Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

NCT05783375 | Recruiting

• 1 other identifier: 2022-0714
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (8)

• 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.

  12 months

• 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

Study Arms (1)

ADUNU Participants

OTHER

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

Other: ADUNU program for delivery of RHD care services

Interventions

ADUNU program for delivery of RHD care services 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.

ADUNU Participants

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Uganda Heart Institute: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda, Uganda

RECRUITING

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Z Beaton

  Cincinnati Chidren's hospital

  PRINCIPAL INVESTIGATOR

• Emmy H Okello

  Uganda Heart Institute

  PRINCIPAL INVESTIGATOR

• David Watkins

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ndate Fall

CONTACT

15135171327; ndate.fall@cchmc.org

Mary Banks

CONTACT

mary.Banks@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 24, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

UG (1)