{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T06:22:50Z","timestamp":1793686970614,"version":"4.5.1"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,12,1]],"date-time":"2019-12-01T00:00:00Z","timestamp":1575158400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,12,16]],"date-time":"2019-12-16T00:00:00Z","timestamp":1576454400000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"This research has been supported by the President\u2019s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention.","award":["Not Applicable"],"award-info":[{"award-number":["Not Applicable"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Infect Dis"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Xpert\u00ae MTB\/RIF (Xpert) has high sensitivity for diagnosing tuberculosis (TB) compared to sputum-smear microscopy (smear) and can reduce time-to-diagnosis, time-to-treatment and potentially unfavorable patient-level treatment outcome.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>People living with HIV (PLHIV) initiating antiretroviral therapy at 22 HIV clinics were enrolled and underwent systematic screening for TB (August 2012\u2013November 2014). GeneXpert instruments were deployed following a stepped-wedge design at 13 centers from October 2012\u2013June 2013. Treatment outcomes classified as an unfavorable outcome (died, treatment failure or loss-to-follow-up) or favorable outcome (cured and treatment completed). To determine outcome, smear was performed at month 5 or 6. Empiric treatment was defined as initiating treatment without\/before receiving TB-positive results. Adjusting for intra-facility correlation, we compared patient-level treatment outcomes between patients screened using smear (smear arm)- and Xpert-based algorithms (Xpert arm).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Among 6041 patients enrolled (smear arm, 1816; Xpert arm, 4225), 256 (199 per 2985 and 57 per 1582 person-years of follow-up in Xpert and smear arms, respectively; adjusted incidence rate ratio, 9.07; 95% confidence interval [CI]: 4.70\u201317.48; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) received TB diagnosis and were treated. TB treatment outcomes were available for 203 patients (79.3%; Xpert, 157; smear, 46). Unfavorable outcomes were reported for 21.7% (10\/46) in the smear and 13.4% (21\/157) in Xpert arm (adjusted hazard ratio, 1.40; 95% CI: 0.75\u20132.26; <jats:italic>p<\/jats:italic>\u2009=\u20090.268). Compared to smear, in Xpert arm median days from sputum collection to TB treatment was 6\u2009days (interquartile range [IQR] 2\u201317 versus 22\u2009days [IQR] 3\u201351), <jats:italic>p<\/jats:italic>\u2009=\u20090.005; patients with available sputum test result had microbiologically confirmed TB in 59.0% (102\/173) versus 41.9% (18\/43), adjusted Odds Ratio [aOR], 2.00, 95% CI: 1.01\u20133.96, <jats:italic>p<\/jats:italic>\u2009=\u20090.048). In smear arm empiric treatment was 68.4% (39\/57) versus 48.7% (97\/199), aOR, 2.28, 95% CI: 1.24\u20134.20, <jats:italic>p<\/jats:italic>\u2009=\u20090.011), compared to Xpert arm.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>TB treatment outcomes were similar between the smear and Xpert arms. However, compared to the smear arm, more patients in the Xpert arm received a TB diagnosis, had a microbiologically confirmed TB, and had a shorter time-to-treatment, and had a lower empiric treatment. Further research is recommended to identify potential gaps in the Botswana health system and similar settings.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02538952\">NCT02538952<\/jats:ext-link>. Retrospectively registered on 2 September 2015.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12879-019-4697-5","type":"journal-article","created":{"date-parts":[[2019,12,16]],"date-time":"2019-12-16T20:03:48Z","timestamp":1576526628000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Tuberculosis treatment outcomes among people living with HIV diagnosed using Xpert MTB\/RIF versus sputum-smear microscopy in Botswana: a stepped-wedge cluster randomised trial"],"prefix":"10.1186","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1848-7307","authenticated-orcid":false,"given":"Tefera","family":"Agizew","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Violet","family":"Chihota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sambayawo","family":"Nyirenda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zegabriel","family":"Tedla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew F.","family":"Auld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Unami","family":"Mathebula","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anikie","family":"Mathoma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosanna","family":"Boyd","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anand","family":"Date","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherri L.","family":"Pals","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phenyo","family":"Lekone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alyssa","family":"Finlay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,12,16]]},"reference":[{"issue":"11","key":"4697_CR1","doi-asserted-by":"publisher","first-page":"1005","DOI":"10.1056\/NEJMoa0907847","volume":"363","author":"C Boehme","year":"2010","unstructured":"Boehme C, Nabeta P, Hillemann D, Nicol P, Shenai S, Krapp F, et al. 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Written informed consent was obtained from adults (<u>><\/u>\u200918\u2009years old), assent was obtained from those aged 7\u201317\u2009years old in addition to written informed consent obtained from a parent or guardian for participants under 18\u2009years old.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1058"}}