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NCT Number: NCT07606131

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uganda Heart Institute

Kampala, Uganda

Location contact

Jafes Pulle

CONTACT

[email protected]

0784936334

Jafes Pulles

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent 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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabella Brigham

CONTACT

[email protected]

513-517-1307

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Uganda Heart Institute

Registry information

Official study 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

Acronym: SHIELD 2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 26, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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