Transmission of Tuberculosis Among Illicit Drug Use Linkages

Completed

• Conditions: Illicit Drug Use; Tuberculosis
• Interventions: Behavioral: Smoked illicit drug use

• Registration Number: NCT04151602
• Lead Sponsor: Boston Medical Center

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

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2021-04-22
• Primary Completion: 2023-10-26
• Study Completion: 2024-08-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PWUD with active TB	Smoked illicit drug use	People who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with active TB disease
PWUD with no active TB	Smoked illicit drug use	People who use smoked illicit drugs (methamphetamine and/or methaqualone (mandrax)) with no active TB disease

Primary Outcome Measures

Name	Time	Method
TB disease prevalence	At baseline	Percentage of persons with TB disease based on results from Xpert Ultra and sputum culture
Quantity of aerosolized Mtb in exhaled breath: amount of aerosolized Mtb exhaled in one hour	One hour	The amount of aerosolized Mtb exhaled in one hour in a specialized bio-aerosol capturing booth
Incipient TB prevalence	At baseline	Percentage of persons with incipient TB based on host RNA signature
Proportion of active TB cases resulting from recent transmission within this network of PWUD	At baseline	Proportion of linked TB cases based on whole genome sequencing of the mycobacterium tuberculosis (Mtb) isolate and overlaying social epidemiological ties

Trial Locations

Locations (1)

Privately Rented Facility; 🇿🇦 Worcester, South Africa