Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial

ABSTRACT OBJECTIVE: To verify the effectiveness of screening for tuberculosis (TB) on all-cause mortality and tuberculosis cases in newly diagnosed HIV-infected patients through a clinical algorithm based on recommendations of the World Health Organization. METHODS: From March 2014 to April 2016,...

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Main Authors: Marcela Lopes Santos, Joanna d’Arc Lyra Batista, Cynthia Braga, Adriana Paula da Silva, Magda Maruza, Wayner Vieira Souza, Maria Rosimery de Carvalho, Noemia Teixeira de Siqueira-Filha, Maria de Fátima Pessoa Militão de Albuquerque
Format: Article
Language:English
Published: Universidade de São Paulo 2021-07-01
Series:Revista de Saúde Pública
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102021000100237&tlng=en
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author Marcela Lopes Santos
Joanna d’Arc Lyra Batista
Cynthia Braga
Adriana Paula da Silva
Magda Maruza
Wayner Vieira Souza
Maria Rosimery de Carvalho
Noemia Teixeira de Siqueira-Filha
Maria de Fátima Pessoa Militão de Albuquerque
author_facet Marcela Lopes Santos
Joanna d’Arc Lyra Batista
Cynthia Braga
Adriana Paula da Silva
Magda Maruza
Wayner Vieira Souza
Maria Rosimery de Carvalho
Noemia Teixeira de Siqueira-Filha
Maria de Fátima Pessoa Militão de Albuquerque
author_sort Marcela Lopes Santos
collection DOAJ
description ABSTRACT OBJECTIVE: To verify the effectiveness of screening for tuberculosis (TB) on all-cause mortality and tuberculosis cases in newly diagnosed HIV-infected patients through a clinical algorithm based on recommendations of the World Health Organization. METHODS: From March 2014 to April 2016, a pragmatic randomized clinical trial was conducted with newly diagnosed and TB-free HIV-infected adults undergoing antiretroviral therapy for up to one month at a major tertiary hospital for HIV in the state of Pernambuco, Brazil. Participants were randomized into intervention and control groups using an automatically-generated random list, and followed-up for at least 6 months. The intervention group was screened for TB at hospital admission and at every follow-up visit through a series of questions addressing TB-related symptoms (cough, fever, night sweating, and weight loss). Patients presenting with any of these symptoms were referred to a pulmonologist and underwent sputum smear microscopy, sputum culture, and rapid molecular testing (GeneXpert). When at least one test result came back positive, TB treatment was initiated. In turn, if patients tested negative but presented with severe clinal symptoms, TB preventive treatment was initiated. Screening for TB was not performed systematically in the control group. The primary outcome assessed in this study was death from all causes, and secondary outcomes included sensitivity and specificity of this screening test, as well as its detection time. RESULTS: This study evaluated 581 patients, 377 in the intervention group (64.9%) and 204 in the control group (35.1%). In total, 36 patients died during the follow-up period. Of these, 26 (6.9%) were from the intervention group, reaching a cumulative mortality coefficient of 69 per 1,000 inhabitants, and 10 (4.9%) from the control group (p = 0.341), with a cumulative mortality coefficient of 49 per 1,000 inhabitants (p = 0.341).
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spelling doaj.art-3ddc55b03e66440496154414924164732022-12-21T19:22:46ZengUniversidade de São PauloRevista de Saúde Pública1518-87872021-07-015510.11606/s1518-8787.2021055002936Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trialMarcela Lopes Santoshttps://orcid.org/0000-0002-1283-7962Joanna d’Arc Lyra Batistahttps://orcid.org/0000-0002-3703-2845Cynthia Bragahttps://orcid.org/0000-0002-7862-6455Adriana Paula da Silvahttps://orcid.org/0000-0002-2803-6326Magda Maruzahttps://orcid.org/0000-0002-3326-8885Wayner Vieira Souzahttps://orcid.org/0000-0002-0939-9332Maria Rosimery de Carvalhohttps://orcid.org/0000-0002-9588-1204Noemia Teixeira de Siqueira-Filhahttps://orcid.org/0000-0003-0730-8561Maria de Fátima Pessoa Militão de Albuquerquehttps://orcid.org/0000-0002-4999-4160ABSTRACT OBJECTIVE: To verify the effectiveness of screening for tuberculosis (TB) on all-cause mortality and tuberculosis cases in newly diagnosed HIV-infected patients through a clinical algorithm based on recommendations of the World Health Organization. METHODS: From March 2014 to April 2016, a pragmatic randomized clinical trial was conducted with newly diagnosed and TB-free HIV-infected adults undergoing antiretroviral therapy for up to one month at a major tertiary hospital for HIV in the state of Pernambuco, Brazil. Participants were randomized into intervention and control groups using an automatically-generated random list, and followed-up for at least 6 months. The intervention group was screened for TB at hospital admission and at every follow-up visit through a series of questions addressing TB-related symptoms (cough, fever, night sweating, and weight loss). Patients presenting with any of these symptoms were referred to a pulmonologist and underwent sputum smear microscopy, sputum culture, and rapid molecular testing (GeneXpert). When at least one test result came back positive, TB treatment was initiated. In turn, if patients tested negative but presented with severe clinal symptoms, TB preventive treatment was initiated. Screening for TB was not performed systematically in the control group. The primary outcome assessed in this study was death from all causes, and secondary outcomes included sensitivity and specificity of this screening test, as well as its detection time. RESULTS: This study evaluated 581 patients, 377 in the intervention group (64.9%) and 204 in the control group (35.1%). In total, 36 patients died during the follow-up period. Of these, 26 (6.9%) were from the intervention group, reaching a cumulative mortality coefficient of 69 per 1,000 inhabitants, and 10 (4.9%) from the control group (p = 0.341), with a cumulative mortality coefficient of 49 per 1,000 inhabitants (p = 0.341).http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102021000100237&tlng=enHIV InfectionsTuberculosis, diagnosisMass ScreeningClinical Trial
spellingShingle Marcela Lopes Santos
Joanna d’Arc Lyra Batista
Cynthia Braga
Adriana Paula da Silva
Magda Maruza
Wayner Vieira Souza
Maria Rosimery de Carvalho
Noemia Teixeira de Siqueira-Filha
Maria de Fátima Pessoa Militão de Albuquerque
Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial
Revista de Saúde Pública
HIV Infections
Tuberculosis, diagnosis
Mass Screening
Clinical Trial
title Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial
title_full Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial
title_fullStr Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial
title_full_unstemmed Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial
title_short Effectiveness of screening for tuberculosis in HIV: a pragmatic clinical trial
title_sort effectiveness of screening for tuberculosis in hiv a pragmatic clinical trial
topic HIV Infections
Tuberculosis, diagnosis
Mass Screening
Clinical Trial
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102021000100237&tlng=en
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