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

NCT05640648 | Completed Results

• 3 other identifiers: R01AI1048245R01AI1048242000023199
• Study Type: interventional
• Target: 10,477
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Completion of TB Evaluation

  The percentage of participants (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 Outcomes (5)

• TB Yield (Diagnosis and Treatment Initiation)

  60 days

• Initiation of TB Preventative Therapy

  60 days

• Number of Contacts Diagnosed With Active TB

  60 days

• Number of Contacts Initiating TB Preventative Therapy

  60 days

• TB Yield (All Contacts)

  60 days

Study Arms (2)

Standard Implementation Strategy Period

ACTIVE COMPARATOR

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

Enhanced Contact Investigation Intervention Period

EXPERIMENTAL

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

Interventions

User-Centered Implementation Strategy BEHAVIORAL

1. 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. 2. 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.

Also known as: Enhanced Contact Investigation Implementation Strategy

Enhanced Contact Investigation Intervention Period

Standard Implementation Strategy BEHAVIORAL

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.

Also known as: Usual Implementation Strategy

Standard Implementation Strategy Period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) Administrators of the health centre do not agree to participate in the study
• 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,
• 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.
• \) Being an adult or child reporting ≥12 cumulative hours with the TB patient inside an enclosed space within the previous 3 months,
• Lacking the capacity to consent to contact investigation,
• Currently taking treatment for active TB, and
• Not agreeing to participate in contact investigation.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Uganda Tuberculosis Implementation Research Consortium

Kampala, Uganda

Location

Related Publications (2)

• Katamba A, Gupta AJ, Turimumahoro P, Ochom E, Ggita JM, Nakasendwa S, Nanziri L, Musinguzi J, Hennein R, Sekadde M, Hanrahan C, Byaruhanga R, Yoeli E, Turyahabwe S, Cattamanchi A, Dowdy DW, Haberer JE, Armstrong-Hough M, Kiwanuka N, Davis JL. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: protocol for a stepped-wedge, cluster-randomised trial. BMC Public Health. 2023 Aug 17;23(1):1568. doi: 10.1186/s12889-023-16510-0.

  PMID: 37592314 DERIVED

• Katamba A, Gupta AJ, Turimumahoro P, Ochom E, Ggita JM, Nakasendwa S, Nanziri L, Musinguzi J, Hennein R, Sekadde M, Hanrahan C, Byaruhanga R, Yoeli E, Turyahabwe S, Cattamanchi A, Dowdy DW, Haberer JE, Armstrong-Hough M, Kiwanuka N, Davis JL. A user-centred implementation strategy for tuberculosis contact investigation in Uganda: Protocol for a stepped-wedge, cluster-randomised trial. Res Sq [Preprint]. 2023 Jul 6:rs.3.rs-3121275. doi: 10.21203/rs.3.rs-3121275/v1.

  PMID: 37461631 DERIVED

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. J. Lucian Davis
• Organization: Yale School of Public Health

lucian.davis@yale.edu

203-785-3665

Study Officials

• J. Lucian Davis, MD

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the assigned intervention is not feasible with the stepped-wedge cluster randomized implementation trial design, because interventions are implemented at the health-facility level and all health facilities receive the standard strategy followed by the enhanced, user-centered strategy. Community Health Workers will collect all data, and adjudicate all outcomes, except TB diagnoses and treatments initiated which will be collected from on-site National TB and Leprosy Programme registers. Where possible, the investigators and study staff, except for the statistician and data manager, will be blinded to any aggregated analyses of TB outcomes by study period.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 7, 2022
• Study Start: March 7, 2022
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After primary trial results are published
• Access Criteria: Upon request to the PI

Locations

UG (1)