Utility of Xpert MTB/RIF Ultra and digital chest radiography for the diagnosis and treatment of TB in people living with HIV: a randomised controlled trial (XACT-TB)

Mukoka, M. et al. (2023) Utility of Xpert MTB/RIF Ultra and digital chest radiography for the diagnosis and treatment of TB in people living with HIV: a randomised controlled trial (XACT-TB). Transactions of the Royal Society of Tropical Medicine and Hygiene, 117(1), pp. 28-37. (doi: 10.1093/trstmh/trac079) (PMID:35963826) (PMCID:PMC9808509)

Abstract

Background: TB is a leading cause of morbidity among HIV positive individuals. Accurate algorithms are needed to achieve early TB diagnosis and treatment. We investigated the use of Xpert MTB/RIF Ultra in combination with chest radiography for TB diagnosis in ambulatory HIV positive individuals. Methods: This was a randomised controlled trial with a 2-by-2 factorial design. Outpatient HIV clinic attendees with cough were randomised to four arms: Arm 1-Standard Xpert/no chest radiography (CXR); Arm 2-Standard Xpert/CXR; Arm 3-Xpert Ultra/no CXR; and Arm 4-Xpert Ultra/CXR. Participants were followed up at days 28 and 56 to assess for TB treatment initiation. Results: We randomised 640 participants. Bacteriologically confirmed TB treatment initiation at day 28 were: Arm 1 (8.4% [14/162]), Arm 2 (6.9% [11/159]), Arm 3 (8.2% [13/159]) and Arm 4 (5.6% [9/160]) and between Xpert Ultra group (Arms 3 and 4) (6.9% [22/319]) vs Standard Xpert group (Arms 1 and 2) (7.8% [25/321]), risk ratio 0.89 (95% CI 0.51 to 1.54). By day 56, there were also similar all-TB treatment initiations in the x-ray group (Arms 2 and 4) (16.0% [51/319]) compared with the no x-ray group (Arms 1 and 3) (13.1% [42/321]), risk ratio 1.22 (95% CI 0.84 to 1.78); however, the contribution of clinically diagnosed treatment initiations were higher in x-ray groups (50.9% vs 19.0%). Conclusions: Xpert Ultra performed similarly to Xpert MTB/RIF. X-rays are useful for TB screening but further research should investigate how to mitigate false-positive treatment initiations.

• Item Type: Articles
• Additional Information: This work was supported by the Helse Nord RHF and the Foundation For Innovative New Diagnostics. ELC was funded by a Wellcome Senior Fellowship in Clinical Science [WT200901]. PM was funded by Wellcome [206575/Z/17/Z].
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: MacPherson, Professor Peter
• Authors: Mukoka, M., Twabi, H. H., Msefula, C., Semphere, R., Ndhlovu, G., Lipenga, T., Sikwese, T. D., Malisita, K., Choko, A., Corbett, E. L., MacPherson, P., and Nliwasa, M.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Public Health
• Journal Name: Transactions of the Royal Society of Tropical Medicine and Hygiene
• Publisher: Oxford University Press
• ISSN: 0035-9203
• ISSN (Online): 1878-3503
• Published Online: 13 August 2022
• Copyright Holders: Copyright © The Author(s) 2022
• First Published: First published in Transactions of the Royal Society of Tropical Medicine and Hygiene 117(1):28-37
• Publisher Policy: Reproduced under a Creative Commons licence