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.
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
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
Children's Hospital Medical Center, Cincinnati
Lead sponsor
American Heart Association
Collaborator
Menzies School of Health Research
Collaborator
University of Washington
Collaborator
Uganda Heart Institute
Collaborator
Federal University of Minas Gerais
Collaborator