Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Not Applicable

Completed

• Conditions: Rheumatic Heart Disease
• Interventions: Other: Healthcare provider education; Other: Community Awareness campaign

• Registration Number: NCT05276999
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

The primary objective of this study is to determine the impact of a pragmatic RHD primary prevention program in Uganda.

The secondary Objective are as follow:

1. To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention.

2. To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

Detailed Description

Our intervention is designed as a service-oriented plan to be implemented through the primary healthcare structure and facilities of both the national health and private system. Additional support will come from the education system, with participation from schools, teachers, patients, patient families, and the public. Our intervention will focus on two of the more easily rectified impediments to primary prevention, namely (1) poor uptake of guideline-based treatments for Group A Streptococcal (GAS) pharyngitis and (2) low levels of public awareness of the importance of sore throat care and treatment.

Study Timeline

• Study First Submitted: 2022-01-14
• Study Start: 2022-01-31
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-14
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66123

Inclusion Criteria

• Has agreed to participate in the study via the study's informed consent/assent process.

Exclusion Criteria

• Known history of ARF or RHD
• Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition,
• among others) that have resulted in prescription of regular antibiotic prophylaxis
• Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echocardiographic Screening of school age children	Healthcare provider education	Echocardiographic screening of school age children in Tororo and Iganga districts in Uganda to measure the prevalence of RHD before and two years after the deployment of an integrated strep infection education and treatment package.
Echocardiographic Screening of school age children	Community Awareness campaign	Echocardiographic screening of school age children in Tororo and Iganga districts in Uganda to measure the prevalence of RHD before and two years after the deployment of an integrated strep infection education and treatment package.
Healthcare worker knowledge	Healthcare provider education	Health care worker representatives from 101 facilities (n=101) will participate in primary educational workshops in identifying and treating GAS pharyngitis.
Health seeking behavior in the community	Community Awareness campaign	To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign that includes school based education, VHT lead education, education of patients seeking evaluation of sore throat at HC, and public service announcements

Primary Outcome Measures

Name	Time	Method
Determination of Echocardiography prevalence of RHD among children 5-15 years old	2 year endpoint	Echocardiography screening of school age children in Uganda to determine prevalence of RHD prior to and 2 years post intervention

Trial Locations

Locations (1)

Uganda Heart Institute; 🇺🇬 Kampala, Uganda