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

NCT07666048 | Not Yet Recruiting

• 1 other identifier: 2026-0308
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease; SAP for RHD; SAP Adherence; Secondary Antibiotic Prophylaxis Adherence

Outcome Measures

Primary Outcomes (1)

• 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)

  24 months

Secondary Outcomes (4)

• Proportion of participants achieving adequate SAP adherence

  12 months

• Participant engagement with CHW-led support components

  2 months

• Number and type of adaptations made to the intervention

  5 months

• Feasibility of intervention delivery by CHWs

  5 months

Study Arms (2)

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.

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.

Behavioral: CHW Delivered SAP Adherence Supports

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.

Post Intervention Period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• Healthcare workers (HCWs): age ≥18 years; employed at a healthcare center providing care to patients with RHD; able to provide informed consent in English or the local language

You may not qualify if:

• 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
• Healthcare workers: none

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• American Heart Association: collaborator
• Menzies School of Health Research: collaborator
• University of Washington: collaborator
• Uganda Heart Institute: collaborator
• Federal University of Minas Gerais: collaborator

Study Sites (1)

Cincinnati Children's Hospital- Heart Institute

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Sarah de Loizaga, Medical Doctor

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Andrea Beaton, Medical Doctor

  Children's Hospital Medical Center, Cincinnati

  STUDY DIRECTOR

Central Study Contacts

Principal Investigator, Assistant Professor

CONTACT

5136364432; Sarah.deLoizaga@cchmc.org

Isabella Brigham, Bachelor of Science

CONTACT

7202808610; Isabella.Aspromonte@cchmc.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)