Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial

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dc.contributor.authorGupta-Wright, Ankur
dc.contributor.authorFielding, Katherine L
dc.contributor.authorvan Oosterhout, Joep J
dc.contributor.authorWilson, Douglas K
dc.contributor.authorCorbett, Elizabeth L
dc.contributor.authorFlach, Clare
dc.contributor.authorReddy, Krishna P
dc.contributor.authorWalensky, Rochelle P
dc.contributor.authorPeters, Jurgens A
dc.contributor.authorAlufandika-Moyo, Melanie
dc.contributor.authorLawn, Stephen D
dc.date.accessioned2021-10-08T06:20:28Z
dc.date.available2021-10-08T06:20:28Z
dc.date.issued2016
dc.description.abstractAbstract Background HIV-associated tuberculosis (TB) co-infection remains an enormous burden to international public health. Post-mortem studies have highlighted the high proportion of HIV-positive adults admitted to hospital with TB. Determine TB-LAM and Xpert MTB/RIF assays can substantially increase diagnostic yield of TB within one day of hospital admission. However, it remains unclear if this approach can impact clinical outcomes. The STAMP trial aims to test the hypothesis that the implementation a urine-based screening strategy for TB can reduce all cause-mortality among HIV-positive patients admitted to hospital when compared to current, sputum-based screening. Methods The trial is a pragmatic, individually randomised, multi-country (Malawi and South Africa) clinical trial with two study arms (1:1 recruitment). Unselected HIV-positive patients admitted to medical wards, irrespective of presentation, meeting the inclusion criteria and giving consent will be randomized to screening for TB using either: (i) ‘standard of care’- testing of sputum using the Xpert MTB/RIF assay (Xpert) or (ii) ‘intervention’- testing of sputum using Xpert and testing of urine using (a) Determine TB-LAM lateral-flow assay and (b) Xpert following concentration of urine by centrifugation. Patients will be excluded if they have received TB treatment in the previous 12 months, if they have received isoniazid preventive therapy in the last 6 months, if they are aged <18 years or they live outside the pre-specified geographical area. Results will be provided to the responsible medical team as soon as available to inform decisions regarding TB treatment. Both the study and routine medical team will be masked to study arm allocation. 1300 patients will be enrolled per arm (equal numbers at the two trial sites). The primary endpoint is all-cause mortality at 56 days. An economic analysis will be conducted to project long-term outcomes for shorter-term trial data, including cost-effectiveness. Discussion This pragmatic trial assesses an intervention to reduce the high mortality caused by HIV-associated TB, which could feasibly be scaled up in high-burden settings if shown to be efficacious and cost-effective. We discuss the challenges of designing a trial to assess the impact on mortality of laboratory-based TB screening interventions given frequent initiation of empirical treatment and a failure of several previous clinical trials to demonstrate an impact on clinical outcomes. We also elaborate on the practical and ethical issues of ‘testing a test’ in general. Trial registration ISRCTN Registry (ISRCTN71603869) prospectively registered 08 May 2015; the South African National Controlled Trials Registry (DOH-27-1015-5185) prospectively registered October 2015.
dc.identifier.apacitationGupta-Wright, A., Fielding, K. L., van Oosterhout, J. J., Wilson, D. K., Corbett, E. L., Flach, C., ... Lawn, S. D. (2016). Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial. <i>BMC Infectious Diseases</i>, 16(1), 174 - 177. http://hdl.handle.net/11427/34284en_ZA
dc.identifier.chicagocitationGupta-Wright, Ankur, Katherine L Fielding, Joep J van Oosterhout, Douglas K Wilson, Elizabeth L Corbett, Clare Flach, Krishna P Reddy, et al "Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial." <i>BMC Infectious Diseases</i> 16, 1. (2016): 174 - 177. http://hdl.handle.net/11427/34284en_ZA
dc.identifier.citationGupta-Wright, A., Fielding, K.L., van Oosterhout, J.J., Wilson, D.K., Corbett, E.L., Flach, C., Reddy, K.P. & Walensky, R.P. et al. 2016. Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial. <i>BMC Infectious Diseases.</i> 16(1):174 - 177. http://hdl.handle.net/11427/34284en_ZA
dc.identifier.issn1471-2334
dc.identifier.ris TY - Journal Article AU - Gupta-Wright, Ankur AU - Fielding, Katherine L AU - van Oosterhout, Joep J AU - Wilson, Douglas K AU - Corbett, Elizabeth L AU - Flach, Clare AU - Reddy, Krishna P AU - Walensky, Rochelle P AU - Peters, Jurgens A AU - Alufandika-Moyo, Melanie AU - Lawn, Stephen D AB - Abstract Background HIV-associated tuberculosis (TB) co-infection remains an enormous burden to international public health. Post-mortem studies have highlighted the high proportion of HIV-positive adults admitted to hospital with TB. Determine TB-LAM and Xpert MTB/RIF assays can substantially increase diagnostic yield of TB within one day of hospital admission. However, it remains unclear if this approach can impact clinical outcomes. The STAMP trial aims to test the hypothesis that the implementation a urine-based screening strategy for TB can reduce all cause-mortality among HIV-positive patients admitted to hospital when compared to current, sputum-based screening. Methods The trial is a pragmatic, individually randomised, multi-country (Malawi and South Africa) clinical trial with two study arms (1:1 recruitment). Unselected HIV-positive patients admitted to medical wards, irrespective of presentation, meeting the inclusion criteria and giving consent will be randomized to screening for TB using either: (i) ‘standard of care’- testing of sputum using the Xpert MTB/RIF assay (Xpert) or (ii) ‘intervention’- testing of sputum using Xpert and testing of urine using (a) Determine TB-LAM lateral-flow assay and (b) Xpert following concentration of urine by centrifugation. Patients will be excluded if they have received TB treatment in the previous 12 months, if they have received isoniazid preventive therapy in the last 6 months, if they are aged <18 years or they live outside the pre-specified geographical area. Results will be provided to the responsible medical team as soon as available to inform decisions regarding TB treatment. Both the study and routine medical team will be masked to study arm allocation. 1300 patients will be enrolled per arm (equal numbers at the two trial sites). The primary endpoint is all-cause mortality at 56 days. An economic analysis will be conducted to project long-term outcomes for shorter-term trial data, including cost-effectiveness. Discussion This pragmatic trial assesses an intervention to reduce the high mortality caused by HIV-associated TB, which could feasibly be scaled up in high-burden settings if shown to be efficacious and cost-effective. We discuss the challenges of designing a trial to assess the impact on mortality of laboratory-based TB screening interventions given frequent initiation of empirical treatment and a failure of several previous clinical trials to demonstrate an impact on clinical outcomes. We also elaborate on the practical and ethical issues of ‘testing a test’ in general. Trial registration ISRCTN Registry (ISRCTN71603869) prospectively registered 08 May 2015; the South African National Controlled Trials Registry (DOH-27-1015-5185) prospectively registered October 2015. DA - 2016 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Infectious Diseases LK - https://open.uct.ac.za PY - 2016 SM - 1471-2334 T1 - Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial TI - Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial UR - http://hdl.handle.net/11427/34284 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/34284
dc.identifier.vancouvercitationGupta-Wright A, Fielding KL, van Oosterhout JJ, Wilson DK, Corbett EL, Flach C, et al. Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial. BMC Infectious Diseases. 2016;16(1):174 - 177. http://hdl.handle.net/11427/34284.en_ZA
dc.language.isoeng
dc.publisher.departmentDesmond Tutu HIV Centre
dc.publisher.facultyFaculty of Health Sciences
dc.sourceBMC Infectious Diseases
dc.source.journalissue1
dc.source.journalvolume16
dc.source.pagination174 - 177
dc.source.urihttps://dx.doi.org/10.1186/s12879-016-1837-z
dc.subject.otherHIV
dc.subject.otherHIV-associated TB
dc.subject.otherLAM
dc.subject.otherScreening
dc.subject.otherTB
dc.subject.otherXpert
dc.subject.otherAIDS-Related Opportunistic Infections
dc.subject.otherAcquired Immunodeficiency Syndrome
dc.subject.otherAdult
dc.subject.otherHIV Infections
dc.subject.otherHospitalization
dc.subject.otherHumans
dc.subject.otherIsoniazid
dc.subject.otherMalawi
dc.subject.otherMass Screening
dc.subject.otherRandomized Controlled Trials as Topic
dc.subject.otherSouth Africa
dc.subject.otherSputum
dc.titleRapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial
dc.typeJournal Article
uct.type.publicationResearch
uct.type.resourceJournal Article
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