- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151602
Transmission of Tuberculosis Among Illicit Drug Use Linkages (TOTAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cross-sectional, observational study design using respondent driven sampling (RDS) will be used for this research study.
In Aim 1, individuals will be recruited who currently use meth and/or Mandrax to assess TB exposure, incipient TB prevalence, and TB disease prevalence in the network. RDS will be used to seek out 750 meth/Mandrax users. Initial seeds (N=4) will be individuals from the investigator's current R01, the Tuberculosis treatment outcomes and alcohol use study (TRUST) cohort who have had active pulmonary TB disease in the prior 1-2 years and report current meth/Mandrax use.
For Aim 2, individuals from Aim 1 identified to have possible TB disease will be screened and enrolled to estimate the proportion that reflect recent transmission via genotyping and social epidemiologic links.
In Aim 3, the investigators will examine physiologic factors that may make PWUD more efficient TB transmitters. 50 PWUD participants from Aim 2 will be recruited who have active, untreated pulmonary TB and 50 individuals with active, untreated pulmonary TB who do not use meth/Mandrax, matched on age and gender will be recruited
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Worcester, South Africa
- Privately Rented Facility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
750 PWUD in the Western Cape, South Africa will be enrolled into Aim 1. An anticipated 45-75 will have active TB disease and enrolled into Aim 2 and Aim 3 Arm 1 of the study.
50 people who do not smoke illicit drugs with active TB disease will be enrolled into Aim 3 Arm 2.
Description
Participants must be/have the following general inclusion criteria:
- at least 15 years old
- resident of the study community
- intact mental status at enrollment (i.e., no acute intoxication)
- provide written, informed consent to participate in the study if ≥18 years or written assent and parental consent if <18 years.
- agree to comply with all study requirements, including provision of contact information and study appointments attendance
And for Aim 1:
- self-reported meth or Mandrax use in the past month
- urine drug screen positive for meth and/or Mandrax
- all participants other than the seeds must also have evidence that they have been recruited by a peer (the coupon)
For Aim 2 participants must meet all general inclusion criteria and the inclusion criteria from Aim 1 (meth/Mandrax use) and:
(1) Have evidence of active TB disease on Xpert Ultra from their Aim 1 visit testing or report a recent TB diagnosis (within the past month)
For Aim 3 Arm 1 participants must meet all general inclusion criteria and the criteria under Aim 1 and Aim 2 (active illicit drug use and active TB)
And exclusion criteria:
- No current pregnancy by urine pregnancy test
- Not yet started on TB medication
For Aim 3 Arm 2 patients must meet all general inclusion criteria and the following inclusion criteria:
- Attend the Worcester Community Day Clinic, the Empilisweni Clinic, or any other clinic and live in the general Worcester area
- Have newly diagnosed TB
And exclusion criteria:
- No self-reported drug use or evidence of drug use by urine test
- No current pregnancy by urine pregnancy test
- Not yet started TB medication
General exclusion criteria under all aims and arms of the study include:
- Current drug or alcohol intoxication
- Mental incapacitation to providing informed consent
- Not currently or previously enrolled in any prophylactic TB therapy studies
Participants may also be excluded from the study under discretion of the Principal Investigator if the PI believes participation in the study may prove harmful to the participant or the research staff.
Participants will be enrolled from the main cohort (n=750) (Aim 1) into the additional cohorts under Aims 2 and Aim 3 Arm 1. Aim 3 Arm 2 will be recruited external to the main cohort (Aim 1)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PWUD with active TB
People who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with active TB disease
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The exposure of interest is current smoked illicit drug use, particularly methamphetamine and/or methaqualones
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PWUD with no active TB
People who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with no active TB disease
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The exposure of interest is current smoked illicit drug use, particularly methamphetamine and/or methaqualones
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non-PWUD with active TB
People who do not use meth/mandrax who have active TB disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TB disease prevalence
Time Frame: At baseline
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Percentage of persons with TB disease based on results from Xpert Ultra and sputum culture
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At baseline
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Incipient TB prevalence
Time Frame: At baseline
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Percentage of persons with incipient TB based on host RNA signature
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At baseline
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Proportion of active TB cases resulting from recent transmission within this network of PWUD
Time Frame: Study duration - 3 years
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Proportion of linked TB cases based on whole genome sequencing of the mycobacterium tuberculosis (Mtb) isolate and overlaying social epidemiological ties
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Study duration - 3 years
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Quantity of aerosolized Mtb in exhaled breath: amount of aerosolized Mtb exhaled in one hour
Time Frame: One hour
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The amount of aerosolized Mtb exhaled in one hour in a specialized bio-aerosol capturing booth
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One hour
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Jacobson, MD MPH, Boston Medical Center/ BUMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-38910
- 1R01AI147316-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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