Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Evaluate the Impact of Using a Point-of-care Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients in Resource-poor Settings
Brief Summary: The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with increasing illness severity and more advanced immunosuppression, thus offering the greatest potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4 cell count less than 200). However, in the context of high rates of empiric treatment and the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test is unknown. This study will investigate the impact of the urine LAM strip test. The study hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics (smear microscopy and culture) will significantly improve TB treatment-related outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized patients when compared to standard TB diagnostics alone.


Options:
A: Inclusion Criteria:

* Patients suspected of having pulmonary TB
* Cough ≥ 2 weeks
* At least one other TB clinical symptom

  * Fever
  * Unexplained weight loss
  * Loss of appetite
  * Hemoptysis
  * Shortness of breath
  * Chest pain
  * Night sweats
  * Fatigue
* Suggestive TB on chest x-ray based on pulmonologist or internist consultant of pulmonology opinion
* Age ≥ 18 years' old
* Willing to be treated or evaluated at study site
* Willing to have specimens stored for use in future studies
* Patient denies having TB treatment for more than 7 days in the last 1 month (30 days).

Exclusion Criteria:

Pregnancy or any serious condition includes, but not limited to, liver disease, chronic kidney disease, and psychiatric illness that might interfere with study compliance (based on the clinician judgment).
B: Inclusion Criteria:

* HIV-infected (1x rapid HIV test positive)
* Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW)
* Illness severity sufficient to warrant hospitalization
* ≥18 years old
* Provision of informed consent

Exclusion Criteria:

* HIV-uninfected
* Patients receiving any anti-TB medication in the 60 days prior to testing
* Unable to provide 30mls urine
* Inability to provide informed consent
C: Inclusion Criteria:

* HIV-1 infection
* Willingness to start efavirenz-based ART as soon as possible and within no more than 3 days following randomization.
* CD4+ cell count \<50 cells/mm\^3 obtained within 45 days prior to study entry
* Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and total bilirubin ≤ 2.5 X ULN within 30 days prior to study entry.
* Creatinine clearance ≥30 mL/min either measured or estimated using values obtained within 30 days prior to study entry.
* Results from a hepatitis B surface antigen test performed within 30 days prior to study entry.
* Agreement not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).
* Female candidates of reproductive potential must have a negative serum or urine (15-25 mIU/mL) pregnancy test result within 7 days prior to study entry.
* Female candidates of reproductive potential who are participating in sexual activity that could lead to pregnancy must use two reliable methods of contraception while on study.
* Karnofsky performance score \>/= 30 at time of study entry.
* Ability to swallow medications.
* Ability and willingness of participant or legal guardian/representative to provide informed consent.
* Intention to remain in the same general geographic region for the duration of study participation.

Exclusion Criteria:

* Presence of any confirmed or probable TB based on criteria listed in the current ACTG diagnosis appendix within 30 days prior to study entry and following completion of study-specific screening algorithm.
* Use of single-dose NVP for prevention of mother-to-child transmission (pMTCT) within 24 months prior to study entry.
* Use of prohibited medications within 30 days prior to study entry.
* Known allergy/sensitivity or any hypersensitivity to components of study-required ART or TB treatment.
* Current receipt of treatment for active TB or receipt of \>14 days cumulative treatment for active TB within 96 weeks prior to study entry.
* Receipt of \>30 days cumulative of INH prophylaxis within 48 weeks prior to study entry.
* Receipt at any time prior to study entry of \>7 days cumulative treatment with any ARV or combination of ARVs (except for ARVs taken for any length of time during pregnancy for pMTCT, or ARVs taken for occupational exposure).
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Current Grade ≥2 neuropathy.
* History of multi-drug-resistant (MDR) TB.
* Within 12 weeks prior to entry, exposure to a household member or co-worker with known MDR TB.
D: Inclusion Criteria:

* HIV infection
* Fulfills criteria for antiretroviral therapy (CD4 cell count below 350 cells/ml and/or WHO stage IV)
* Residence in study uptake area
* Written informed consent to participation and to tracing in case of defaulting

Exclusion Criteria:

* Ongoing or previous antiretroviral therapy
* Treatment for active tuberculosis for more than two weeks

Answer: B