EFFECTIVENESS OF A SCHOOL-CENTRED PRIMARY AND SECONDARY PREVENTION PROGRAM ON PREVALENCE OF LATENT RHEUMATIC HEART DISEASE (PREVENT RHD)

November 4, 2026 updated by: Centre for Infectious Disease Research in Zambia

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.

Study Overview

Status

Recruiting

Conditions

Rheumatic Heart Disease

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guy Kayeye Muula, MD, MPH
Phone Number: 0971747550
Email: Guy.Muula@cidrz.org

Study Locations

Zambia
- Lusaka Province
  - Lusaka, Lusaka Province, Zambia, 10101
    - Recruiting
    - Kalingalinga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20000

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: CROSS_SECTIONAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Incidence of newly diagnosed definite or probable rheumatic heart disease during the follow-up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Infectious Disease Research in Zambia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)