Abstract
ABSTRACTOBJECTIVE: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).
Highlights
The synergy between the human immunodeficiency virus (HIV) and Mycobacterium tuberculosis has been a major threat for public health due to its magnitude and the high mortality rates from tuberculosis (TB) among people living with HIV (PLHIV)
Among the 663 eligible patients admitted to the Correia Picanço Hospital (CPH) during the study period, 82 (12.4%) were excluded – 72 (87.8%) of whom refused to participate and 10 (12.2%) who were excluded for presenting negative HIV test results (n = 5) or for being incarcerated (n = 5)
The screening method reached a high negative predictive value (NPV) – an important factor for clinical care given that HIV-infected patients who report no cough, fever, night sweats, and weight loss most likely do not present with TB (97%)
Summary
The synergy between the human immunodeficiency virus (HIV) and Mycobacterium tuberculosis has been a major threat for public health due to its magnitude and the high mortality rates from tuberculosis (TB) among people living with HIV (PLHIV). Recent studies have presented inconclusive results depending on the region where they are performed[9,10,11,12,13,14,15,16,17]. In this sense, our study aims is to verify the effectiveness of a screening test for TB performed through a clinical algorithm among PLHIV in the routine of a specialized health service in HIV, verifying its impact on all-cause mortality
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