Evaluation of a point-of-care tuberculosis test-and-treat algorithm on early mortality in people with HIV accessing antiretroviral therapy TB Fast Track study: study protocol for a cluster randomised controlled trialReportar como inadecuado




Evaluation of a point-of-care tuberculosis test-and-treat algorithm on early mortality in people with HIV accessing antiretroviral therapy TB Fast Track study: study protocol for a cluster randomised controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 16:125

First Online: 28 March 2015Received: 21 November 2014Accepted: 13 March 2015DOI: 10.1186-s13063-015-0650-0

Cite this article as: Fielding, K.L., Charalambous, S., Hoffmann, C.J. et al. Trials 2015 16: 125. doi:10.1186-s13063-015-0650-0

Abstract

BackgroundEarly mortality for HIV-positive people starting antiretroviral therapy ART remains high in resource-limited settings, with tuberculosis the most important cause. Existing rapid diagnostic tests for tuberculosis lack sensitivity among HIV-positive people, and consequently, tuberculosis treatment is either delayed or started empirically without bacteriological confirmation. We developed a management algorithm for ambulatory HIV-positive people, based on body mass index and point-of-care tests for haemoglobin and urine lipoarabinomannan LAM, to identify those at high risk of tuberculosis and mortality. We designed a clinical trial to test whether implementation of this algorithm reduces six-month mortality among HIV-positive people with advanced immunosuppression.

Methods-designThe TB Fast Track study is an open, pragmatic, cluster randomised superiority trial, with 24 primary health clinics randomised to implement the intervention or standard of care. Adults aged ≥18 years with a CD4 count of 150 cells-μL or less, who have not received any tuberculosis treatment in the last three months, or ART in the last six months, are eligible. In intervention clinics, the study algorithm is used to classify individuals as at high, medium or low probability of tuberculosis. Those classified as high probability start tuberculosis treatment immediately, followed by ART after two weeks. Medium-probability patients follow the South African guidelines for test-negative tuberculosis and are reviewed within a week, to be re-categorised as low or high probability. Low-probability patients start ART as soon as possible. The primary outcome is all-cause mortality at six months. Secondary outcomes include severe morbidity, time to ART start and cost-effectiveness.

DiscussionThis trial will test whether a primary care-friendly management algorithm will enable nurses to identify HIV-positive patients at the highest risk of tuberculosis, to facilitate prompt treatment and reduce early mortality. There remains an urgent need for better diagnostic tests for tuberculosis, especially for people with advanced HIV disease, which may render empirical treatment unnecessary.

Trial registrationThis trial was registered with Current Controlled Trials identifier: ISRCTN35344604 on 12 September 2012.

KeywordsTuberculosis HIV infections Pragmatic clinic trials Mortality Treatment AbbreviationsARTAntiretroviral therapy

BMIBody mass index

CXRChest radiograph

DALYDisability-adjusted life year

DMCData monitoring committee

LAMLipoarabinomannan

TSCTrial steering committee

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Autor: Katherine L Fielding - Salome Charalambous - Christopher J Hoffmann - Suzanne Johnson - Mpho Tlali - Susan E Dorman - Ann

Fuente: https://link.springer.com/







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