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Open Access Study protocol

Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial

Richard J Lessells12*, Graham S Cooke23, Nuala McGrath24, Mark P Nicol5, Marie-Louise Newell26 and Peter Godfrey-Faussett1

Author Affiliations

1 Department of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK

2 Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa

3 Department of Infectious Disease, Imperial College, London, UK

4 Academic Unit of Primary Care and Population Sciences and Academic Unit of Social Sciences, University of Southampton, Southampton, UK

5 Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa

6 UCL Institute of Child Health, London, UK

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Trials 2013, 14:170  doi:10.1186/1745-6215-14-170

Published: 12 June 2013

Abstract

Background

Tuberculosis control in sub-Saharan Africa has long been hampered by poor diagnostics and weak health systems. New molecular diagnostics, such as the Xpert® MTB/RIF assay, have the potential to improve patient outcomes. We present a cluster randomised trial designed to evaluate whether the positioning of this diagnostic system within the health system has an impact on important patient-level outcomes.

Methods/Design

This pragmatic cluster randomised clinical trial compared two positioning strategies for the Xpert MTB/RIF system: centralised laboratory versus primary health care clinic. The cluster (unit of randomisation) is a 2-week time block at the trial clinic. Adult pulmonary tuberculosis suspects with confirmed human immunodeficiency virus infection and/or at high risk of multidrug-resistant tuberculosis are enrolled from the primary health care clinic. The primary outcome measure is the proportion of culture-confirmed pulmonary tuberculosis cases initiated on appropriate treatment within 30 days of initial clinic visit. Univariate logistic regression will be performed as the primary analysis using generalised estimating equations with a binomial distribution function and a logit link.

Conclusion

Diagnostic research tends to focus only on performance of diagnostic tests rather than on patient-important outcomes. This trial has been designed to improve the quality of evidence around diagnostic strategies and to inform the scale-up of new tuberculosis diagnostics within public health systems in high-burden settings.

Trial registration

Current Controlled Trials ISRCTN18642314; South African National Clinical Trials Registry DOH-27-0711-3568.

Keywords:
Tuberculosis; Multidrug-resistant tuberculosis; HIV; Molecular diagnostics; Point-of-care systems; Clinical trial