Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human-centered Design and Communities of Practice to Improve Delivery of Home-based Tuberculosis Contact Investigation in Uganda

Conditions
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Tuberculosis, Tuberculosis, Pulmonary

Intervention / Treatment
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* Behavioral: User-Centered Implementation Strategy
* Behavioral: Standard Implementation Strategy


Participation Criteria
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Eligibility Criteria
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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 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): Being an adult or child recorded as a new TB case in the on-site National TB and Leprosy Programme TB treatment register, and Residing ≤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, and 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: Lacking the capacity to consent to contact investigation, Currently taking treatment for active TB, and Not agreeing to participate in contact investigation.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Implementation Strategy Period<br>During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person. | Behavioral: Standard Implementation Strategy<br>* Once an eligible TB patient agrees to participate, CHWs will visit the patient to assess the eligibility of close contacts to participate. For eligible contacts who agree to participate, the CHW will perform TB symptom screening and arrange subsequent microbiologic, clinical, and/or radiographic evaluation. Those screening TB symptom-positive will be asked to expectorate a sputum sample, unless under age 5. If under age 5 or unable to produce sputum, contacts will be referred to the health centre for evaluation. A CHW will transport sputum samples to the health-centre laboratory for microbiologic evaluation and later report the test results back to the contact. During the standard implementation strategy period, CHWs at all sites will receive the standard TB program training on TB contact investigation and supportive supervision from the on-site National TB Program focal person.<br>* Other names: Usual Implementation Strategy;|
| Experimental: Enhanced Contact Investigation Intervention Period<br>The enhanced contact investigation strategy includes 4 implementation facilitation tools and 3 continuous quality improvement techniques and will be delivered as a branded package named for an inspirational Luganda phrase that is translated as We are together with you. Implementation facilitation tools include 1) a TB education pamphlet, 2) a contact identification algorithm, 3) an instructional video on sputum collection, and 4) community health riders who transport clients, community health workers, and sputum samples by motorcycle. The continuous quality improvement techniques delivered as the community of practice package include 1) community of practice meetings, 2) audit and feedback reports and 3) a group chat application. | Behavioral: User-Centered Implementation Strategy<br>* 4 participant-facing components: 1a) TB education pamphlet helps index TB persons disclose the need for household screening to contacts. 1b) Contact identification algorithm helps CHWs and index TB persons accurately enumerate contacts. 1c) Sputum collection video instructs contacts to expectorate good-quality sputum. 1d) Community Health Riders transport CHWs, index persons with TB, and contacts by motorcycle taxi, and collect and transport sputum. 3 community health-worker-facing components: a) Weekly CHW meetings create communities of practice (CoP), professionals organized for peer support and systematic learning. Meetings involve problem solving, review of audit and feedback reports, and didactics on TB care, among other activities. 2b) Audit and feedback reports on contact investigation performance indicators weekly (individual CHW) and monthly (health facility). 2c) A group-chat application facilitates peer support among CHWs.<br>* Other names: Enhanced Contact Investigation Implementation Strategy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of TB Evaluation | The difference in proportions of close contacts who are experiencing TB symptoms who complete TB evaluation within 60 days of the TB patient's treatment initiation date | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TB Yield (symptomatic contacts) | The difference between study periods in proportions of contacts diagnosed with active TB and initiated on treatment within 60 days of the TB patient's treatment initiation | 60 days | 
| Initiation of TB Preventative Therapy | The difference between study periods in proportions of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation | 60 days | 
| Number of contacts diagnosed with active TB | The difference between study periods in counts of the number of contacts diagnosed with active TB | 60 days | 
| Number of contacts initiating TB Preventative Therapy | The difference between study periods in counts of the number of contacts initiating TPT | 60 days | 
| TB Yield (all contacts) | The difference between study periods in proportions of all TB cases among contacts | 60 days |