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OpenTrials
Completed

NCT Number: NCT05276999

Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

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.

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Key information

Conditions

Rheumatic Heart Disease Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Diseases Infections Rheumatic Fever Streptococcal Infections

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uganda Heart Institute

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Healthcare provider education

Other

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

Community Awareness campaign

Other

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Children's National Research Institute
  • Uganda Heart Institute

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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