Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial

• Published in: BMC infectious diseases 2016-09, Vol.16 (1), p.501-501, Article 501
• Main Authors: Gupta-Wright, Ankur, Fielding, Katherine L, van Oosterhout, Joep J, Wilson, Douglas K, Corbett, Elizabeth L, Flach, Clare, Reddy, Krishna P, Walensky, Rochelle P, Peters, Jurgens A, Alufandika-Moyo, Melanie, Lawn, Stephen D
• Format: Article
• Language: English
• Subjects: Acquired Immunodeficiency Syndrome - complications; Acquired Immunodeficiency Syndrome - microbiology; Acquired Immunodeficiency Syndrome - mortality; Adult; AIDS-Related Opportunistic Infections - diagnosis; AIDS-Related Opportunistic Infections - urine; Antitubercular agents; Care and treatment; Clinical trials; Dosage and administration; HIV infection; HIV Infections - complications; HIV Infections - microbiology; Hospitalization; Humans; Infectious diseases; Influence; Isoniazid - therapeutic use; Malawi; Mass Screening; Patient outcomes; Randomized Controlled Trials as Topic - methods; South Africa; Sputum - microbiology; Study Protocol; Tuberculosis; Tuberculosis - diagnosis; Tuberculosis - prevention & control; Tuberculosis - urine; Urinalysis - methods
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/s12879-016-1837-z

HIV-associated tuberculosis (TB) co-infection remains an enormous burden to international public health. Post-mortem studies have highlighted the high proportion of HIV-positive adults admitted to hospital with TB. Determine TB-LAM and Xpert MTB/RIF assays can substantially increase diagnostic yield of TB within one day of hospital admission. However, it remains unclear if this approach can impact clinical outcomes. The STAMP trial aims to test the hypothesis that the implementation a urine-based screening strategy for TB can reduce all cause-mortality among HIV-positive patients admitted to hospital when compared to current, sputum-based screening. The trial is a pragmatic, individually randomised, multi-country (Malawi and South Africa) clinical trial with two study arms (1:1 recruitment). Unselected HIV-positive patients admitted to medical wards, irrespective of presentation, meeting the inclusion criteria and giving consent will be randomized to screening for TB using either: (i) 'standard of care'- testing of sputum using the Xpert MTB/RIF assay (Xpert) or (ii) 'intervention'- testing of sputum using Xpert and testing of urine using (a) Determine TB-LAM lateral-flow assay and (b) Xpert following concentration of urine by centrifugation. Patients will be excluded if they have received TB treatment in the previous 12 months, if they have received isoniazid preventive therapy in the last 6 months, if they are aged