Clinical trial NCT05783375: Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda
Official title: Accelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatic Heart Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Uganda Heart Institute
First posted: 2023-03-24
Enrollment: 221
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Proportion of persons with RHD reached by the ADUNU program
timeFrame: 5 year endpoint
measure: Proportion of persons with RHD enrolled in care, retained and adherent to treatment
timeFrame: 12 months
measure: Proportion of persons with RHD enrolled in care, retained and adherent to treatment
timeFrame: 24 months
measure: Adoption and implementation of the ADUNU program at the organization level surveys
timeFrame: Baseline
measure: Adoption and implementation of the ADUNU program at the organization level surveys
timeFrame: 24 months
measure: Adoption and implementation of the ADUNU program at the provider level
timeFrame: 6 months
measure: Adoption and implementation of the ADUNU program at the patient level interview
timeFrame: 24 months
measure: Cost-analysis of the ADUNU program
timeFrame: 3 year endpoint
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Uganda Heart Institute
Study officials:
affiliation: Cincinnati Chidren's hospital
name: Andrea Z Beaton
role: PRINCIPAL_INVESTIGATOR
affiliation: Uganda Heart Institute
name: Emmy H Okello
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: David Watkins
role: PRINCIPAL_INVESTIGATOR
References: