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
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
Trials 2013, 14:170 doi:10.1186/1745-6215-14-170Published: 12 June 2013
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.
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.
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.
Current Controlled Trials ISRCTN18642314; South African National Clinical Trials Registry DOH-27-0711-3568.