Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda (ADUNU)

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Heart Disease
• Intervention / Treatment: Other: ADUNU program for delivery of RHD care services

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.

• Study Type: Interventional
• Enrollment (Estimated): 221
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ndate Fall; Phone Number: 15135171327; Email: ndate.fall@cchmc.org
• Study Contact Backup: Name: Mary Banks; Email: mary.Banks@cchmc.org

Study Locations

• Uganda
  • Uganda
    • Kampala, Uganda, Uganda
      • Recruiting
      • Uganda Heart Institute
      • Contact: Emmy H Okello; Phone Number: +256775522284; Email: emmyoks@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Individuals over the age of 5 year old residing in Kitgum and Amuru districts in Uganda All providers at HCIIIs and HCIVs located in Kitgum and Amuru

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ADUNU Participants; Individuals and healthcare providers residing and working in the involved Ugandan Districts.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of persons with RHD reached by the ADUNU program	This objective will involve only secondary analysis of de-identified data collected by districts using routine MOH data collection procedures supplemented by some routine program data during the Ministry's rollout of the ADUNU Programme Package. The number of individuals screened and screening positivity rates will be extracted from screening logs implemented and maintained by DHOs and assessed by modality (school fairs, health days, passive health center screening, and active outreach to family members of RHD diagnosed).	5 year endpoint
Proportion of persons with RHD enrolled in care, retained and adherent to treatment	Secondary analysis of data from the districts RHD registry will be used to assess the proportion of registrants enrolled, retained and adherent to secondary prophylaxis.	24 months
Adoption and implementation of the ADUNU program at the organization level surveys	Brief surveys will be filled out by providers who are acting as administrators of their health centre and will include questions on a range of logistic (e.g., availability of commodities and stockouts, basic infrastructure reliability) and organizational readiness topics (e.g., staffing levels and turnover, organization of patient scheduling, district support visits)	Baseline
Adoption and implementation of the ADUNU program at the organization level surveys	Brief surveys will be filled out by providers who are acting as administrators of their health centre and will include questions on a range of logistic (e.g., availability of commodities and stockouts, basic infrastructure reliability) and organizational readiness topics (e.g., staffing levels and turnover, organization of patient scheduling, district support visits)	24 months
Adoption and implementation of the ADUNU program at the provider level	Two types of data collection activities from frontline providers will be used to understand individual provider-level adoption and maintenance over time: provider surveys and in-depth interviews of providers. A standardized survey instrument on Adoption and a standardized checklist on implementation fidelity that will be completed by the research staff via direct observation. Research staff will use a standardized checklist that will be developed from the core elements of RHD testing (e.g., ultrasound technique, saving of images) and secondary prevention (e.g., injection technique, adequate post-injection monitoring for anaphylaxis)	6 months
Adoption and implementation of the ADUNU program at the patient level interview	We will conduct a limited number of interviews of registry patients in each district stratified by adherence outcomes as well as age group (adult vs children).	24 months
Cost-analysis of the ADUNU program	To estimate program costs, we will use the standardized data collection instruments. Our instruments will measure fixed and capital costs, as well as variable or recurrent costs. Ingredients-based costing will be used for drugs and consumables, personnel costs, and equipment costs, whereas gross costing will be used for "indirect" costs such as facility rents and utilities and maintenance. Relevant data for ingredients-based costing include study data on participant healthcare utilization and price lists of drugs, consumables, and equipment. DHO budget sheets for health facilities and overall health service utilization will be used for gross costing. Both financial costs and economic costs will be measured. We will also estimate of out-of-pocket costs borne by registrants, which will allow us to estimate costs from the patient/household perspective.	3 year endpoint
Proportion of persons with RHD enrolled in care, retained and adherent to treatment	Secondary analysis of data from the districts RHD registry will be used to assess the proportion of registrants enrolled, retained and adherent to secondary prophylaxis.	3 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Uganda Heart Institute
• Investigators: Principal Investigator: Emmy H Okello, Uganda Heart Institute; Principal Investigator: David Watkins, University of Washington; Principal Investigator: Andrea Z Beaton, Cincinnati Chidren's hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Rheumatic Fever; Rheumatic Heart Disease
• Other Study ID Numbers: 2022-0714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No