An observational study in Rheumatic Heart Disease, sponsored by Centre for Infectious Disease Research in Zambia. Recruiting at 1 site in Zambia. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Centre for Infectious Disease Research in Zambia · Observational
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.
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.
61 studies on the registry are indexed under Rheumatic Heart Disease; 25 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 1,224 across 22 observational studies indexed under Rheumatic Heart Disease.
Browse Rheumatic Heart Disease studies →Centre for Infectious Disease Research in Zambia is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
20000
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To evaluate the effectiveness of an integrated, school-based program for the prevention of RHD in regions with an endemic pattern of RHD.
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.
Time frame: Incidence of newly diagnosed definite or probable rheumatic heart disease during the follow-up period.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre for Infectious Disease Research in Zambia