ClinicalTrials.gg
Not yet recruitingNCT07606131SHIELD 2Updated Oct 13, 2026

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

An interventional study of The ACT+ Strategy in Rheumatic Heart Disease, sponsored by Children's Hospital Medical Center, Cincinnati. Not yet recruiting at 1 site in Uganda. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Screening

Updated Oct 13, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatic Heart Disease

Keywords

  • Rheumatic heart disease
  • SHIELD
03

In context

Rheumatic Heart Disease

61 studies on the registry are indexed under Rheumatic Heart Disease; 25 are open to participants now.

This study's planned enrollment of 16 is below the median of 221 across 37 interventional studies indexed under Rheumatic Heart Disease.

Browse Rheumatic Heart Disease studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Community Members

  • 18 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

Inclusion Criteria: Providers

  • 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 in Acholi, Luo, or English

Inclusion Criteria: Regional RHT ACT Nurse Coordinator

  • 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

Inclusion Criteria: District Health Office Team Members and District RHD Focal Persons

  • 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

Exclusion Criteria:

  • No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • No intervention
    Inspiration/Discovery (1A)

    Semi-structured qualitative interviews with screen-positive community members (or parents/guardians of community members) and ADUNU providers to characterize multilevel barriers and facilitators.

  • No intervention
    Ideation/Design (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.

  • Active comparator
    Healthcare Facilities will receive ACT+ Intervention

    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

  • No intervention
    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.

Interventions

  • OtherThe 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).

06

What researchers measure

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.

    Time frame: 9 months

Secondary outcomes

  1. Time (days) from positive screen to confirmatory echocardiography

    % providers entering \>90% of screening records OR completing all monthly outreach activities

    Time frame: 9 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Dec 2026, on Oct 13, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2026
First posted
May 26, 2026
StartEst.
Dec 1, 2026was Aug 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Jun 1, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Aug 1, 2026→Dec 1, 2026
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Start date Aug 1, 2026→Dec 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07606131
Collaborators
Uganda Heart Institute
Responsible party
Sponsor
First posted
May 26, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Isabella Brigham
Contact
isabella.aspromonte@cchmc.org
513-517-1307
Andrea Beaton
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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