Evidence map›Paper›PMID 31842773›Full record

Trial reportBMC infectious diseases2019

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.

Tefera Agizew, Violet Chihota, Sambayawo Nyirenda, Zegabriel Tedla, Andrew F Auld, Unami Mathebula, Anikie Mathoma, Rosanna Boyd, Anand Date, Sherri L Pals and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02538952 (Evaluating Performance, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons in Botswana During 2012-2013), which is not on this map. Cited by 9 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 4 pooled it
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02538952 phase4completednot on this map

Evaluating Performance, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons in Botswana During 2012-2013: The Xpert Package Rollout Evaluation Study (XPRES)

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2012 to 2017Enrolled18,696ConditionsTuberculosis, Human Immunodeficiency VirusArmsXpert device, Intensified TB Case Finding (ICF)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 4 syntheses or guidelines pooled it, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 4 countries.

Tefera AgizewCenters for Disease Control and Prevention, Gaborone, Botswana. tefersast@gmail.com.ORCID http://orcid.org/0000-0003-1848-7307
Violet ChihotaFaculty of Health Sciences, Department of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
Sambayawo NyirendaCenters for Disease Control and Prevention, Gaborone, Botswana.
Zegabriel TedlaCenters for Disease Control and Prevention, Gaborone, Botswana.
Andrew F AuldDivision of Global HIV and Tuberculosis, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Unami MathebulaCenters for Disease Control and Prevention, Gaborone, Botswana.
Anikie MathomaCenters for Disease Control and Prevention, Gaborone, Botswana.
Rosanna BoydCenters for Disease Control and Prevention, Gaborone, Botswana.
Anand DateDivision of Global HIV and Tuberculosis, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Sherri L PalsDivision of Global HIV and Tuberculosis, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Phenyo LekoneCenters for Disease Control and Prevention, Gaborone, Botswana.
Alyssa FinlayCenters for Disease Control and Prevention, Gaborone, Botswana.
Centers for Disease Control and Prevention · USUniversity of Botswana · BWUniversity of the Witwatersrand · ZA

Funding

This research has been supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention. Not Applicable
6 · The paper itself

Abstract

backgroundXpert® 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.

methodsPeople living with HIV (PLHIV) initiating antiretroviral therapy at 22 HIV clinics were enrolled and underwent systematic screening for TB (August 2012-November 2014). GeneXpert instruments were deployed following a stepped-wedge design at 13 centers from October 2012-June 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).

resultsAmong 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]: 4.70-17.48; p < 0.001) 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: 0.75-2.26; p = 0.268). Compared to smear, in Xpert arm median days from sputum collection to TB treatment was 6 days (interquartile range [IQR] 2-17 versus 22 days [IQR] 3-51), p = 0.005; 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: 1.01-3.96, p = 0.048). In smear arm empiric treatment was 68.4% (39/57) versus 48.7% (97/199), aOR, 2.28, 95% CI: 1.24-4.20, p = 0.011), compared to Xpert arm.

conclusionsTB 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.

trial registrationClinicalTrials.gov Identifier: NCT02538952. Retrospectively registered on 2 September 2015.

Indexed as

AdultBotswanaData AccuracyFemaleFollow-Up StudiesHIV InfectionsHumansLost to Follow-UpMaleMass ScreeningMicroscopyMycobacterium tuberculosisNucleic Acid Amplification TechniquesProspective StudiesSensitivity and SpecificitySputumOutcomeSmearTreatmentTuberculosisXpert MTB/RIF

Identifiers

PMID31842773
PMCPMC6915885
OpenAlexW2994745681

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.