Clinical trial NCT05640648: Human-centered Design and Communities of Practice to Improve Home-based Tuberculosis Contact Investigation in Uganda
Official title: Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Tuberculosis, Pulmonary
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-12-07
Enrollment: 10477
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will conduct a stepped-wedge, cluster-randomized implementation trial with nested mixed-methods evaluations of fidelity and context and health economic analyses. The stepped-wedge trial will include six transition steps in a complete (also known as closed) design, providing a 1:1 ratio of time periods allocated to the pre-implementation standard strategy and the post-implementation user-centered strategy.
Primary purpose: SCREENING

Brief 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.

Detailed description: The trial has 3 major aims: (1) to compare the implementation, effectiveness, and public health impact of TB contact investigation delivered via an enhanced, "user-centered" implementation strategy versus a standard implementation strategy in a stepped-wedge, cluster-randomized implementation trial; (2) to identify processes and contextual factors that influence the implementation, effectiveness, and public health impact of the enhanced delivery strategy for TB contact investigation; and (3) to compare the costs and epidemiological impact of the enhanced and standard implementation strategies for TB contact investigation. The enhanced, user-centered strategy will employ two major components: a) a branded, participant-centered strategy consisting of implementation facilitation tools previously developed using human-centered design; and b) Communities of Practice, a community-health worker-centered, continuous quality improvement strategy. The goal is to improve the delivery of standard TB contact investigation following Uganda National TB \& Leprosy Programme guidelines. The investigators hypothesize that the enhanced, user-centered strategy will result in a greater proportion of close contacts completing TB evaluation than the standard strategy. They further hypothesize that successful implementation will be deemed feasible, acceptable, and appropriate by patients and CHWs and that it will increase self-efficacy and perceived social support among CHWs. Finally, the investigators hypothesize that models evaluating the impact of the user-centered strategy when delivered nationwide will find it cost-effective and able to reduce national TB incidence over a 10-year horizon.

Eligibility criteria: Health centre inclusion criteria:

1. Reporting ≥12 index TB cases per month to the national TB program,
2. Located outside the borders of but ≤180 km from Kampala District

Health centre exclusion criteria:

1) Administrators of the health centre do not agree to participate in the study

Individual inclusion criteria for index persons with TB (also known as index TB patients or TB cases):

1. Being an adult or child recorded as a new TB case in the on-site National TB and Leprosy Programme TB treatment register, and
2. Residing ≤40 km from the enrolling health centre,

Individual exclusion criteria for index persons with TB :

1. Lacking the capacity to consent to contact investigation,
2. Lacking close contacts,
3. Having possible or confirmed drug-resistant TB,
4. Previously received TB contact investigation within the last 2 months, and
5. Not 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:

1. Lacking the capacity to consent to contact investigation,
2. Currently taking treatment for active TB, and
3. Not agreeing to participate in contact investigation.

Primary outcomes:
measure: Completion of TB Evaluation
timeFrame: 60 days
Secondary outcomes:
measure: TB Yield (Diagnosis and Treatment Initiation)
timeFrame: 60 days
measure: Initiation of TB Preventative Therapy
timeFrame: 60 days
measure: Number of Contacts Diagnosed With Active TB
timeFrame: 60 days
measure: Number of Contacts Initiating TB Preventative Therapy
timeFrame: 60 days
measure: TB Yield (All Contacts)
timeFrame: 60 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Uganda Tuberculosis Implementation Research Consortium
Study officials:
affiliation: Yale School of Public Health
name: J. Lucian Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: