NCT04151602Completed
Transmission of Tuberculosis Among Illicit Drug Use Linkages
Source: ClinicalTrials.gov · Last updated 3 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 802 (actual)
- First submitted
- 1 Nov 2019
- Start date
- 22 Apr 2021
- Primary completion date
- 26 Oct 2023
- Lead sponsor
- Boston Medical Center
- Diseases
- Tuberculosis
- NCT number
- NCT04151602
What you commit to
- Study type: Observational
- Participants enrolled: 802
- From 22 Apr 2021 to the primary completion date, 26 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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)
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Privately Rented Facility Coordinator of this site? Confirm its status | Worcester | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.