Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04151602
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT04151602
Study Brief:
Protocol Section:
NCT04151602