Transmission of Tuberculosis Among Illicit Drug Use Linkages

NCT ID: NCT04151602

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 802 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2024-08-22

Brief 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. 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.

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

Conditions

Tuberculosis; Illicit Drug Use

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

PWUD with active TB

People who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with active TB disease

Smoked illicit drug use

Intervention Type: BEHAVIORAL

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

PWUD with no active TB

People who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with no active TB disease

Smoked illicit drug use

Intervention Type: BEHAVIORAL

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

non-PWUD with active TB

People who do not use meth/mandrax who have active TB disease

No interventions assigned to this group

Interventions

Smoked illicit drug use

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

(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)

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

Exclusion Criteria

1. No current pregnancy by urine pregnancy test

2. Not yet started on TB medication

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

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)

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Stellenbosch

OTHER

Sponsor Role: collaborator

Desmond Tutu HIV Foundation

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Jacobson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center/ BUMC

Locations

Privately Rented Facility

Worcester, , South Africa

Countries

South Africa

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AI147316-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-38910

Identifier Type: -

Identifier Source: org_study_id