NCT03187964

Xpert Ultra and Xpert HIV-VL in People Living With HIV

Completed NA Last updated 5 April 2022

What this trial tests

NA trial testing PLHIV Point of Care Xpert Ultra in HIV/AIDS in 1,053 participants. Completed in 4 April 2022.

Timeline

5 February 2018

Primary endpoint
16 January 2022

4 April 2022

Quick facts

Lead sponsor	University of Stellenbosch
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	1,053
Start date	5 February 2018
Primary completion	16 January 2022
Estimated completion	4 April 2022
Sites	1 location across South Africa

Drugs / interventions tested

• PLHIV Point of Care Xpert Ultra
• PLHIV Point of Care Xpert VL

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• TB - Tuberculosis — all drugs for TB - Tuberculosis →
• Antiretroviral Therapy, Highly Active — all drugs for Antiretroviral Therapy, Highly Active →

Sponsor

University of Stellenbosch

Who can join

18 and older, any sex, with HIV/AIDS or TB - Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults.
   Horne DJ, Kohli M, Zifodya JS, Schiller I, et al · · 2019 · cited 178× · PMID 31173647 · DOI 10.1002/14651858.cd009593.pub4
2. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis.
   Zifodya JS, Kreniske JS, Schiller I, Kohli M, et al · · 2021 · cited 136× · PMID 33616229 · DOI 10.1002/14651858.cd009593.pub5
3. Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.
   Drain PK, Dorward J, Bender A, Lillis L, et al · · 2019 · cited 103× · PMID 31092508 · DOI 10.1128/cmr.00097-18
4. Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.
   Drain PK, Dorward J, Violette LR, Quame-Amaglo J, et al · · 2020 · cited 91× · PMID 32105625 · DOI 10.1016/s2352-3018(19)30402-3
5. Point-of-care C-reactive protein and Xpert MTB/RIF Ultra for tuberculosis screening and diagnosis in unselected antiretroviral therapy initiators: a prospective, cross-sectional, diagnostic accuracy study.
   Reeve BWP, Ndlangalavu G, Mishra H, Palmer Z, et al · · 2024 · cited 22× · PMID 38583458 · DOI 10.1016/s2214-109x(24)00052-4
6. Point-of-care viral load tests to detect high HIV viral load in people living with HIV/AIDS attending health facilities.
   Ochodo EA, Olwanda EE, Deeks JJ, Mallett S. · · 2022 · cited 18× · PMID 35266555 · DOI 10.1002/14651858.cd013208.pub2
7. Sputum scarcity and associated factors in people undergoing tuberculosis testing in South Africa, Uganda, India, and the Philippines: an analysis of cross-sectional observational data.
   Nwamba WV, Okunola AO, Crowder R, Christopher DJ, et al · · 2026 · PMID 42180402 · DOI 10.1016/j.eclinm.2026.103977