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

Not Applicable

Completed

• Conditions: Tuberculosis; Tuberculosis, Pulmonary

• Registration Number: NCT05640648
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2022-03-07
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-07
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26
• Results First Submitted: 2024-10-25
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Results First Posted: 2025-03-30
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10477

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Completion of TB Evaluation	60 days	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

Secondary Outcome Measures

Name	Time	Method
TB Yield (Diagnosis and Treatment Initiation)	60 days	The difference between study periods in percentage of contacts diagnosed with active TB and initiated on treatment within 60 days of the TB patient's treatment initiation
Number of Contacts Initiating TB Preventative Therapy	60 days	The difference between study periods in counts of the number of contacts initiating TPT
Initiation of TB Preventative Therapy	60 days	The difference between study periods in percentage of contacts initiating TB preventative therapy (TPT) within 60 days of the TB patient's treatment initiation
Number of Contacts Diagnosed With Active TB	60 days	The difference between study periods in counts of the number of contacts diagnosed with active TB
TB Yield (All Contacts)	60 days	The difference between study periods in percentage of all TB cases among contacts

Trial Locations

Locations (1)

Uganda Tuberculosis Implementation Research Consortium; 🇺🇬 Kampala, Uganda