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, Madalo, Twabi, Hussein H, Msefula, Chisomo, Semphere, Robina, Ndhlovu, Gabriel, Lipenga, Trancizeo, Sikwese, Tionge Daston, Malisita, Kenneth, Choko, Augustine, Corbett, Elizabeth L, MacPherson, Peter ORCID: https://orcid.org/0000-0002-0329-9613 and Nliwasa, Marriott (2022) '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, Vol 117, Issue 1, pp. 28-37.

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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:	Article
Subjects:	WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503.5 Complications WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General) WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
Faculty: Department:	Clinical Sciences & International Health > Malawi-Liverpool-Wellcome Programme (MLW)
Digital Object Identifer (DOI):	https://doi.org/10.1093/trstmh/trac079
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	18 Oct 2022 11:39
Last Modified:	02 Feb 2023 11:26
URI:	https://archive.lstmed.ac.uk/id/eprint/21027

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