Screening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group Protocol A5253
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/mm3. 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.
Keywords: HIV infection; diagnostics; sensitivity; specificity; tuberculosis
Document Type: Research Article
Affiliations: 1: University of Nebraska Medical Center, Omaha, Nebraska, USA 2: Harvard School of Public Health, Boston, Massachusetts, USA 3: National AIDS Research Institute, Pune, India 4: Centers for Disease Control and Prevention, Atlanta, Georgia, USA 5: University of Pennsylvania, Philadelphia, Pennsylvania, USA 6: Albert Einstein College of Medicine, Bronx, New York, USA 7: Johns Hopkins University, Baltimore, Maryland, USA 8: Instituto de Pesquisa Clinica Evandro, Rio de Janeiro, Rio de Janeiro, Brazil 9: Scottish Livingstone Hospital, Molepole, Botswana 10: Princess Marina Hospital, Gaborone, Botswana 11: Center for the AIDS Programme of Research in South Africa, Durban, South Africa 12: University of KwaZulu-Natal, Durban, South Africa 13: AIDS Clinical Trials Group Operations Center, Silver Spring, Maryland, USA 14: University of California San Francisco, San Francisco, California, USA 15: Montgomery County Health Department, Silver Spring, Maryland, USA 16: Stanford University Medical Center, Stanford, California, USA
Publication date: 01 April 2013
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