Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease
Children's Hospital Medical Center, Cincinnati
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.
Description
The first aim will utilize a non-controlled, pre-post design to evaluate CHW-led supports delivered within the community on SAP adherence. The composition of the SAP adherence supports will be finalized prior to implementation and will be comprised of a CHW-delivered package of supports covering patient reminders, education, and connection to care. The final package will reflect solutions that are easy for CHWs to deliver, acceptable to patients and families, and well aligned with local context, resources, and cultural norms. SAP adherence for the 12 months prior to and following intervention…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 pat…
Interventions
- BehavioralCHW Delivered SAP Adherence Supports
A CHW-delivered package of supports covering patient reminders, education, and connection to care. The final composition of the SAP adherence supports will be finalized prior to implementation to ensure alignment with local context, resources, and cultural norms. CHWs will be trained using a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, supervised field practice, and ongoing mentorship to ensure readiness, fidelity, and confidence before delivering the supports.
Location
- Cincinnati Children's Hospital- Heart InstituteCincinnati, Ohio