Rheumatic Heart DiseaseNCT05276999
Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"
A study testing Healthcare provider education and Community Awareness campaign in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- Healthcare provider education and Community Awareness campaign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66,123 participants
- Where
- 1 siteUganda
- Study dates
- 31 Jan 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Has agreed to participate in the study via the study's informed consent/assent process.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rheumatic Heart Disease
- Being tested
- Healthcare provider education, Community Awareness campaign
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthcare provider educationOther
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 campaignOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: Community Awareness campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 year endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start31 Jan 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 66,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute, Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Andrea Z Beaton, Principal investigator, Cincinnati Chidren's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276999
- Sponsor's protocol ID
- 2021-0026
- Status last verified
- Jun 2024
- First submitted
- 14 Jan 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ndagire E, Rwebembera J, Kaudha G, Pulle J, Nakitto M, Alepere J, Nambogo JL, Fall N, Scheel A, de Loizaga S, Miller M, Atukunda M, Sarnacki R, Zhang N, Ollberding NJ, Sable C, Karthikeyan G, Okello E, Beaton A. Implementation and evaluation of a pragmatic community streptococcal treatment programme to improve rheumatic heart disease primary prevention in Uganda. BMJ Glob Health. 2026 Apr 9;11(4):e018791. doi: 10.1136/bmjgh-2024-018791.
PubMed 41956705
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"
- ClinicalTrials.gov ID
- NCT05276999
- Acronym / sponsor ID
- 2021-0026
- Conditions
- Rheumatic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66,123 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute, Children's National Research Institute
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pragmatic public health study to test an integrated strep education and treatment program to reduce echo-detected burden of RHD
| Arm | Type | Receives |
|---|---|---|
| Echocardiographic Screening of school age children | Experimental | Other: Healthcare provider education, Other: Community Awareness campaignEchocardiographic 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. |
| Healthcare worker knowledge | Experimental | Other: Healthcare provider educationHealth care worker representatives from 101 facilities (n=101) will participate in primary educational workshops in identifying and treating GAS pharyngitis. |
| Health seeking behavior in the community | Experimental | Other: Community Awareness campaignTo 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 |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Has agreed to participate in the study via the study's informed consent/assent process.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthcare provider educationMix 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 | Other | Echocardiographic Screening of school age children, Healthcare worker knowledge |
| Community Awareness campaignA 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. | Other | Echocardiographic Screening of school age children, Health seeking behavior in the community |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 41956705Ndagire E, Rwebembera J, Kaudha G, Pulle J, Nakitto M, Alepere J, Nambogo JL, Fall N, Scheel A, de Loizaga S, Miller M, Atukunda M, Sarnacki R, Zhang N, Ollberding NJ, Sable C, Karthikeyan G, Okello E, Beaton A. Implementation and evaluation of a pragmatic community streptococcal treatment programme to improve rheumatic heart disease primary prevention in Uganda. BMJ Glob Health. 2026 Apr 9;11(4):e018791. doi: 10.1136/bmjgh-2024-018791.
- Individual participant dataSharing planned: No
Related trials for Rheumatic Heart Disease
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruiting
Assessment of the Prevalence of Rheumatic Heart Disease in School Settings in Mayotte and the Acquisition of Ultrasound Sequences Guided by Artificial Intelligence
Rheumatic Heart Diseases, Scabies
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruitingPhase 2
GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial
Rheumatic Heart Disease
Not yet recruiting
Artificial Intelligence to Scale Early Rheumatic Heart Disease Detection
Rheumatic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Z Beaton principal investigator
Cincinnati Chidren's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthcare provider education and Community Awareness campaign in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Echocardiography prevalence of RHD among children 5-15 years old (time frame: 2 year endpoint). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.