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

Primary Purpose

Rheumatic Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
ADUNU program for delivery of RHD care services
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatic Heart Disease

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uganda Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ADUNU Participants

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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.
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.
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)
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)
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)
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).
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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
August 21, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Uganda Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05783375
Brief Title
Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda
Acronym
ADUNU
Official Title
Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2024 (Anticipated)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
January 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Uganda Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Heart Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
221 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADUNU Participants
Arm Type
Other
Arm Description
Individuals and healthcare providers residing and working in the involved Ugandan Districts.
Intervention Type
Other
Intervention Name(s)
ADUNU program for delivery of RHD care services
Intervention Description
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 Measure Information:
Title
Proportion of persons with RHD reached by the ADUNU program
Description
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).
Time Frame
5 year endpoint
Title
Proportion of persons with RHD enrolled in care, retained and adherent to treatment
Description
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.
Time Frame
12 months
Title
Proportion of persons with RHD enrolled in care, retained and adherent to treatment
Description
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.
Time Frame
24 months
Title
Adoption and implementation of the ADUNU program at the organization level surveys
Description
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)
Time Frame
Baseline
Title
Adoption and implementation of the ADUNU program at the organization level surveys
Description
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)
Time Frame
24 months
Title
Adoption and implementation of the ADUNU program at the provider level
Description
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)
Time Frame
6 months
Title
Adoption and implementation of the ADUNU program at the patient level interview
Description
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).
Time Frame
24 months
Title
Cost-analysis of the ADUNU program
Description
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.
Time Frame
3 year endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ndate Fall
Phone
15135171327
Email
ndate.fall@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Banks
Email
mary.Banks@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Z Beaton
Organizational Affiliation
Cincinnati Chidren's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmy H Okello
Organizational Affiliation
Uganda Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Watkins
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uganda Heart Institute
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmy H Okello
Phone
+256775522284
Email
emmyoks@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda

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