Kharituwe TB Contact Tracing Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10579 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Tuberculosis Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

The principal investigators are blinded as to the assignment of treatment to participants

Study Groups

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Standard Tracing

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

Group Type ACTIVE_COMPARATOR

Household contact tracing

Intervention Type BEHAVIORAL

Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Holiday Tracing

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

Group Type EXPERIMENTAL

Household contact tracing

Intervention Type BEHAVIORAL

Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Evening / Weekend Tracing

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

Group Type EXPERIMENTAL

Household contact tracing

Intervention Type BEHAVIORAL

Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Interventions

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Household contact tracing

Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

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

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:

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

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes