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TuberculosisTOTALNCT04151602

Transmission of Tuberculosis Among Illicit Drug Use Linkages

An observational study of Tuberculosis and Illicit Drug Use, run by Boston Medical Center at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tuberculosis (TB) is the leading infectious disease killer globally and leading cause of death in persons with HIV. The most effective way to reduce TB incidence and mortality is to interrupt transmission. This requires finding and treating individuals with TB disease early, including those with subclinical disease. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Tuberculosis, Illicit Drug Use
What is being tested?
Smoked illicit drug use
How many people
802 participants
Where
1 siteSouth Africa
Study dates
22 Apr 2021to 22 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Participants must be/have the following general inclusion criteria:

  1. at least 15 years old
  2. resident of the study community
  3. intact mental status at enrollment (i.e., no acute intoxication)
  4. provide written, informed consent to participate in the study if ≥18 years or written assent and parental consent if <18 years.
  5. agree to comply with all study requirements, including provision of contact information and study appointments attendance

And for Aim 1:

  1. self-reported meth or Mandrax use in the past month
  2. urine drug screen positive for meth and/or Mandrax
  3. 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:

  1. No current pregnancy by urine pregnancy test
  2. Not yet started on TB medication

For Aim 3 Arm 2 patients must meet all general inclusion criteria and the following inclusion criteria:

  1. Attend the Worcester Community Day Clinic, the Empilisweni Clinic, or any other clinic and live in the general Worcester area
  2. Have newly diagnosed TB

And exclusion criteria:

  1. No self-reported drug use or evidence of drug use by urine test
  2. No current pregnancy by urine pregnancy test
  3. Not yet started TB medication

General exclusion criteria under all aims and arms of the study include:

  1. Current drug or alcohol intoxication
  2. Mental incapacitation to providing informed consent
  3. 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)

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Privately Rented Facility

    Worcester

Other trials in South Africa

About this study

Tuberculosis (TB) is the leading infectious disease killer globally and leading cause of death in persons with HIV. The most effective way to reduce TB incidence and mortality is to interrupt transmission. This requires finding and treating individuals with TB disease early, including those with subclinical disease. Molecular epidemiologic studies and mathematical models have shown that the primary approach to case finding-household contact tracing-identifies only 8-19% of transmissions in high TB and TB/HIV burden settings. Thus there is a clear need to identify new groups and settings where TB transmission occurs. Spatial clustering of individuals with higher rates of progression from infection to disease, such as those with HIV and malnourishment, can also form transmission hotspots. Illicit drug (i.e., methamphetamines, crack/cocaine, opiates) users have higher TB infection prevalence and disease incidence compared to non-users, likely due to significant within-group transmission and/or clustered vulnerability. Increased transmission among people who use illicit drugs (PWUD) could result from creation of more efficient TB transmitters, increased close contact among transmitters, increased rates of primary progression from infection to disease among contacts, or a combination. Interrogation of illicit drug user networks for TB transmission, therefore, holds great potential as a target for early case identification and linkage to treatment, with potential benefit for halting transmission to the broader population.

Read the 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

Being tested
Smoked illicit drug use
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smoked illicit drug useBehavioural

    The exposure of interest is current smoked illicit drug use, particularly methamphetamine and/or methaqualones

Study groups in NCT04151602
Study groupRoleWhat they receive
PWUD with active TBPeople who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with active TB disease
Receives: Behavioral: Smoked illicit drug use
PWUD with no active TBPeople who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with no active TB disease
Receives: Behavioral: Smoked illicit drug use
non-PWUD with active TBPeople who do not use meth/mandrax who have active TB disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TB disease prevalence

    Percentage of persons with TB disease based on results from Xpert Ultra and sputum culture

    Measured: At baseline

  2. Incipient TB prevalence

    Percentage of persons with incipient TB based on host RNA signature

    Measured: At baseline

  3. Proportion of active TB cases resulting from recent transmission within this network of PWUD

    Proportion of linked TB cases based on whole genome sequencing of the mycobacterium tuberculosis (Mtb) isolate and overlaying social epidemiological ties

    Measured: At baseline

  4. Quantity of aerosolized Mtb in exhaled breath: amount of aerosolized Mtb exhaled in one hour

    The amount of aerosolized Mtb exhaled in one hour in a specialized bio-aerosol capturing booth

    Measured: One hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start22 Apr 2021
  3. Primary completion26 Oct 2023
  4. Study completion22 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151602
Sponsor's protocol ID
H-38910
Other IDs
1R01AI147316-01
Acronym
TOTAL
Status last verified
Apr 2025
First submitted
1 Nov 2019
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tuberculosis and Illicit Drug Use, run by Boston Medical Center at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TB disease prevalence (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04151602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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