Clinical trial NCT04520113: Kharituwe TB Contact Tracing Study
Official title: Innovative Contact Tracing Strategies for Detecting TB in Mobile Rural and Urban South African Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Hiv
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Perinatal HIV Research Unit of the University of the Witswatersrand
name: Setshaba Research Centre
name: The National Institute for Communicable Diseases
First posted: 2020-08-20
Enrollment: 10579
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm
timeFrame: Up to 35 months
Secondary outcomes:
measure: The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients
timeFrame: Duration of study (30 months)
measure: TB Strain Relatedness Using Maximum Likelihood Transmission Trees.
timeFrame: Duration of study (30 months)
measure: Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation
timeFrame: Duration of study (30 months)
measure: Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted
timeFrame: Duration of study (30 months(
measure: Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation
timeFrame: Duration of study (30 months)
measure: Sustainability of Each Novel Strategy Relative to Standard Contact Tracing
timeFrame: Duration of study (30 months)
measure: Incremental Cost-effectiveness Ratio for Each Novel Strategy Relative to Standard Contact Tracing
timeFrame: Duration of study (30 months)
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: David W. Dowdy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: