Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa- a Randomized Controlled Trial (XACT)
Brief Summary: The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.


Options:
A: Inclusion Criteria:

All HIV-infected men and women \> 18 years of age with newly diagnosed HIV at the 12 study clinics will be asked to participate in the study.

Exclusion Criteria:

* Patients will be excluded from participation if they have a current diagnosis of TB and/or if they are currently taking IPT, TB treatment and/or ART.
* Patients will also be excluded from participation if they cannot speak English or Chichewa;
* if they have a language or hearing impairment; or
* if they are prisoners.
B: Inclusion Criteria:

1. Community participant willing to complete community-based symptom screening, urine testing and/or undergo TB diagnostic tests at the local TB clinic.
2. Provision of informed consent.
3. HIV-negative adults (older than 18 years) with 1 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
4. Any HIV+ve adult (older than 18 years).

Exclusion Criteria:

1. Inability to provide informed consent (e.g. mentally impaired).
2. Patients self-presenting to the TB clinics.
C: 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
D: Inclusion Criteria:

laboratories -and not subjects - will be randomized. All laboratories will start doing smears, when indicated by randomization, they will switch to Xpert MTB/Rif. There are no inclusion or exclusion criteria for the labs. Sputum specimens from non-diagnostic (follow up) patients, second samples for diagnostic tests, insufficient volume/visible blood specimens will be excluded from the Xpert testing.

Answer: B