Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease

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.

NCT Number	NCT07666048
Lead Sponsor	Children's Hospital Medical Center, Cincinnati Collaborators: American Heart Association, Menzies School of Health Research, University of Washington, Uganda Heart Institute, Federal University of Minas Gerais
Conditions	Rheumatic Heart Disease in Children
Enrollment	308 participants
Start Date	2026-08-01
Primary Completion	2030-04-30 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-13