Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Control Trial of Sputum Induction, and New and Emerging Technologies in a High HIV Prevalence Primary Care Setting
Brief Summary: This study will investigate the benefit of using Sputum induction for TB diagnosis in a primary care clinic for adult TB suspects that are either unable to produce a sputum sample (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (WHO standard for frontline TB diagnosis). The investigators hypothesize that acquiring an induced sputum sample for smear microscopy and liquid TB culture will decrease time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce TB patients in a primary care clinic in a resource-limited high TB HIV prevalent setting.


Options:
A: Inclusion Criteria (Individuals must meet all of the following inclusion criteria in order to be eligible to participate):

* Informed consent
* Suspected active tuberculosis
* Willingness and ability to comply with study procedures
* Any one or more of the following:

  * Current cough
  * Fever at any time within the preceding 4 weeks
  * Night sweats at any time within the preceding 4 weeks
  * Weight loss within the preceding 4 weeks
* HIV-positive based on any one or more of the following:

  * written results of a positive HIV antibody test, and/or
  * written results of a positive HIV viral load, and/or
  * documentation in the medical record of positive HIV status by a treating clinician.

Exclusion Criteria (Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation):

* Multidrug tuberculosis treatment for greater than two days within the previous 60 days
* Unwillingness or inability to provide a urine sample
* Known chronic pulmonary condition, e.g. asthma, chronic obstructive pulmonary disease, emphysema
* Respiratory distress, defined as respiratory rate of \>30 or oxygen saturation \<90%
* Any specific condition that in the judgment of the investigator precludes participation because it could affect a subject's safety.
B: Inclusion Criteria:

1. Able and willing to give informed consent
2. Ambulant patient presenting to TB clinic

   IF HIV negative requires 2 or more of the following:
   * Cough ≥ 2 weeks
   * loss of weight
   * persistent fever ≥ 2 weeks and/or
   * a single recorded temp \> 38°C
   * night sweats
   * generalized fatigue
   * hemoptysis or
   * chest pain

   OR if HIV positive - any one of the following:
   * current cough
   * night sweats
   * fever
   * loss of weight
3. Patient 18 years or above

Exclusion Criteria:

1. Inability to provide informed consent (e.g. mentally impaired)
2. Unable to produce 2 sputa of ≥ 1ml
3. TB treatment within the last 60 days
4. Unable to potentially return for study follow-up at 2 and 6 months (i.e. leaving community)
5. Patient not meeting inclusion criteria
C: Inclusion Criteria:

1. 2x smear negative or sputum scarce TB suspects
2. Primary care patient (not referred by doctor)
3. Adult patients (\>18 years)
4. Able to provide informed consent

Exclusion Criteria:

1. Not meeting inclusion criteria
2. \<18 years
3. Unable to provide informed consent
D: Inclusion Criteria:

* Individuals must meet all of the following inclusion criteria in order to be eligible to participate:

  * Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age of majority) if enrolled in China
  * Provision of informed consent
  * Clinical signs and/or symptoms suggestive of pulmonary tuberculosis
  * Meets one of the following criteria:

A. Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants).

B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance

Exclusion Criteria:

* Inability to provide a sputum specimen

Answer: C