Please select the arm or intervention descriptions that belong 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: Arm Label: PLHIV Centralised Xpert Ultra; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PLHIV Point of Care Xpert Ultra; Type: ACTIVE_COMPARATOR; Interventions: Diagnostic Test: PLHIV Point of Care Xpert Ultra | Arm Label: PLHIV Centralised Xpert VL; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: PLHIV Point of Care Xpert VL; Type: ACTIVE_COMPARATOR; Interventions: Diagnostic Test: PLHIV Point of Care Xpert VL | Intervention Type: DIAGNOSTIC_TEST; Name: PLHIV Point of Care Xpert Ultra; Assigned to Arm(s): PLHIV Point of Care Xpert Ultra | Intervention Type: DIAGNOSTIC_TEST; Name: PLHIV Point of Care Xpert VL; Assigned to Arm(s): PLHIV Point of Care Xpert VL
B: Intervention Type: OTHER; Name: Development of a diagnosis algorithm; Assigned to Arm(s): N/A
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Interventional; Type: EXPERIMENTAL; Interventions: Diagnostic Test: Xpert MTB/RIF Ultra (Ultra) | Intervention Type: DIAGNOSTIC_TEST; Name: Xpert MTB/RIF Ultra (Ultra); Assigned to Arm(s): Interventional
D: Arm Label: Centralised Xpert®Ultra testing; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Xpert Ultra Point of Care testing; Type: ACTIVE_COMPARATOR; Interventions: Diagnostic Test: Xpert Ultra Point of Care testing | Intervention Type: DIAGNOSTIC_TEST; Name: Xpert Ultra Point of Care testing; Assigned to Arm(s): Xpert Ultra Point of Care testing

Answer: A