Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"
June 3, 2024 updated by: Children's Hospital Medical Center, Cincinnati
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:
- To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention.
- To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
66123
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kampala, Uganda
- Uganda Heart Institute
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-
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 15 years (Child)
Accepts Healthy Volunteers
Yes
Description
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 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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Echocardiographic Screening of school age children
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.
|
Mix of training and educational activities within the district continuing medical education system targeting community health workers and frontline providers focused on the importance of sore throat and it's link to RHD, clinical guidelines to differentiate patients at high or low risk for GAS pharyngitis and guideline based care for treating GAS pharyngitis
A district wide public health campaign to increase community awareness of sore throat, including school based education, VHT community sensitization, education of parents and patients, radio messaging, posters, signs and billboards.
|
|
Experimental: Healthcare worker knowledge
Health care worker representatives from 101 facilities (n=101) will participate in primary educational workshops in identifying and treating GAS pharyngitis.
|
Mix of training and educational activities within the district continuing medical education system targeting community health workers and frontline providers focused on the importance of sore throat and it's link to RHD, clinical guidelines to differentiate patients at high or low risk for GAS pharyngitis and guideline based care for treating GAS pharyngitis
|
|
Experimental: Health seeking behavior in the community
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
|
A district wide public health campaign to increase community awareness of sore throat, including school based education, VHT community sensitization, education of parents and patients, radio messaging, posters, signs and billboards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determination of Echocardiography prevalence of RHD among children 5-15 years old
Time Frame: 2 year endpoint
|
Echocardiography screening of school age children in Uganda to determine prevalence of RHD prior to and 2 years post intervention
|
2 year endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea Z Beaton, Cincinnati Chidren's hospital
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 31, 2022
Primary Completion (Actual)
March 30, 2024
Study Completion (Actual)
March 30, 2024
Study Registration Dates
First Submitted
January 14, 2022
First Submitted That Met QC Criteria
March 2, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Estimated)
June 4, 2024
Last Update Submitted That Met QC Criteria
June 3, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.