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

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.

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:

• 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:

• 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.