Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Rheumatic Heart Disease

Treatments: Other: Community Awareness campaign; Other: Healthcare provider education

Study type: Interventional

Funder types: Other

Identifiers

NCT05276999

2021-0026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66,123 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66,123 participants in 3 patient groups

Echocardiographic Screening of school age children

Experimental group

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.

Treatment:

Other: Healthcare provider education

Other: Community Awareness campaign

Healthcare worker knowledge

Experimental group

Description:

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

Treatment:

Other: Healthcare provider education

Health seeking behavior in the community

Experimental group

Description:

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

Treatment:

Other: Community Awareness campaign