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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Tuberculosis, Pulmonary
• Intervention / Treatment: Behavioral: Standard Implementation Strategy; Behavioral: User-Centered Implementation Strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 10477
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Uganda Tuberculosis Implementation Research Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Implementation Strategy Period; 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; 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.; Other Names: Usual Implementation Strategy
Experimental: Enhanced Contact Investigation Intervention Period; 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; 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.; Other Names: Enhanced Contact Investigation Implementation Strategy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: J. Lucian Davis, MD, Yale School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: R01AI104824 (U.S. NIH Grant/Contract); 5R01AI104824 (U.S. NIH Grant/Contract); 2000023199 (Other Identifier: Yale IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication upon request
• IPD Sharing Time Frame: After primary trial results are published
• IPD Sharing Access Criteria: Upon request to the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No