Menu
Recruiting NCT05783375

Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

No phase Interventional Rheumatic Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADUNU program for delivery of RHD care services.
Who it may be relevant to
Registry conditions: Rheumatic Heart Disease. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Other 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.

Primary outcome measures

  • Proportion of persons with RHD reached by the ADUNU program [Time frame: 5 year endpoint]
  • Proportion of persons with RHD enrolled in care, retained and adherent to treatment [Time frame: 3 months]
  • Proportion of persons with RHD enrolled in care, retained and adherent to treatment [Time frame: 24 months]
  • Adoption and implementation of the ADUNU program at the organization level surveys [Time frame: Baseline]
  • Adoption and implementation of the ADUNU program at the organization level surveys [Time frame: 24 months]
  • Adoption and implementation of the ADUNU program at the provider level [Time frame: 6 months]
  • Adoption and implementation of the ADUNU program at the patient level interview [Time frame: 24 months]
  • Cost-analysis of the ADUNU program [Time frame: 3 year endpoint]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Uganda · 1 center
  • Uganda Heart Institute — Kampala

Identifiers

NCT: NCT05783375 · 2022-0714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗