Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial

BACKGROUND: Tuberculosis is the main cause of death among hospitalised people living with HIV. Non-sputum-based diagnostics could improve patient outcomes. The EXULTANT trial aims to evaluate an expanded tuberculosis screening strategy among people with HIV in two African countries with a high tuberculosis and HIV burden. METHODS: This pragmatic, individually randomised controlled superiority trial was conducted across 11 hospitals in Tanzania and Mozambique. We consecutively enrolled adults living with HIV (aged ≥18 years) without an existing tuberculosis diagnosis or recent tuberculosis treatment, within 24 h of admission. The intervention group underwent Xpert MTB/RIF Ultra (Xpert Ultra) testing from sputum, stool, and urine, plus lateral flow urine lipoarabinomannan (LF-LAM) testing (Determine TB LAM Ag assay), irrespective of symptoms. The control group followed standard-of-care, symptom-based, WHO-recommended sputum Xpert Ultra and LF-LAM testing. The primary endpoint was the proportion of participants with microbiologically confirmed tuberculosis starting treatment within 72 h. Secondary endpoints included 8-week all-cause mortality and time to tuberculosis diagnosis. The trial is registered at ClinicalTrials.gov (NCT04568967) and is completed. FINDINGS: From Sept 25, 2022, to March 15, 2024, we screened 1534 participants, and randomly assigned 1172 (76·6%) to either the intervention group (n=582) or the control group (n=590). At admission, 715 participants (61·0%) were female, 845 (75·4%) were on antiretroviral therapy (ART), and median CD4 count was 232 cells per μL (IQR 87-490). In the control group, 505 (85·6%) had tuberculosis-compatible symptoms and were eligible for sputum Xpert Ultra testing (306 of them [60·6%] provided a sample) and 538 (91·2%) met WHO criteria for LF-LAM testing. In the intention-to-treat analysis, 93 (16·0%) of 582 participants in the intervention group and 90 (15·3%) of 590 in the control group had microbiologically confirmed tuberculosis and started treatment within 72 h (difference 0·7%, 95% CI -3·4 to 4·8, p=0·73). 8-week all-cause mortality was 25·8% (150 of 582) in the intervention group and 28·8% (170 of 590) in the control group (hazard ratio 0·86, 95% CI 0·69 to 1·07, p=0·18). Median time to tuberculosis treatment initiation was 0·98 days (IQR 0·83-1·92) and 0·92 days (0·79-1·86) in the intervention and control groups, respectively (hazard ratio 1·05, 95% CI 0·82 to 1·33, p=0·72). INTERPRETATION: An expanded screening strategy among people living with HIV admitted to hospital did not increase the proportion of individuals with microbiologically confirmed tuberculosis starting treatment or reduce 8-week mortality. FUNDING: EDCTP2 programme, supported by the EU.

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Publication Details

Journal
The Lancet Infectious Diseases
Published
2026-05-01
DOI
https://doi.org/10.1016/s1473-3099(26)00133-7
Citations
1
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
19.15

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article

Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial

Swalehe Masoud, J. Buech, Bernard Kivuma, Willyhelmina Olomi et al.
1 citations
The Lancet Infectious Diseases
Tuberculosis Research and Epidemiology
19.15
article

Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial

Swalehe Masoud, J. Buech, Bernard Kivuma, Willyhelmina Olomi, Hélio Chiconela, F. Rieß, Samuel G. Schumacher, Cândido Azize, Shilzia Munguambe, Elisa Tagliani, Berra Erkoşar, Craysophy Zachariah, Morten Rühwald, Celso Khosa, Mohamed Sasamalo, Issa Sabi, Bindiya Meggi, Grace Mhalu, Joanna Ehrlich, Mikaela Watson, Marta Cossa, Claudia Schacht, Sergi Sanz, Laura de la Torre‐Pérez, Hosiana Temba, António Machiana, Délio Elísio, Raphael Edom, Kasmir Johaness, Patricia Manjate, Lonze Ndelwa, Neide Gomes, Muhuminu Nuru, Deogratias Bulime, Petro Sabuni, Jamali Siru, Jonathan Msafiri, Mohamed Mbaruku, Ambilikile Malango, Faith Komakoma, Gloria Msigala, Last Mwaipopo, Claudio Bila, Denise Floripes, Mahmud Mahmud, Katia Ribeiro, Joaquim Cossa, A. S. Leonard, Annastazia Alexander, Regino Mgaya, Frederick Haraka, Sara Kiula, Alfred Danda, Ezequiel Nhamtumbo, Jorge Ribeiro, Francisca Chuwa, N. Ntinginya, Carla Madeira, Helen Cox, Emmanuel Sichone, Sunita Singh, Maja Weisser, Vinzeigh Leukes, Theonestina Byazukana, Jerry Hella, Dorcas Mnzava, Carlos Fernández-Escobar, Sozinho Acacio, Edson Mambuque, Robert Ndege, Adam Penn-Nicholson, Alberto L Garcia-Basteiro, Neema Shija, Nyanda Elias Ntinginya, Bariki Mtafya, Anange F. Lwilla, Omary Ngome, Chacha Mangu, Dinis Nguenha, Katharina Kranzer, Lewis Batao, Leslie Scott
article en
1 citations

Abstract

BACKGROUND: Tuberculosis is the main cause of death among hospitalised people living with HIV. Non-sputum-based diagnostics could improve patient outcomes. The EXULTANT trial aims to evaluate an expanded tuberculosis screening strategy among people with HIV in two African countries with a high tuberculosis and HIV burden. METHODS: This pragmatic, individually randomised controlled superiority trial was conducted across 11 hospitals in Tanzania and Mozambique. We consecutively enrolled adults living with HIV (aged ≥18 years) without an existing tuberculosis diagnosis or recent tuberculosis treatment, within 24 h of admission. The intervention group underwent Xpert MTB/RIF Ultra (Xpert Ultra) testing from sputum, stool, and urine, plus lateral flow urine lipoarabinomannan (LF-LAM) testing (Determine TB LAM Ag assay), irrespective of symptoms. The control group followed standard-of-care, symptom-based, WHO-recommended sputum Xpert Ultra and LF-LAM testing. The primary endpoint was the proportion of participants with microbiologically confirmed tuberculosis starting treatment within 72 h. Secondary endpoints included 8-week all-cause mortality and time to tuberculosis diagnosis. The trial is registered at ClinicalTrials.gov (NCT04568967) and is completed. FINDINGS: From Sept 25, 2022, to March 15, 2024, we screened 1534 participants, and randomly assigned 1172 (76·6%) to either the intervention group (n=582) or the control group (n=590). At admission, 715 participants (61·0%) were female, 845 (75·4%) were on antiretroviral therapy (ART), and median CD4 count was 232 cells per μL (IQR 87-490). In the control group, 505 (85·6%) had tuberculosis-compatible symptoms and were eligible for sputum Xpert Ultra testing (306 of them [60·6%] provided a sample) and 538 (91·2%) met WHO criteria for LF-LAM testing. In the intention-to-treat analysis, 93 (16·0%) of 582 participants in the intervention group and 90 (15·3%) of 590 in the control group had microbiologically confirmed tuberculosis and started treatment within 72 h (difference 0·7%, 95% CI -3·4 to 4·8, p=0·73). 8-week all-cause mortality was 25·8% (150 of 582) in the intervention group and 28·8% (170 of 590) in the control group (hazard ratio 0·86, 95% CI 0·69 to 1·07, p=0·18). Median time to tuberculosis treatment initiation was 0·98 days (IQR 0·83-1·92) and 0·92 days (0·79-1·86) in the intervention and control groups, respectively (hazard ratio 1·05, 95% CI 0·82 to 1·33, p=0·72). INTERPRETATION: An expanded screening strategy among people living with HIV admitted to hospital did not increase the proportion of individuals with microbiologically confirmed tuberculosis starting treatment or reduce 8-week mortality. FUNDING: EDCTP2 programme, supported by the EU.

The Lancet Infectious Diseases
Ifakara Health Institute (TZ), University of London (GB), FIND (CH), Vita-Salute San Raffaele University (IT), Swiss Tropical and Public Health Institute (CH), University of the Witwatersrand (ZA), German Agency for Quality in Medicine (DE), LMU Klinikum (DE), London School of Hygiene & Tropical Medicine (GB), Manhiça Health Research Centre (MZ), Instituto Nacional de Saúde (MZ), Wellcome Centre for Infectious Diseases Research in Africa (ZA), Barcelona Institute for Global Health (ES), Istituti di Ricovero e Cura a Carattere Scientifico (IT), National Institute for Medical Research (TZ), Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele (IT), Universitat de Barcelona (ES), Ludwig-Maximilians-Universität München (DE)
European and Developing Countries Clinical Trials Partnership
Good health and well-being
Openalex Percentile: Top 1%
Tuberculosis Research and Epidemiology
19.15
DOIOpen Access PDFOpenAlex
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