- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04520113
Kharituwe TB Contact Tracing Study
October 4, 2023 updated by: Johns Hopkins Bloomberg School of Public Health
Innovative Contact Tracing Strategies for Detecting TB in Mobile Rural and Urban South African Populations
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
15000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Colleen F. Hanrahan, PhD
- Phone Number: 410-502-9289
- Email: chanrah1@jhmi.edu
Study Locations
-
-
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Johannesburg, South Africa
- Perinatal HIV Research Unit (PHRU)
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Soshanguve, South Africa
- Setshaba Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Tracing
Households of tuberculosis index patients receive "standard" household contact tracing during regular weekday business hours.
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Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
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Experimental: Holiday Tracing
Households of tuberculosis index patients in rural South Africa receive household contact tracing during holidays (Christmas and Easter).
|
Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
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Experimental: Evening / Weekend Tracing
Households of tuberculosis index patients in urban South Africa receive household contact tracing during evenings and weekends.
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Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness: ratio of secondary TB identified and started on treatment per index case in novel strategy arm compared to standard contact investigation arm
Time Frame: Duration of study (30 months)
|
The ratio of the number of secondary TB cases identified and started on treatment per index case in the novel strategy arm (off-peak screening in Soshanguve and holiday screening in Limpopo) compared to index cases receiving standard contact investigation.
|
Duration of study (30 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The TB prevalence ratio, comparing highly mobile to less mobile index patients
Time Frame: Duration of study (30 months)
|
The TB prevalence ratio, comparing highly mobile to less mobile individuals, measuring mobility on two scales (neighborhood/intra-urban and regional/intra-national).
For the analysis: amount of time spent in transit, truncating long excursions at 50km (one hour).
|
Duration of study (30 months)
|
TB strain relatedness using maximum likelihood transmission trees.
Time Frame: Duration of study (30 months)
|
TB natural history, epidemiological, and whole genome sequencing (WGS)-derived phylogenetic data will be integrated into a statistical modeling framework to draw probabilistic conclusions about the likelihood of transmission between persons.
"Transmitters" will be defined as individuals from whom at least one secondary case most likely originated.
|
Duration of study (30 months)
|
Relative acceptability of each novel strategy compared to standard contact investigation
Time Frame: Duration of study (30 months)
|
Relative acceptability of each novel strategy, compared against routine contact investigation.
Acceptability of the intervention will be measured among index cases and contacts using a short questionnaire given to a randomly selected participant at a randomly selected 15% of the households visited.
The interview will cover acceptability of the visit timing, notification, visit activities (TB screening, HIV testing) and study team interaction among others.
|
Duration of study (30 months)
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Feasibility of each strategy: proportion of potentially eligible index cases for whom a household visit was conducted
Time Frame: Duration of study (30 months(
|
Feasibility of each strategy as the proportion of potentially eligible index cases for whom a household visit was conducted.
All reasons why visits were unable to be conducted will be recorded (e.g. could not find household, no one ever home, visit not conducted during expected off-peak period).
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Duration of study (30 months(
|
Relative fidelity of each novel strategy compared to standard contact investigation
Time Frame: Duration of study (30 months)
|
Relative fidelity of each novel strategy using a process checklist for each index case and household, including whether the household visit was offered and accepted, whether the visit was attempted, whether the visit was successful (i.e., enrolled at least one contact), whether symptom screening and sputum collection were completed and whether newly identified TB cases were notified and referred for treatment.
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Duration of study (30 months)
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Sustainability of each novel strategy relative to standard contact tracing
Time Frame: Duration of study (30 months)
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Sustainability of each novel strategy by reporting the primary outcome and fidelity measures according to six-month time period over the course of the study.
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Duration of study (30 months)
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Incremental cost-effectiveness ratio for each novel strategy relative to standard contact tracing
Time Frame: Duration of study (30 months)
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Defined as (cost of contact tracing strategy 2 - cost of strategy 1)/(effectiveness of strategy 2 - effectiveness of strategy 1), where effectiveness is modeled as the number of disability-adjusted life years (DALYs) averted by the intervention.
The primary cost-effectiveness measures will be the incremental cost per DALY averted using novel strategies (holiday and off-hours contact tracing) compared to routine contact tracing in each setting separately.
|
Duration of study (30 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David W. Dowdy, MD, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
August 7, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 4, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AI147681 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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