Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease (SHIELD 3 Adapt)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatic Heart Disease in Children
• Intervention / Treatment: Behavioral: CHW Delivered SAP Adherence Supports

Detailed Description

The first aim will utilize a non-controlled, pre-post design to evaluate CHW-led supports delivered within the community on SAP adherence. The composition of the SAP adherence supports will be finalized prior to implementation and will be comprised of a CHW-delivered package of supports covering patient reminders, education, and connection to care. The final package will reflect solutions that are easy for CHWs to deliver, acceptable to patients and families, and well aligned with local context, resources, and cultural norms. SAP adherence for the 12 months prior to and following intervention rollout will be captured from facility-based paper records, triangulated with prophylaxis cards of individual patients and the ACT registry once it is established at both sites. At enrollment, each participant will be assigned an anonymized study ID, and demographic data will be collected along with RHD history. CHWs in a ratio of approximately 1:10 patients will be selected for training, with training delivered through a standardized, competency-based curriculum including in-person workshops, practical skill-building sessions, and supervised field practice. Ongoing mentorship will be provided throughout the training period to ensure readiness, fidelity, and confidence before CHWs deliver the intervention.

The second aim will be guided by the Integrative Behavioral Model to examine implementation outcomes and mechanisms underlying behavior change related to SAP adherence. A subset of relevant constructs from the outer and inner setting domains of the Consolidated Framework for Implementation Research will augment the IBM. Participants will include people living with RHD, CHWs, and key informants. Quantitative data collection will include program activity logs completed weekly by participating CHWs and a patient knowledge and perception survey developed locally based on the General Attitudes Towards Medication Questionnaire with additional questions capturing IBM constructs. Semi-structured qualitative interviews will follow best practices, including recording with consent, post-interview debriefing, ongoing reflexivity memoing, and maintenance of detailed memos and field notes. Interview guides informed by the IBM and selected CFIR constructs will address perspectives related to acceptability, feasibility, uptake, and engagement.

Quantitative and qualitative analyses will occur in parallel. Descriptive statistics will summarize survey results and aggregate measures of patient engagement and CHW adoption. Joint displays will be constructed to visually compare qualitative and quantitative findings and examine convergence in themes or patterns. Qualitative data will be analyzed using thematic content analysis, with a codebook developed based on the IBM, CFIR, and open coding of initial interviews. All transcripts will be independently coded deductively by one study team member and reviewed by another, with disagreements resolved by consensus.

• Study Type: Observational
• Enrollment (Estimated): 308

Contacts and Locations

• Study Contact: Name: Principal Investigator, Assistant Professor; Phone Number: 5136364432; Email: Sarah.deLoizaga@cchmc.org
• Study Contact Backup: Name: Isabella Brigham, Bachelor of Science; Phone Number: 7202808610; Email: Isabella.Aspromonte@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital- Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving adequate SAP adherence	Receipt of ≥80% of scheduled secondary antibiotic prophylaxis injections	12 months
Participant engagement with CHW-led support components	Frequency of response to SMS reminders Participation in peer group activities Completion of scheduled CHW contacts	2 months
Number and type of adaptations made to the intervention	Documented modifications using human-centered design methods (e.g., interviews, co-design workshops)	5 months
Feasibility of intervention delivery by CHWs	Proportion of planned CHW activities completed CHW-reported ease of delivery (survey/interviews)	5 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Washington; American Heart Association; Federal University of Minas Gerais; Menzies School of Health Research; Uganda Heart Institute
• Investigators: Principal Investigator: Sarah de Loizaga, Medical Doctor, Children's Hospital Medical Center, Cincinnati; Study Director: Andrea Beaton, Medical Doctor, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease; SAP for RHD; SAP Adherence; Secondary Antibiotic Prophylaxis Adherence
• Other Study ID Numbers: 2026-0308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No