Observational Study of Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

• Effectiveness in creating a standard diagnostic evaluation for identification of participants with active pulmonary TB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

• Prevalence of TB in symptomatic and asymptomatic individuals [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Rates of TB drug resistance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Feasibility and incremental benefits of diagnostic and screening evaluations over a range of CD4 cell counts [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Value of oral candidiasis as a predictor of TB [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Significance of investigational serologic assay when added to sputum acid-fast bacilli (AFB) smears when identifying participants with active TB compared to AFB smears alone [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Storage of samples for future diagnostic and pathogenesis studies of mycobacterial, virologic, and immunologic factors [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

Well developed TB diagnostic testing, contact tracing, and treatment programs are key parts of the public health and health care infrastructure in many countries where HIV infection has resulted in a 3- to 10-fold increase in clinical TB, accompanied by increasing HIV prevalence. The primary purpose of this study is to construct a standardized diagnostic evaluation (SDE) for TB that provides an increase in identification of participants with active pulmonary TB, without sacrificing specificity.

This observational study will include participants who are HIV-infected and TB-uninfected and not receiving ARV therapy. The duration of this trial will last between 1 and 14 days. Screening and study entry may occur at the same visit. All evaluations must be performed within 14 days after the participant is registered. Medical and medication history, physical exam, oral examination and swab, chest x-ray, sputum and blood collection, and documentation of PPD/TST (if available) will occur within this 14-day period.