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. 2013 Lessells et al.; licensee BioMed Central Ltd.
R.J., L., G.S., C., N., M., M.P., N., M.-L., N., & P., G.-F. (2013). 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. Trials, 14(1). https://doi.org/10.1186/1745-6215-14-170 LK - http://findit.library.jhu.edu/resolve?sid=EMBASE&issn=17456215&id=doi:10.1186%2F1745-6215-14-170&atitle=Impact+of+a+novel+molecular+TB+diagnostic+system+in+patients+at+high+risk+of+TB+mortality+in+rural+South+Africa+%28Uchwepheshe%29%3A+Study+protocol+for+a+cluster+randomised+trial&stitle=Trials&title=Trials&volume=14&issue=1&spage=&epage=&aulast=Lessells&aufirst=Richard+J.&auinit=R.J.&aufull=Lessells+R.J.&coden=&isbn=&pages=-&date=2013&auinit1=R&auinitm=J