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

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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, Flach, Clare, Lawn, Stephen D, Fielding, Katherine·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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Figure 1 Trial profile Patients could have more than one reason for exclusion. Data stratified by site are shown in the appendix.
Figure 1 Trial profile Patients could have more than one reason for exclusion. Data stratified by site are shown in the appendix.CC BY · PubMed Central
Figure 2 Primary outcome and predefined subgroup analyses (A), and secondary outcomes (B) All analyses are adjusted for study site. (A) The primary outcome is mortality at 56 days after randomisation. Risk differences are the risk in the intervention group minus the risk in the standard-of-care group. (B) Secondary outcomes are measured at the end of hospital admission except for those who started ART, which is measured at 56 days. Antibacterial treatment excludes anti-TB medications. ART=antiretroviral therapy. *Interaction between study group and subgroup.
Figure 2 Primary outcome and predefined subgroup analyses (A), and secondary outcomes (B) All analyses are adjusted for study site. (A) The primary outcome is mortality at 56 days after randomisation. Risk differences are the risk in the intervention group minus the risk in the standard-of-care group. (B) Secondary outcomes are measured at the end of hospital admission except for those who started ART, which is measured at 56 days. Antibacterial treatment excludes anti-TB medications. ART=antiretroviral therapy. *Interaction between study group and subgroup.CC BY · PubMed Central
Figure 3 Time to 56-day mortality overall and stratified by high-risk subgroups All aHRs were adjusted for study site. (A) Survival analysis over 56 days in the standard-of-care group and intervention group. (B) Survival analysis stratified by CD4 counts less than 100 cells per μL in both groups. (C) Survival analysis stratified by CD4 counts of 100 cells per μL or more in both groups. (D) Survival analysis stratified by haemoglobin of less than 8 g/dL in both groups. (E) Survival analysis stratified by haemoglobin of 8 g/dL or more in both groups. aHR=adjusted hazard ratio.
Figure 3 Time to 56-day mortality overall and stratified by high-risk subgroups All aHRs were adjusted for study site. (A) Survival analysis over 56 days in the standard-of-care group and intervention group. (B) Survival analysis stratified by CD4 counts less than 100 cells per μL in both groups. (C) Survival analysis stratified by CD4 counts of 100 cells per μL or more in both groups. (D) Survival analysis stratified by haemoglobin of less than 8 g/dL in both groups. (E) Survival analysis stratified by haemoglobin of 8 g/dL or more in both groups. aHR=adjusted hazard ratio.CC BY · PubMed Central

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Research works printed but not linked: 1

  1. 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.

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Metadata

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 › Infectious Diseases › 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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