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

Conditions

• Rheumatic Heart Disease in Children

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• CHW Delivered SAP Adherence Supports — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Jun 2026

Primary completion

Apr 30, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

308 participants (estimated)

Arms

• Arm: Pre Intervention
  Participants contribute SAP adherence data during the 12-month pre-intervention period. Adherence will be captured from facility-based paper records, triangulated with prophylaxis cards of individual patients and the ACT registry once established. Demographic data and RHD history will be collected at enrollment, and each participant will be assigned an anonymized study ID. This arm reflects routine care prior to the rollout of CHW-delivered SAP adherence supports.
• Arm: Post Intervention Period
  Participants contribute SAP adherence data during the 12-month post-intervention period after implementation of a CHW-delivered package of supports. The support package will be finalized prior to implementation and will include patient reminders, education, and connection to care. 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 intervention.

Primary Outcome Measure

Feasibility and acceptability of the adapted CHW-led SAP support intervention [ Time Frame: 24 months ]

Central Contacts

• Principal Investigator, Assistant Professor
  5136364432
  [email protected]
• Isabella Brigham, Bachelor of Science
  7202808610
  [email protected]

Locations (1)

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