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
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.
Other
Prospective
CHW Delivered SAP Adherence Supports
BehavioralA 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.
Feasibility and acceptability of the adapted CHW-led SAP support intervention
Proportion of participants reporting the intervention as acceptable (e.g., via standardized acceptability surveys) Proportion of intended intervention components successfully implemented (fidelity/adoption)
Proportion of participants achieving adequate SAP adherence
Receipt of ≥80% of scheduled secondary antibiotic prophylaxis injections
Participant engagement with CHW-led support components
Frequency of response to SMS reminders Participation in peer group activities Completion of scheduled CHW contacts
Number and type of adaptations made to the intervention
Documented modifications using human-centered design methods (e.g., interviews, co-design workshops)
Feasibility of intervention delivery by CHWs
Proportion of planned CHW activities completed CHW-reported ease of delivery (survey/interviews)
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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
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