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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07666048). StuddyBuddy aggregates publicly available trial information.