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Rheumatic Heart Disease Community Streptococcal Treatment Program RESET

Rheumatic Heart Disease Community Streptococcal Treatment Program RESET

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05276999
Enrollment
66123
Registered
2022-03-14
Start date
2022-01-31
Completion date
2024-03-30
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Heart Disease

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.

Interventions

OTHERHealthcare provider education

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

OTHERCommunity Awareness campaign

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.

Sponsors

Uganda Heart Institute
CollaboratorOTHER
Children's National Research Institute
CollaboratorOTHER
Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Determination of Echocardiography prevalence of RHD among children 5-15 years old2 year endpointEchocardiography screening of school age children in Uganda to determine prevalence of RHD prior to and 2 years post intervention

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026