[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054258":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":30,"locations":40,"responsibleParty":54,"collaborators":56,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":10,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":87,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Pre Intervention",null,"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.",{"label":13,"type":10,"description":14,"interventionNames":15},"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.",[16],"Behavioral: CHW Delivered SAP Adherence Supports",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"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.",[13],[24,27],{"name":25,"affiliation":5,"role":26},"Sarah de Loizaga, Medical Doctor","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"Andrea Beaton, Medical Doctor","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Principal Investigator, Assistant Professor","CONTACT","5136364432","Sarah.deLoizaga@cchmc.org",{"name":37,"role":33,"phone":38,"phoneExt":10,"email":39},"Isabella Brigham, Bachelor of Science","7202808610","Isabella.Aspromonte@cchmc.org",[41],{"facility":42,"status":10,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":10},"Cincinnati Children's Hospital- Heart Institute","Cincinnati","Ohio","45229","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-84.51439,39.12711,{"lat":52,"lon":51},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57,59,61,63,65],{"name":58,"class":6},"American Heart Association",{"name":60,"class":6},"Menzies School of Health Research",{"name":62,"class":6},"University of Washington",{"name":64,"class":6},"Uganda Heart Institute",{"name":66,"class":6},"Federal University of Minas Gerais","100054258","adapting-enhanced-supports-to-improve-patient-adherence-to-secondary-antibiotic-prophylaxis-for-rheumatic-heart-disease-100054258",false,"NCT07666048","Adapting Enhanced Supports to Improve Patient Adherence to Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease","SHIELD 3 Adapt","Inclusion Criteria:\n\n* Adults living with rheumatic heart disease (RHD): age ≥18 years; diagnosed with RHD; prescribed secondary antibiotic prophylaxis (SAP)\n* Guardians of children living with RHD: age ≥18 years; caregiver\u002Fguardian of a child aged 5-17 years with diagnosed RHD who is prescribed SAP\n* Children living with RHD: age 12-17 years; diagnosed with RHD; prescribed SAP\n* Community health workers (CHWs): age ≥18 years; associated with a healthcare center providing care to patients with RHD\n* 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\n\nExclusion Criteria:\n\n* Adults living with RHD: medical contraindication to SAP; inability to provide informed consent (e.g., significant cognitive or communication impairment precluding participation)\n* Guardians of children living with RHD: child has a medical contraindication to SAP; inability to provide informed consent\n* Children living with RHD: medical contraindication to SAP; inability to provide informed assent (e.g., significant cognitive or communication impairment precluding participation)\n* Community health workers: none\n* Healthcare workers: none","ALL",{"count":76,"type":77},308,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions it aims to answer are:\n\n* Whether CHW-led supports delivered within the community improve mean SAP adherence at 12 months post-intervention.\n* Whether the intervention demonstrates acceptability, feasibility, uptake and engagement.\n\nResearchers 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.",[81],"Rheumatic Heart Disease in Children",[83,84,85,86],"Secondary Antibiotic Prophylaxis for Rheumatic Heart Disease","SAP for RHD","SAP Adherence","Secondary Antibiotic Prophylaxis Adherence","NOT_YET_RECRUITING","2026-07-10",{"date":90,"type":91},"2026-07-13","ACTUAL",{"date":93,"type":77},"2026-08-01",{"date":95,"type":77},"2030-12-31",{"name":5,"class":6},1]