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Cited by 213Tuberculosis Research and EpidemiologyInfectious Diseases and TuberculosisHIV/AIDS Research and Interventions

Rapid urine-based screening for tuberculosis in HIV-positive patients admitted to hospital in Africa (STAMP): a pragmatic, multicentre, parallel-group, double-blind, randomised controlled trial

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Gupta-Wright, Ankur, Corbett, Elizabeth L, van Oosterhout, Joep J, Wilson, Douglas, Grint, Daniel, Alufandika-Moyo, Melanie, Peters, Jurgens A, Chiume, Lingstone +3 more·2018·The Lancet
DOI 10.1016/s0140-6736(18)31267-4PMC PMC6078909
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Abstract

BACKGROUND: Current diagnostics for HIV-associated tuberculosis are suboptimal, with missed diagnoses contributing to high hospital mortality and approximately 374 000 annual HIV-positive deaths globally. Urine-based assays have a good diagnostic yield; therefore, we aimed to assess whether urine-based screening in HIV-positive inpatients for tuberculosis improved outcomes. METHODS: We did a pragmatic, multicentre, double-blind, randomised controlled trial in two hospitals in Malawi and South Africa. We included HIV-positive medical inpatients aged 18 years or more who were not taking tuberculosis treatment. We randomly assigned patients (1:1), using a computer-generated list of random block size stratified by site, to either the standard-of-care or the intervention screening group, irrespective of symptoms or clinical presentation. Attending clinicians made decisions about care; and patients, clinicians, and the study team were masked to the group allocation. In both groups, sputum was tested using the Xpert MTB/RIF assay (Xpert; Cepheid, Sunnyvale, CA, USA). In the standard-of-care group, urine samples were not tested for tuberculosis. In the intervention group, urine was tested with the Alere Determine TB-LAM Ag (TB-LAM; Alere, Waltham, MA, USA), and Xpert assays. The primary outcome was all-cause 56-day mortality. Subgroup analyses for the primary outcome were prespecified based on baseline CD4 count, haemoglobin, clinical suspicion for tuberculosis; and by study site and calendar time. We used an intention-to-treat principle for our analyses. This trial is registered with the ISRCTN registry, number ISRCTN71603869. FINDINGS: Between Oct 26, 2015, and Sept 19, 2017, we screened 4788 HIV-positive adults, of which 2600 (54%) were randomly assigned to the study groups (n=1300 for each group). 13 patients were excluded after randomisation from analysis in each group, leaving 2574 in the final intention-to-treat analysis (n=1287 in each group). At admission, 1861 patients were taking antiretroviral therapy and median CD4 count was 227 cells per μL (IQR 79-436). Mortality at 56 days was reported for 272 (21%) of 1287 patients in the standard-of-care group and 235 (18%) of 1287 in the intervention group (adjusted risk reduction [aRD] -2·8%, 95% CI -5·8 to 0·3; p=0·074). In three of the 12 prespecified, but underpowered subgroups, mortality was lower in the intervention group than in the standard-of-care group for CD4 counts less than 100 cells per μL (aRD -7·1%, 95% CI -13·7 to -0·4; p=0.036), severe anaemia (-9·0%, -16·6 to -1·3; p=0·021), and patients with clinically suspected tuberculosis (-5·7%, -10·9 to -0·5; p=0·033); with no difference by site or calendar period. Adverse events were similar in both groups. INTERPRETATION: Urine-based tuberculosis screening did not reduce overall mortality in all HIV-positive inpatients, but might benefit some high-risk subgroups. Implementation could contribute towards global targets to reduce tuberculosis mortality. FUNDING: Joint Global Health Trials Scheme of the Medical Research Council, the UK Department for International Development, and the Wellcome Trust.

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  • In two randomized trials, use of Alere LAM in HIV-positive adult inpatients reduced mortality.

    “In two randomized trials, the use of Alere LAM in HIV‐positive adult inpatients was shown to reduce mortality (Gupta‐Wright 2018; Peter 2016).”

    From Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults (2021) · cites this paper as Gupta‐Wright 2018

    The Results report lower mortality with the screening intervention in three prespecified high-risk subgroups, and the Discussion describes a survival benefit across the two trials. But STAMP found no statistically significant reduction in overall 56-day mortality among all HIV-positive adult inpatients; the unqualified claim overstates its finding. Page numbers are not supplied in the copy. (LLM, conf=0.90)

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Research works printed but not linked: 3

  1. [9]WHO Automated real-time nucleic acid amplifiation technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children: policy update 2013 World Health Organization Geneva 25473701
  2. [25]Reddy KP, Gupta-Wright A, Fielding K, et al. Cost-effectiveness of urine TB screening for hospitalized people with HIV in Africa. The Conference on Retroviruses and Opportunistic Infections (CROI); Boston, MA, USA; 2018. Abstract number 3521.
  3. [33]WHO Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy 2017 World Health Organization Geneva 29341560

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Authors
Gupta-Wright, A., Corbett, E. L., van Oosterhout, J. J., Wilson, D., Grint, D., Alufandika-Moyo, M., Peters, J. A., Chiume, L., Flach, C., Lawn, S. D., & Fielding, K.
Affiliations
  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme (MW)
  • Edendale Hospital (ZA)
  • London School of Hygiene & Tropical Medicine (GB)
  • King's College London (GB)
  • University of the Witwatersrand (ZA)
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2018-07
Volume
392
Issue
10144
Pages
292-301
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(18)31267-4
PMC
PMC6078909
OpenAlex
W2883578784
Cited by
213
References
27
Citations by year
2026: 15 · 2025: 23 · 2024: 17 · 2023: 22 · 2022: 29 · 2021: 18 · 2020: 35 · 2019: 46 · 2018: 8
FWCI
20.20
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • LSTM Online Archive (Liverpool School of Tropical Medicine) (acceptedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • Research Portal (King's College London) (submittedVersion, cc-by)
  • Greater South Information System
Funders
  • Wellcome Trust (WT200901, MR/M007375, WT200901/Z/16/Z, MR/M007375/1)
  • Department for International Development
  • Medical Research Council (MR/M007375/1, MR/K012126/1)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
  • Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Keywords
HIV-associated tuberculosis, tuberculosis screening, Xpert MTB/RIF, in-hospital mortality, CD4 count, antiretroviral therapy, tuberculosis diagnosis, Malawi, South Africa, Africa
MeSH terms
Adult, Developing Countries, Double-Blind Method, Female, HIV Seropositivity, Humans, Malawi, Male, Mass Screening, Middle Aged, Rifampin, South Africa, Sputum, Tuberculosis, Urinalysis, AIDS-Related Opportunistic Infections, Drug Resistance, Bacterial

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