Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

NCT ID: NCT05783375

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2028-01-31

Brief Summary

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The goal of this prospective study is to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda.

Detailed Description

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ADUNU is a non-randomized experiment, testing a strategy for implementing an evidence-based practice, decentralized RHD preventive services.

The objectives of the study are to:

Objective 1: Demonstrate the impact of ADUNU, using the RE-AIM framework to assess program Reach, Effectiveness, Adoption, Implementation and Maintenance.

Objective 2: Estimate the cost-effectiveness and budget impact of ADUNU.

ADUNU is a public health initiative that will be deployed the Uganda ministry of health in partnership with the District Health Offices (DHO) in two districts. The program will be overseen by the Technical and Quality Assurance (TAQA). ADUNU's main components will include a RHD testing program which consists of community and facility based echocardiographic screening of children and young adults and a registry based secondary prophylaxis injections of Benzathine penicillin G (BPG) at local health centers III and IVs in both districts.

Conditions

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Rheumatic Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ADUNU Participants

Individuals and healthcare providers residing and working in the involved Ugandan Districts.

Group Type OTHER

ADUNU program for delivery of RHD care services

Intervention Type OTHER

The ADUNU program will be deployed by the Ugandan Ministry of Health and the involved District Health Offices to include echocardiography integrated into primary healthcare to screen for RHD and a registry-based care system to keep patients linked to care and prophylaxis.

Interventions

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ADUNU program for delivery of RHD care services

The ADUNU program will be deployed by the Ugandan Ministry of Health and the involved District Health Offices to include echocardiography integrated into primary healthcare to screen for RHD and a registry-based care system to keep patients linked to care and prophylaxis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* residing in one of two involved districts in Uganda
* providers at HCIIIs and HCIVs located in one of two involved Ugandan districts

Exclusion Criteria

* None
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uganda Heart Institute

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Z Beaton

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Chidren's hospital

Emmy H Okello

Role: PRINCIPAL_INVESTIGATOR

Uganda Heart Institute

David Watkins

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Uganda Heart Institute

Kampala, Uganda, Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Ndate Fall

Role: CONTACT

15135171327

Mary Banks

Role: CONTACT

Facility Contacts

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Emmy H Okello

Role: primary

+256775522284

Other Identifiers

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2022-0714

Identifier Type: -

Identifier Source: org_study_id

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