Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda

NCT07606131 | Not Yet Recruiting

• 1 other identifier: 2026-0306
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatic Heart Disease

Keywords

Rheumatic heart disease; SHIELD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time (days) from positive screen to confirmatory echocardiography

  9 months

Study Arms (4)

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.

Other: The ACT+ Strategy

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.

Interventions

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).

Healthcare Facilities will receive ACT+ Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent/legal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months
• Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study
• Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care
• Ability to provide informed consent in Acholi, Luo, or English
• Employed as a Regional ACT Nurse at the time of study
• Has familiarity with ADUNU program
• Ability to provide informed consent in Acholi, Luo, or English
• Employed at District Health Office within an ADUNU-participating district
• Has familiarity with ADUNU program
• Ability to provide informed consent in Acholi, Luo, or English

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Uganda Heart Institute: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrea Beaton

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Brigham

CONTACT

513-517-1307; isabella.aspromonte@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)