Evidence map›Paper›PMID 32316993›Full record

ArticleImplementation science : IS2020

Study protocol: a cluster randomized trial to evaluate the effectiveness and implementation of onsite GeneXpert testing at community health centers in Uganda (XPEL-TB).

Tania F Reza, Talemwa Nalugwa, Katherine Farr, Mariam Nantale, Denis Oyuku, Annet Nakaweesa, Johnson Musinguzi, Moksha Vangala, Priya B Shete, Austin Tucker and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Implementation science : IS, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03044158 (GeneXpert Performance Evaluation for Linkage to Tuberculosis Care), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 28% 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.

NCT03044158 nacompletednot on this map

GeneXpert Performance Evaluation for Linkage to Tuberculosis Care: The XPEL-TB Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2018 to 2022Enrolled10,644ConditionsTuberculosis, Pulmonary, Rifampicin Resistant TuberculosisArmsGeneXpert I, Process re-design, Performance Feedback
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
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  14. Costs along the TB diagnostic pathway in Uganda.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021
    Article
  15. Impact of shelter-in-place on TB case notifications and mortality during the COVID-19 pandemic.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2020
    Article
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

20 authors at 6 institutions in 3 countries.

Tania F RezaDivision of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Talemwa NalugwaUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Katherine FarrImplementation Science Program, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Mariam NantaleUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Denis OyukuUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Annet NakaweesaUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Johnson MusinguziUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Moksha VangalaDivision of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Priya B SheteDivision of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
Austin TuckerDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Olivia FergusonDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Katherine FieldingFaculty of Epidemiology and Population Health and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
Hojoon SohnDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
David DowdyUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
David A J MooreFaculty of Infectious and Tropical Diseases and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
J Lucian DavisUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Sara L AckermanDepartment of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
Margaret A HandleyDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Achilles KatambaUganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
Adithya CattamanchiDivision of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA. adithya.cattamanchi@ucsf.edu.
Johns Hopkins University · USUniversity of California, San Francisco · USLondon School of Hygiene & Tropical Medicine · GBMakerere University · UGSan Francisco General Hospital · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
SIngle-saMPLE tuberculosis evaluation to facilitate linkage to care: The SIMPLE TB trialR01HL130192 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CATTAMANCHI, ADITHYA · 2016 to 2020
$3.2M
Medical Research Council MR/R010161/1NCATS NIH HHS UL1 TR001863NHLBI NIH HHS 5R01HL130192NHLBI NIH HHS R01 HL130192
6 · The paper itself

Abstract

backgroundDelays in diagnosis and treatment of tuberculosis (TB) remain common in high-burden countries. To improve case detection, substantial investments have been made to scale-up Xpert MTB/RIF (Xpert), a cartridge-based nucleic acid amplification test that can detect TB within 2 hours, as a replacement for sputum smear microscopy. However, the optimal strategy for implementation of Xpert testing remains unclear.

methodsThe Xpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial uses an ultra-pragmatic, hybrid type II effectiveness-implementation design to assess the effectiveness and implementation of a streamlined strategy for delivery of Xpert testing in real-world settings. Twenty health centers with TB microscopy units were selected to participate in the trial, with ten health centers randomized to the intervention strategy (onsite molecular testing using GeneXpert Edge, process redesign to facilitate same-day TB diagnosis and treatment, and performance feedback) or routine care (onsite sputum smear microscopy plus referral of sputum samples to Xpert testing sites). The primary outcome is the number of patients with microbiologically confirmed TB who were initiated on treatment within 14 days of presentation to the health center, which reflects successful completion of the TB diagnostic evaluation process. Secondary outcomes include health outcomes (6-month vital status), as well as measures of the reach, adoption, and implementation of the intervention strategy. DISCUSSION: The design elements and implementation approach for the XPEL-TB trial were intentionally selected to minimize disruptions to routine care procedures, with the goal of limiting their influence on key primary and secondary outcomes. Trial findings may result in increased support and funding for rapid, onsite molecular testing as the standard-of-care for all patients being evaluated for TB.

trial registrationUS National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016.

Indexed as

Community Health CentersNucleic Acid Amplification TechniquesTuberculosisHumansPragmatic Clinical Trials as TopicReproducibility of ResultsResearch DesignSingle-Blind MethodSputumUgandaCluster randomized trialEffectiveness-implementation designPragmatic trialTuberculosisXpert MTB/RIF

Identifiers

PMID32316993
PMCPMC7171793
OpenAlexW3016755500

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.