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

NCT07666048 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 308

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Rheumatic Heart Disease in Children

Interventions

BEHAVIORAL

CHW 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.

Sponsors & Collaborators

  • American Heart Association

    collaborator OTHER

  • Menzies School of Health Research

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Uganda Heart Institute

    collaborator OTHER

  • Federal University of Minas Gerais

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Sarah de Loizaga, Medical Doctor · Children's Hospital Medical Center, Cincinnati

  • Andrea Beaton, Medical Doctor · Children's Hospital Medical Center, Cincinnati

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2030-04-30
Completion
2030-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666048 on ClinicalTrials.gov