Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"

NCT05276999 | Completed

• 1 other identifier: 2021-0026
• Study Type: interventional
• Target: 66,123
• Locations: 1 country
• Sites: 1

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. 1.To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention.
2. 2.To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

  2 year endpoint

Study Arms (3)

Echocardiographic Screening of school age children

EXPERIMENTAL

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.

Other: Healthcare provider education; Other: Community Awareness campaign

Healthcare worker knowledge

EXPERIMENTAL

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

Other: Healthcare provider education

Health seeking behavior in the community

EXPERIMENTAL

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

Other: Community Awareness campaign

Interventions

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

Echocardiographic Screening of school age children; Healthcare worker knowledge

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.

Echocardiographic Screening of school age children; Health seeking behavior in the community

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Has agreed to participate in the study via the study's informed consent/assent process.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Uganda Heart Institute: collaborator
• Children's National Research Institute: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Z Beaton

  Cincinnati Chidren's hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: March 14, 2022
• Study Start: January 31, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)