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
Department of Clinical Research, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom; Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, South Africa; Department of Infectious Disease, Imperial College, London, United Kingdom; Academic Unit of Primary Care and Population Sciences and Academic Unit of Social Sciences, University of Southampton, Southampton, United Kingdom; Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa; UCL Institute of Child Health, London, United Kingdom
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.
adult; article; binomial distribution; cluster analysis; comparative study; controlled study; health center; high risk patient; human; Human immunodeficiency virus infection; lung tuberculosis; molecular diagnostics; mortality; multidrug resistant tuberculosis; Mycobacterium tuberculosis; outcome assessment; randomized controlled trial; rural area; South Africa; sputum culture; treatment duration; univariate analysis; Ambulatory Care Facilities; Antitubercular Agents; Bacteriological Techniques; Clinical Protocols; Coinfection; HIV Infections; Humans; Laboratories; Logistic Models; Molecular Diagnostic Techniques; Mycobacterium tuberculosis; Point-of-Care Systems; Predictive Value of Tests; Primary Health Care; Research Design; Risk Assessment; Risk Factors; Rural Health Services; South Africa; Sputum; Time Factors; Tuberculosis, Multidrug-Resistant; Tuberculosis, Pulmonary
090999/Z/09/Z, Wellcome Trust