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| Name | Class |
|---|---|
| Uganda Heart Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiration/Discovery (1A) | No Intervention | Semi-structured qualitative interviews with screen-positive community members (or parents/guardians of community members) and ADUNU providers to characterize multilevel barriers and facilitators. | |
| Ideation/Design (1B) | No Intervention | 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. | |
| 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. Component 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). Component 2: Patient Tracing and Reminder System ACT+ will support automated and semi-automated outreach to screen-positive who have not yet completed confirmatory echocardiography. Component 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. |
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| Control: Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ACT+ Strategy | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) from positive screen to confirmatory echocardiography | % providers entering >90% of screening records OR completing all monthly outreach activities | 9 months |
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Inclusion Criteria: Community Members
Inclusion Criteria: Providers
Inclusion Criteria: Regional RHT ACT Nurse Coordinator
Inclusion Criteria: District Health Office Team Members and District RHD Focal Persons
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella Brigham | Contact | 513-517-1307 | isabella.aspromonte@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Beaton | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uganda Heart Institute | Kampala | Uganda |
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| ID | Term |
|---|---|
| D012214 | Rheumatic Heart Disease |
| ID | Term |
|---|---|
| D012213 | Rheumatic Fever |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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This study employs a sequential, mixed-methods design with two phases corresponding to Aims 1 and 2.
Aim 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.
Aim 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.
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |