HIV Infections Clinical Trial
Official title:
Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa, southeastern Asia, and Latin America in the coming decade. In these settings, Tuberculosis (TB) is an endemic infection in the population, and an estimated 30-60% of adults have been infected with TB, the leading opportunistic infection associated with HIV infection. The 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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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