Screening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group Protocol A5253.

TitleScreening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group Protocol A5253.
Publication TypeJournal Article
Year of Publication2013
AuthorsSwindells S, Komarow L, Tripathy S, Cain KP, MacGregor RR, Achkar JM, Gupta A, Veloso VG, Asmelash A, Omoz-Oarhe AE, Gengiah S, Lalloo U, Allen R, Shiboski C, Andersen J, Qasba SS, Katzenstein DK
Corporate AuthorsAIDS Clinical Trials Group 5253 Study Team
JournalInt J Tuberc Lung Dis
Date Published2013 Apr
KeywordsAdult, Africa South of the Sahara, Algorithms, Bacteriological Techniques, Brazil, CD4 Lymphocyte Count, Clinical Protocols, Coinfection, Cough, Cross-Sectional Studies, Female, Fever, HIV Infections, Humans, India, Male, Mass Screening, Microscopy, Fluorescence, Mycobacterium tuberculosis, Peru, Predictive Value of Tests, Prevalence, Prospective Studies, Radiography, Thoracic, Sputum, Standard of Care, Sweating, Tuberculosis, Pulmonary, Weight Loss

BACKGROUND: Improved tuberculosis (TB) screening is urgently needed for human immunodeficiency virus (HIV) infected patients.

METHODS: An observational, multi-country, cross-sectional study of HIV-infected patients to compare a standardized diagnostic evaluation (SDE) for TB with standard of care (SOC). SOC evaluations included TB symptom review (current cough, fever, night sweats and/or weight loss), sputum Ziehl-Neelsen staining and chest radiography. SDE screening added extended clinical signs and symptoms and fluorescent microscopy (FM). All participants underwent all evaluations. Mycobacterium tuberculosis on sputum culture was the primary outcome.

RESULTS: A total of 801 participants were enrolled from Botswana, Malawi, South Africa, Zimbabwe, India, Peru and Brazil. The median age was 33 years; 37% were male, and median CD4 count was 275 cells/mm(3). Thirty-one participants (4%) had a positive culture on Löwenstein-Jensen media and 54 (8%) on MGIT. All but one positive culture came from sub-Saharan Africa, where the prevalence of TB was 54/445 (12%). SOC screening had 54% sensitivity (95%CI 40-67) and 76% specificity (95%CI 72-80). Positive and negative predictive values were respectively 24% and 92%. No elements of the SDE improved the predictive values of SOC.

CONCLUSIONS: Symptom-based screening with smear microscopy was insufficiently sensitive. More sensitive diagnostic testing is required for HIV-infected patients.

Alternate JournalInt. J. Tuberc. Lung Dis.
PubMed ID23485388
PubMed Central IDPMC3923622
Grant ListP30 AI051519 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States