Privately Rented Facility
Worcester, South Africa
NCT Number: NCT04151602
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.
Looking for future studies?
Notify Me15 year and older
All sexes
Observational
Worcester, South Africa
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants must be/have the following general inclusion criteria:
And for Aim 1:
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:
For Aim 3 Arm 2 patients must meet all general inclusion criteria and the following inclusion criteria:
And exclusion criteria:
General exclusion criteria under all aims and arms of the study include:
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)
The exposure of interest is current smoked illicit drug use, particularly methamphetamine and/or methaqualones
Time frame: At baseline
Percentage of persons with TB disease based on results from Xpert Ultra and sputum culture
Time frame: At baseline
Percentage of persons with incipient TB based on host RNA signature
Time frame: At baseline
Proportion of linked TB cases based on whole genome sequencing of the mycobacterium tuberculosis (Mtb) isolate and overlaying social epidemiological ties
Time frame: One hour
The amount of aerosolized Mtb exhaled in one hour in a specialized bio-aerosol capturing booth
Boston Medical Center
Other
Acronym: TOTAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06214910
Actinomycetales Infections, Bacterial Infections
Sweetwaters, KwaZulu-Natal, South Africa
View Trial DetailsNCT06739915
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Soweto, Gauteng, South Africa
View Trial DetailsNCT03896750
Actinomycetales Infections, Bacterial Infections
Miami, Florida, United States
View Trial DetailsNCT02906007
Actinomycetales Infections, Bacterial Infections
Port-au-Prince, Haiti
View Trial Details