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Enrolling By Invitation
NCT05640648
Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda
Conditions: Tuberculosis, Tuberculosis, Pulmonary
Sex: All
Healthy volunteers: 1
Phase: NA
Enrollment: 14000
Sponsor: Yale University
Location: Uganda
Summary
In a previous randomized control trial, the investigators identified gaps in the implementation of tuberculosis (TB) contact investigation at multiple levels of the service delivery cascade.
Drawing on prior experiences, the investigators have recently developed a novel strategy to enhance the implementation of routine contact investigation procedures.
This user-centered implementation strategy was created through serial prototyping guided by human-centered design (HCD) and employs communities of practice (CoP) as an adjunctive adaptation and sustainment strategy.
The investigators are now conducting a stepped-wedge, cluster-randomized implementation trial in 12 study sites in Uganda to determine if the resulting user-centered implementation strategy enhances the delivery of TB contact investigation and other implementation outcomes, and also improves health outcomes.
Eligibility Criteria
Health centre inclusion criteria:Reporting ≥12 index TB cases per month to the national TB program,Located outside the borders of but ≤180 km from Kampala DistrictHealth centre exclusion criteria:1) Administrators of the health centre do not agree to participate in the studyIndividual inclusion criteria for index persons with TB (also known as index TB patients or TB cases):Being an adult or child recorded as a new TB case in the on-site National TB and Leprosy Programme TB treatment register, andResiding ≤40 km from the enrolling health centre,Individual exclusion criteria for index persons with TB :Lacking the capacity to consent to contact investigation,Lacking close contacts,Having possible or confirmed drug-resistant TB,Previously received TB contact investigation within the last 2 months, andNot agreeing to refer close contacts for contact investigation.Inclusion criteria for close contacts:1) Being an adult or child reporting ≥12 cumulative hours with the TB patient inside an enclosed space within the previous 3 months,Exclusion criteria for close contacts:Lacking the capacity to consent to contact investigation,Currently taking treatment for active TB, andNot agreeing to participate in contact investigation.
Source: ClinicalTrials.gov (NCT05640648). StuddyBuddy aggregates publicly available trial information.