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Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Primary Purpose

Rheumatic Heart Disease

Status

Active

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

Healthcare provider education

Community Awareness campaign

About this trial

This is an interventional prevention trial for Rheumatic Heart Disease

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Uganda Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Echocardiographic Screening of school age children

Healthcare worker knowledge

Health seeking behavior in the community

Arm Description

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.

Health care worker representatives from 101 facilities (n=101) will participate in primary educational workshops in identifying and treating GAS pharyngitis.

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

Outcomes

Primary Outcome Measures

Determination of Echocardiography prevalence of RHD among children 5-15 years old

Echocardiography screening of school age children in Uganda to determine prevalence of RHD prior to and 2 years post intervention

Secondary Outcome Measures

Full Information

NCT ID

NCT05276999

First Posted

January 14, 2022

Last Updated

May 5, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Uganda Heart Institute, Children's National Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05276999

Brief Title

Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Official Title

Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 31, 2022 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Uganda Heart Institute, Children's National Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatic Heart Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Pragmatic public health study to test an integrated strep education and treatment program to reduce echo-detected burden of RHD

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21740 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Echocardiographic Screening of school age children

Arm Type

Experimental

Arm Description

Arm Title

Healthcare worker knowledge

Arm Type

Experimental

Arm Description

Health care worker representatives from 101 facilities (n=101) will participate in primary educational workshops in identifying and treating GAS pharyngitis.

Arm Title

Health seeking behavior in the community

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Healthcare provider education

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Community Awareness campaign

Intervention Description

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.

Primary Outcome Measure Information:

Title

Determination of Echocardiography prevalence of RHD among children 5-15 years old

Description

Echocardiography screening of school age children in Uganda to determine prevalence of RHD prior to and 2 years post intervention

Time Frame

2 year endpoint

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Z Beaton

Organizational Affiliation

Cincinnati Chidren's hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uganda Heart Institute

City

Kampala

Country

Uganda

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

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