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Community health workers may boost antibiotic adherence for rheumatic heart disease

NCT ID NCT07666048

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tests whether community health workers (CHWs) can help people with rheumatic heart disease (RHD) take their monthly antibiotic shots consistently. The trial will enroll about 308 participants in Brazil and Timor-Leste, including adults and children with RHD and their caregivers. CHWs will provide reminders, education, and support. Researchers will compare adherence rates before and after the program to see if it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Community health worker (CHW) delivered support package (reminders, education, connection to care)
What this could lead to
If it works, this could show a practical way to help people with rheumatic heart disease stay on their preventive antibiotics, reducing the risk of serious heart damage.
What could go wrong
This is a relatively small, early-stage implementation study, not a large-scale efficacy trial. Success depends on local context and may not generalize to other settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 308 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes children, adolescents, and adults living with rheumatic heart disease (RHD), their caregivers, community health workers (CHWs), and healthcare workers (HCWs) in Brazil and Timor-Leste. Participants will be recruited from health centers and RHD registries within the public health systems.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults living with rheumatic heart disease (RHD): age ≥18 years; diagnosed with RHD; prescribed secondary antibiotic prophylaxis (SAP) * Guardians of children living with RHD: age ≥18 years; caregiver/guardian of a child aged 5-17 years with diagnosed RHD who is prescribed SAP * Children living with RHD: age 12-17 years; diagnosed with RHD; prescribed SAP * Community health workers (CHWs): age ≥18 years; associated with a healthcare center providing care to patients with RHD * Healthcare workers (HCWs): age ≥18 years; employed at a healthcare center providing care to patients with RHD; able to provide informed consent in English or the local language Exclusion Criteria: * Adults living with RHD: medical contraindication to SAP; inability to provide informed consent (e.g., significant cognitive or communication impairment precluding participation) * Guardians of children living with RHD: child has a medical contraindication to SAP; inability to provide informed consent * Children living with RHD: medical contraindication to SAP; inability to provide informed assent (e.g., significant cognitive or communication impairment precluding participation) * Community health workers: none * Healthcare workers: none

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cincinnati Children's Hospital- Heart Institute

    Cincinnati, Ohio, 45229, United States

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