Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feasibility, Accuracy, and Effect of Polyvalent Point-of-care Xpert MTB/RIF Ultra and Xpert HIV-1 Viral Load Testing in HIV-positive Patients Initiating ART: a Randomised Controlled Trial
Brief Summary: TB is increasingly diagnosed using the GeneXpert platform, which can be used for a variety of tests (not just TB). HIV viral load monitoring is required at least annually in patients on ART to detect failure of virologic suppression, however, most HIV VL testing is done centrally. A patient with virologic failure is more likely to get TB.

The investigators wish to see if Xpert done at the clinic results in faster patient TB diagnosis and treatment initiation compared to sending specimens away for central testing. In a different patient group (PLHIV returning for HIV treatment monitoring), the investigators wish to see if POC Xpert HIV-1 viral load (Xpert VL) testing results in faster patient viral load quantification compared to centralised testing. Both POC tests will use the same testing hardware. This polyvalent utility of the GeneXpert system is hitherto uninvestigated in this local setting.

Newly diagnosed pre-ART HIV positive patients will be approached and asked to be a part of this study. Patients will be randomly assigned to Ultra done at the clinic or the normal off-site laboratory TB testing. The time taken for patients to get diagnosed and time-to-treatment will be recorded. We will also do exploratory diagnostic accuracy evaluations including but not limited to, Ultra when done on mouth samples, the new SILVAMP FujiLAM on urine, and host RNA blood signatures for active TB. Additionally, a different group of HIV positive patients (on ART) returning to the clinic for annual follow-up visits will also be asked to join the study. These patients will be randomly selected for either Xpert VL testing done at the clinic or the normal off-site testing. The time taken for patients to receive viral load results will be recorded. Should the patient's viral loads be found to be higher than anticipated and considered by the clinical to indicate a lack of viral suppression, the time taken for patients to have ART regimen adjusted, receive adherence counselling or received HIV drug susceptibility testing will be recorded.

This project will confirm if Ultra TB testing performs well in PLHIV irrespective of symptoms and may produce evidence that supports universal TB testing in this important and vulnerable patient group, including using novel diagnostics on non-traditional specimen types. The investigators will also assess whether POC placement of Ultra and Xpert VL has benefits (e.g., more patients diagnosed for TB or VL monitored during the same day visit).


Options:
A: Inclusion Criteria:

* Suspected pulmonary TB.
* Ability and willingness of candidate or legal guardian/representative to provide informed consent.
* Men and women age equal to or greater than 18 years.

Exclusion Criteria:

* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
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: HIV-positive viral load monitoring patients

Inclusion Criteria:

* Informed consent obtained from patient
* Patient is more than 18 years old
* Patient is HIV positive
* Patient is receiving follow-up ART
* Patient is willing to provide blood specimens for study

Exclusion Criteria:

* Informed consent not obtained from patient
* Patient is less than 18 years old
* Patient is HIV negative or has unknown HIV status
* Patient is coming into clinic for first time ART
* Patient is not willing to provide blood specimens for study

TB patients

Inclusion Criteria:

* Informed consent obtained from patient
* Patient is more than 18 years old
* Patient is HIV positive
* Patient is coming into clinic for first ART visit
* Patient is willing to provide sputum and urine (blood is desirable, but not mandatory) specimens for study

Exclusion Criteria:

* Informed consent not obtained from patient
* Patient is less than 18 years old
* Patient is HIV negative or has unknown HIV status
* Patient is not coming into clinic for first time ART
* Patient has been on TB treatment within the last 60 days
* Patient is not willing to provide sputum and urine specimens for study
D: Inclusion Criteria:

-

Program Implementation:

Inclusion criteria:

* Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
* Ability to produce sputum
* Verbal consent of parent or guardian if \< 18 years old

Operations Research:

Inclusion criteria

* Adults (18 years and older)
* TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
* Ability to provide a sputum sample
* Willing to provide written informed consent
* Willing to undergo full clinical evaluation
* Willing to undergo a CXR

Answer: C