. 2020 Apr 21;15(1):24.

doi: 10.1186/s13012-020-00988-y.

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^{1

2}, Talemwa Nalugwa³, Katherine Farr⁴, Mariam Nantale³, Denis Oyuku³, Annet Nakaweesa³, Johnson Musinguzi³, Moksha Vangala^{1

2}, Priya B Shete^{1

2

3}, Austin Tucker⁵, Olivia Ferguson⁵, Katherine Fielding⁶, Hojoon Sohn⁵, David Dowdy^{3

5}, David A J Moore⁷, J Lucian Davis^{3

8

9}, Sara L Ackerman¹⁰, Margaret A Handley¹¹, Achilles Katamba^{3

12}, Adithya Cattamanchi^{13

14

15}

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
² Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
³ Uganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
⁴ Implementation Science Program, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁶ Faculty of Epidemiology and Population Health and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
⁷ Faculty of Infectious and Tropical Diseases and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
⁸ Department of Epidemiology of Microbial Diseases and Center for Methods in Implementation and Prevention Sciences, Yale School of Public Health, New Haven, CT, USA.
⁹ Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, CT, USA.
¹⁰ Department of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
¹² School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
¹³ Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA. adithya.cattamanchi@ucsf.edu.
¹⁴ Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA. adithya.cattamanchi@ucsf.edu.
¹⁵ Uganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda. adithya.cattamanchi@ucsf.edu.

PMID: 32316993
PMCID: PMC7171793
DOI: 10.1186/s13012-020-00988-y

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 et al. Implement Sci. 2020.

. 2020 Apr 21;15(1):24.

doi: 10.1186/s13012-020-00988-y.

Authors

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.
² Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.
³ Uganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda.
⁴ Implementation Science Program, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁵ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁶ Faculty of Epidemiology and Population Health and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
⁷ Faculty of Infectious and Tropical Diseases and TB Centre, London School of Hygiene and Tropical Medicine, London, UK.
⁸ Department of Epidemiology of Microbial Diseases and Center for Methods in Implementation and Prevention Sciences, Yale School of Public Health, New Haven, CT, USA.
⁹ Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, CT, USA.
¹⁰ Department of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
¹¹ Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
¹² School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
¹³ Division of Pulmonary and Critical Care Medicine, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA. adithya.cattamanchi@ucsf.edu.
¹⁴ Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA. adithya.cattamanchi@ucsf.edu.
¹⁵ Uganda Tuberculosis Implementation Research Consortium (U-TIRC), Kampala, Uganda. adithya.cattamanchi@ucsf.edu.

PMID: 32316993
PMCID: PMC7171793
DOI: 10.1186/s13012-020-00988-y

Abstract

Background: Delays 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.

Methods: The 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 registration: US National Institutes of Health's ClinicalTrials.gov, NCT03044158. Registered 06 February 2017. Pan African Clinical Trials Registry, PACTR201610001763265. Registered 03 September 2016.

Keywords: Cluster randomized trial; Effectiveness-implementation design; Pragmatic trial; Tuberculosis; Xpert MTB/RIF.

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Conflict of interest statement

The authors declare no competing interests.

Figures

**Fig. 1**
Theory-informed barrier assessment and design of intervention strategy

**Fig. 2**
Site selection and enrollment for XPEL TB trial

See this image and copyright information in PMC

References

1. Keeler E, Perkins MD, Small P, Hanson C, Reed S, Cunningham J, et al. Reducing the global burden of tuberculosis: the contribution of improved diagnostics. Nature. 2006;444(Suppl 1):49–57. doi: 10.1038/nature05446. - DOI - PubMed
1. World Health Organization. Monitoring of Xpert MTB/RIF roll-out. 2016. Available from: https://www.who.int/tb/areas-of-work/laboratory/mtb-rif-rollout/en/. [Accessed 05 Mar 2020].
1. The Foundation for Innovative New Diagnostics. GeneXpert. Available from: https://www.finddx.org/pricing/genexpert/. [Accessed 05 Mar 2020].
1. Cazabon D, Pande T, Kik S, Van Gemert W, Sohn H, Denkinger C, et al. Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: a trend analysis from 2014 - 2016. Gates Open Res. 2018;2:35. doi: 10.12688/gatesopenres.12842.1. - DOI - PMC - PubMed
1. Farr K, Nalugwa T, Ojok C, Nantale M, Nabwire S, Oyuku D, et al. Quality of care for patients evaluated for tuberculosis in the context of Xpert MTB/RIF scale-up. J Clin Tuberc Other Mycobact Dis. 2019;15:100099. doi: 10.1016/j.jctube.2019.100099. - DOI - PMC - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical