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NCT07666048
Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease
Conditions: Rheumatic Heart Disease in Children
Sex: All
Healthy volunteers: No
Enrollment: 308
Sponsor: Children's Hospital Medical Center, Cincinnati
Location: Cincinnati Children's Hospital- Heart Institute Cincinnati Ohio
Summary
The goal of this clinical trial is to test the effectiveness and implementation of enhanced Secondary Antibiotic Prophylaxis (SAP) supports using a hybrid type 1 effectiveness-implementation design. The purpose is to determine whether enhanced SAP supports will increase average SAP adherence in Brazil and Timor-Leste. The study will enroll people living with Rheumatic Heart Disease (RHD) and Community Health Workers (CHWs) participating in the intervention.
The main questions it aims to answer are:
* Whether CHW-led supports delivered within the community improve mean SAP adherence at 12 months post-intervention.
* Whether the intervention demonstrates acceptability, feasibility, uptake and engagement.
Researchers will compare baseline and post-intervention SAP adherence data for the 12 months prior to and following intervention rollout to see if CHW-delivered supports increase adherence.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07666048). StuddyBuddy aggregates publicly available trial information.