Rheumatic Heart DiseaseSHIELD 2NCT07606131
Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda
A study testing The ACT+ Strategy in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease
- What is being tested?
- The ACT+ Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUganda
- Study dates
- 1 Dec 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Show all 12Show fewer
- 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
Who cannot join
- No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Uganda Heart Institute
Kampala
Jafes Pulle, 0784936334, jpulle@rrcuganda.org
Jafes Pulles
About this study
Official title: Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda
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
- Being tested
- The ACT+ Strategy
- Keywords
- Rheumatic heart disease, SHIELD
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ACT+ StrategyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Uganda Heart Institute
- Responsible party
- Sponsor
- Investigators
- Andrea Beaton, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606131
- Sponsor's protocol ID
- 2026-0306
- Acronym
- SHIELD 2
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda
- ClinicalTrials.gov ID
- NCT07606131
- Acronym / sponsor ID
- SHIELD 2 / 2026-0306
- Conditions
- Rheumatic Heart Disease
- Keywords
- Rheumatic heart disease, SHIELD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Uganda Heart Institute
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: The ACT+ StrategyThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ACT+ StrategyThe 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). | Other | Healthcare Facilities will receive ACT+ Intervention |
Primary outcome
Facility-level linkage to confirmation rate
Time frame: 9 months
The proportion of individuals with a positive ADUNU screening result who complete confirmatory echocardiography within the 9-month intervention period.
1 secondary outcome
Time (days) from positive screen to confirmatory echocardiography
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Beaton principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ACT+ Strategy in people with Rheumatic Heart Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabella Brigham (513-517-1307, isabella.aspromonte@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facility-level linkage to confirmation rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.