Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial

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dc.contributor.authorCox, Helen Sen_ZA
dc.contributor.authorMbhele, Slindileen_ZA
dc.contributor.authorMohess, Neishaen_ZA
dc.contributor.authorWhitelaw, Andrewen_ZA
dc.contributor.authorMuller, Odeliaen_ZA
dc.contributor.authorZemanay, Widaaden_ZA
dc.contributor.authorLittle, Francescaen_ZA
dc.contributor.authorAzevedo, Virginiaen_ZA
dc.contributor.authorSimpson, Johnen_ZA
dc.contributor.authorBoehme, Catharina Cen_ZA
dc.contributor.authorNicol, Mark Pen_ZA
dc.date.accessioned2015-12-28T06:51:41Z
dc.date.available2015-12-28T06:51:41Z
dc.date.issued2014en_ZA
dc.description.abstractBackground: Xpert MTB/RIF is approved for use in tuberculosis (TB) and rifampicin-resistance diagnosis. However, data are limited on the impact of Xpert under routine conditions in settings with high TB burden. Methods and Findings: A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive (symptomatic) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic. The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation. Secondary outcomes included time to TB treatment and mortality. Unblinded randomisation occurred on a weekly basis. Xpert and smear microscopy were performed on site. Analysis was both by intention to treat (ITT) and per protocol. Between 7 September 2010 and 28 October 2011, 1,985 participants were assigned to the Xpert (n = 982) and routine (n = 1,003) diagnostic algorithms (ITT analysis); 882 received Xpert and 1,063 routine (per protocol analysis). 13% (32/257) of individuals with bacteriologically confirmed TB (smear, culture, or Xpert) did not initiate treatment by 3 mo after presentation in the Xpert arm, compared to 25% (41/167) in the routine arm (ITT analysis, risk ratio 0.51, 95% CI 0.33–0.77, p = 0.0052). The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17% (167/1,003) with routine diagnosis and 26% (257/982) with Xpert diagnosis (ITT analysis, risk ratio 1.57, 95% CI 1.32–1.87, p<0.001). This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm: 23% (229/1,003) and 28% (277/982) in the routine and Xpert arms, respectively (ITT analysis, risk ratio 1.24, 95% CI 1.06–1.44, p = 0.013). Time to treatment initiation was improved overall (ITT analysis, hazard ratio 0.76, 95% CI 0.63–0.92, p = 0.005) and among HIV-infected participants (ITT analysis, hazard ratio 0.67, 95% CI 0.53–0.85, p = 0.001). There was no difference in 6-mo mortality with Xpert versus routine diagnosis. Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic. Conclusions: These data suggest that in this routine primary care setting, use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation, particularly among HIV-infected participants.en_ZA
dc.identifier.apacitationCox, H. S., Mbhele, S., Mohess, N., Whitelaw, A., Muller, O., Zemanay, W., ... Nicol, M. P. (2014). Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. <i>PLOS Medicince</i>, http://hdl.handle.net/11427/16068en_ZA
dc.identifier.chicagocitationCox, Helen S, Slindile Mbhele, Neisha Mohess, Andrew Whitelaw, Odelia Muller, Widaad Zemanay, Francesca Little, et al "Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial." <i>PLOS Medicince</i> (2014) http://hdl.handle.net/11427/16068en_ZA
dc.identifier.citationCox, H. S., Mbhele, S., Mohess, N., Whitelaw, A., Muller, O., Zemanay, W., ... & Nicol, M. P. (2014). Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. PLoS Med, 11(11), e1001760. doi:10.1371/journal.pmed.1001760en_ZA
dc.identifier.ris TY - Journal Article AU - Cox, Helen S AU - Mbhele, Slindile AU - Mohess, Neisha AU - Whitelaw, Andrew AU - Muller, Odelia AU - Zemanay, Widaad AU - Little, Francesca AU - Azevedo, Virginia AU - Simpson, John AU - Boehme, Catharina C AU - Nicol, Mark P AB - Background: Xpert MTB/RIF is approved for use in tuberculosis (TB) and rifampicin-resistance diagnosis. However, data are limited on the impact of Xpert under routine conditions in settings with high TB burden. Methods and Findings: A pragmatic prospective cluster-randomised trial of Xpert for all individuals with presumptive (symptomatic) TB compared to the routine diagnostic algorithm of sputum microscopy and limited use of culture was conducted in a large TB/HIV primary care clinic. The primary outcome was the proportion of bacteriologically confirmed TB cases not initiating TB treatment by 3 mo after presentation. Secondary outcomes included time to TB treatment and mortality. Unblinded randomisation occurred on a weekly basis. Xpert and smear microscopy were performed on site. Analysis was both by intention to treat (ITT) and per protocol. Between 7 September 2010 and 28 October 2011, 1,985 participants were assigned to the Xpert (n = 982) and routine (n = 1,003) diagnostic algorithms (ITT analysis); 882 received Xpert and 1,063 routine (per protocol analysis). 13% (32/257) of individuals with bacteriologically confirmed TB (smear, culture, or Xpert) did not initiate treatment by 3 mo after presentation in the Xpert arm, compared to 25% (41/167) in the routine arm (ITT analysis, risk ratio 0.51, 95% CI 0.33–0.77, p = 0.0052). The yield of bacteriologically confirmed TB cases among patients with presumptive TB was 17% (167/1,003) with routine diagnosis and 26% (257/982) with Xpert diagnosis (ITT analysis, risk ratio 1.57, 95% CI 1.32–1.87, p<0.001). This difference in diagnosis rates resulted in a higher rate of treatment initiation in the Xpert arm: 23% (229/1,003) and 28% (277/982) in the routine and Xpert arms, respectively (ITT analysis, risk ratio 1.24, 95% CI 1.06–1.44, p = 0.013). Time to treatment initiation was improved overall (ITT analysis, hazard ratio 0.76, 95% CI 0.63–0.92, p = 0.005) and among HIV-infected participants (ITT analysis, hazard ratio 0.67, 95% CI 0.53–0.85, p = 0.001). There was no difference in 6-mo mortality with Xpert versus routine diagnosis. Study limitations included incorrect intervention allocation for a high proportion of participants and that the study was conducted in a single clinic. Conclusions: These data suggest that in this routine primary care setting, use of Xpert to diagnose TB increased the number of individuals with bacteriologically confirmed TB who were treated by 3 mo and reduced time to treatment initiation, particularly among HIV-infected participants. DA - 2014 DB - OpenUCT DO - 10.1371/journal.pmed.1001760 DP - University of Cape Town J1 - PLOS Medicince LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 T1 - Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial TI - Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial UR - http://hdl.handle.net/11427/16068 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/16068
dc.identifier.urihttp://dx.doi.org/10.1371/journal.pmed.1001760
dc.identifier.vancouvercitationCox HS, Mbhele S, Mohess N, Whitelaw A, Muller O, Zemanay W, et al. Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. PLOS Medicince. 2014; http://hdl.handle.net/11427/16068.en_ZA
dc.language.isoengen_ZA
dc.publisherPublic Library of Scienceen_ZA
dc.publisher.departmentDivision of Medical Biochemistryen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_ZA
dc.rights.holder© 2014 Cox et alen_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/4.0en_ZA
dc.sourcePLOS Medicinceen_ZA
dc.source.urihttp://journals.plos.org/plosmedicineen_ZA
dc.subject.otherTuberculosisen_ZA
dc.subject.otherTuberculosis diagnosis and managementen_ZA
dc.subject.otherMycobacterium tuberculosisen_ZA
dc.subject.otherSputumen_ZA
dc.subject.otherDiagnostic medicineen_ZA
dc.subject.otherHIV diagnosis and managementen_ZA
dc.subject.otherHIVen_ZA
dc.subject.otherExtensively drug-resistant tuberculosisen_ZA
dc.titleImpact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trialen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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