[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053888":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":25,"interventions":42,"overallOfficials":47,"centralContacts":51,"locations":57,"responsibleParty":76,"collaborators":78,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":17,"maxAge":17,"enrollmentInfo":90,"targetDuration":17,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":102,"whyStopped":17,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Facility-level linkage to confirmation rate","The proportion of individuals with a positive ADUNU screening result who complete confirmatory echocardiography within the 9-month intervention period.","9 months",[14],{"measure":15,"description":16,"timeFrame":12},"Time (days) from positive screen to confirmatory echocardiography","% providers entering \\>90% of screening records OR completing all monthly outreach activities",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","This study employs a sequential, mixed-methods design with two phases corresponding to Aims 1 and 2.\n\nAim 1 - Human-Centered Design (HCD) (Year 1) Aim 1 will use a theory-informed HCD framework to adapt the ACT registry and develop implementation strategies tailored to the Ugandan context.\n\nAim 2 - Hybrid Effectiveness-Implementation Trial (Year 2) Aim 2 will evaluate ACT+ using a mixed-methods, hybrid effectiveness-implementation trial with a cluster randomized controlled design. Sixteen primary healthcare facilities (clusters) will be randomized in a 1:1 ratio to receive ACT+ (intervention arm, n=8) or standard of care (control arm, n=8). The 9-month intervention period will be followed by quantitative and qualitative evaluation.","SCREENING",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE",[26,30,33,39],{"label":27,"type":28,"description":29,"interventionNames":17},"Inspiration\u002FDiscovery (1A)","NO_INTERVENTION","Semi-structured qualitative interviews with screen-positive community members (or parents\u002Fguardians of community members) and ADUNU providers to characterize multilevel barriers and facilitators.",{"label":31,"type":28,"description":32,"interventionNames":17},"Ideation\u002FDesign (1B)","A structured participatory design workshop with a 15-member HCD expert panel, followed by iterative co-design sessions to produce finalized ACT+ features and workflows.",{"label":34,"type":35,"description":36,"interventionNames":37},"Healthcare Facilities will receive ACT+ Intervention","ACTIVE_COMPARATOR","The ACT+ strategy consists of three coordinated, registry-enabled implementation components co-designed and refined through the Aim 1 HCD process.\n\nComponent 1: Digitized Pre-Confirmation Registry Entry and Patient Tracking ACT+ will enable entry of screen-positive individuals into the ACT registry at the time of positive screen (prior to confirmatory diagnosis).\n\nComponent 2: Patient Tracing and Reminder System ACT+ will support automated and semi-automated outreach to screen-positive who have not yet completed confirmatory echocardiography.\n\nComponent 3: Audit and Feedback for Providers and Facilities ACT+ dashboards will provide facility-level, real-time feedback on LTFU rates, confirmation completion, and the screening-to-SAP initiation cascade.",[38],"Other: The ACT+ Strategy",{"label":40,"type":28,"description":41,"interventionNames":17},"Control: Standard of Care","Facilities in the control arm will continue current standard ADUNU practice: screen-positive individuals receive verbal and written referral information to one of three confirmatory sites immediately following screening.",[43],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":17},"The ACT+ Strategy","The Active Community Case Management Tool (ACT) is a cloud-based, dynamic RHD case management tool developed by CCHMC in partnership with global stakeholders, including UHI and the RRCU. ACT provides real-time data on patient status, clinical outcomes, and care processes, supporting both individual patient management (electronic medical record functions) and system-level quality improvement (registry and dashboard functions).",[34],[48],{"name":49,"affiliation":5,"role":50},"Andrea Beaton","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":17,"email":56},"Isabella Brigham","CONTACT","513-517-1307","isabella.aspromonte@cchmc.org",[58],{"facility":59,"status":17,"city":60,"state":17,"zip":17,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Uganda Heart Institute","Kampala","Uganda","UG",{"type":64,"coordinates":65},"Point",[66,67],32.58219,0.31628,{"lat":67,"lon":66},[70,74],{"name":71,"role":54,"phone":72,"phoneExt":17,"email":73},"Jafes Pulle","0784936334","jpulle@rrcuganda.org",{"name":75,"role":50,"phone":17,"phoneExt":17,"email":17},"Jafes Pulles",{"type":77,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[79],{"name":59,"class":6},"100053888","testing-a-registry-based-strategy-act-to-reduce-loss-to-follow-up-in-rheumatic-heart-disease-screening-in-uganda-100053888",false,"NCT07606131","Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda","Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda","SHIELD 2","Inclusion Criteria: Community Members\n\n* 18 years of age or older\n* Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent\u002Flegal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months\n\nInclusion Criteria: Providers\n\n* Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study\n* Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: Regional RHT ACT Nurse Coordinator\n\n* Employed as a Regional ACT Nurse at the time of study\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: District Health Office Team Members and District RHD Focal Persons\n\n* Employed at District Health Office within an ADUNU-participating district\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nExclusion Criteria:\n\n* No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.",true,"ALL",{"count":91,"type":92},16,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.",[98],"Rheumatic Heart Disease",[100,101],"Rheumatic heart disease","SHIELD","NOT_YET_RECRUITING","2026-07-10",{"date":105,"type":106},"2026-07-13","ACTUAL",{"date":108,"type":92},"2026-08-01",{"date":110,"type":92},"2028-06-01",{"name":5,"class":6},1]