompanied by an awareness program and will be delivered at the level of the cluster. The most important reason to use a stepped wedge rather than a parallel group cluster randomized design is that all included children attending participating schools will eventually benefit from the school-based prevention program.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Age 5-16 years
- Attending a randomly selected school at one of the three study sites
Exclusion Criteria:
- Children / primary caregivers not providing informed consent to participate.
- Children not attending one of the selected schools
Study population
20000
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
To evaluate the effectiveness of an integrated, school-based program for the prevention of RHD in regions with an endemic pattern of RHD.
Time frame: Incidence of newly diagnosed definite or probable rheumatic heart disease during the follow-up period.
The primary measures is to acertain the Incidence of definite or probable RHD among participating school-aged children during the study follow-up period. Incidence of new echocardiographically detected RHD among children who were free of RHD at baseline. Incidence of RHD per 1,000 person-years, comparing children in the intervention group with those in the control/usual-care group.
The incidence of newly diagnosed definite or probable RHD among participants who do not have definite or probable RHD at baseline. RHD status will be determined using echocardiographic assessment according to the study-defined diagnostic criteria. The outcome will be reported as the number and percentage of participants developing new RHD in each study group during the 24-month follow-up period.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
KalingalingaLusaka, Lusaka Province, ZambiaRecruiting
Study team and timeline
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Study start
- Jan 14, 2025 Actual
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- Dec 31, 2027 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
EFFECTIVENESS OF A SCHOOL-CENTRED PRIMARY AND SECONDARY PREVENTION PROGRAM ON PREVALENCE OF LATENT RHEUMATIC HEART DISEASE
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026