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

Yale University

Status: Completed

Conditions: Tuberculosis; Tuberculosis, Pulmonary

Treatments: Behavioral: Standard Implementation Strategy; Behavioral: User-Centered Implementation Strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05640648

5R01AI104824 (U.S. NIH Grant/Contract)

R01AI104824

2000023199 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,477 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10,477 participants in 2 patient groups

Standard Implementation Strategy Period

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Implementation Strategy

Enhanced Contact Investigation Intervention Period

Experimental group

Description:

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.

Treatment:

Behavioral: User-Centered Implementation Strategy