Kharituwe TB Contact Tracing Study

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Tuberculosis; Hiv

Treatments: Behavioral: Household contact tracing

Study type: Interventional

Funder types: Other

Identifiers

NCT04520113

R01AI147681

IRB00011124 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations

Full description

The investigators propose a randomized trial of two novel TB case-finding interventions among household members of patients diagnosed with active TB: holiday-based screening in a rural South African province (Limpopo) and off-peak (weekend/evening) screening in an urban settlement into which many residents of Limpopo migrate for work. The investigators will enroll index cases of TB plus their household contacts in each setting and randomize them to novel versus standard contact investigation. In Specific Aim 1, investigators will use whole genome sequencing of all cases, overlaying transmission trees with data on human movement, to evaluate associations between mobility and TB transmission in this population. In Specific Aim 2, investigators will employ a multidisciplinary approach to compare novel versus standard contact investigation in each setting along the following dimensions: (a) effectiveness (number of secondary TB cases diagnosed and starting treatment); (b) implementation (reach, fidelity, and maintenance of contact investigation outside of business hours); (c) cost-effectiveness (cost per disability-adjusted life year) and budget impact; and (d) projected population-level impact on TB incidence. Successful completion of these aims will have long-term impact by characterizing the role of mobility in fueling TB epidemics and testing two tailored approaches to improve TB control in highly mobile populations - an underserved group that is increasingly recognized as playing a major role in global TB transmission.

Enrollment: 10,579 patients

Sex: All

Ages: Under 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

TB index cases:

Inclusion criteria:

• Age 0-99 years (Including those recently deceased)
• Diagnosed with pulmonary TB at a study hospital or clinic (microbiological and/or chest x-ray diagnosis)

Exclusion criteria:

• Unwilling/unable to provide informed consent (including next of kin, for those recently deceased)
• Plan not to pursue TB treatment within the study district
• Unwilling/unable to comply with study procedures

Contacts:

Inclusion criteria:

• Age 0-99 years
• Currently resides with or visiting eligible TB index case

Exclusion Criteria:

• Unwilling/unable to provide informed consent
• Unwilling/unable to comply with study procedures

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,579 participants in 3 patient groups

Standard Tracing

Active Comparator group

Description:

Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.

Treatment:

Behavioral: Household contact tracing

Holiday Tracing

Experimental group

Description:

Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).

Treatment:

Behavioral: Household contact tracing

Evening / Weekend Tracing

Experimental group

Description:

Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.

Treatment:

Behavioral: Household contact tracing