Primary Outcome Measures:
- GenoType Direct line probe assay result (MTB-positive or negative) and conventional mycobacterial culture assay result (MTB-positive or negative) on direct sputum samples [ Time Frame: Throughout study ]
Secondary Outcome Measures:
- GenoType Direct line probe assay results on direct sputum samples [ Time Frame: Throughout study ]
- GenoType MTBDR Plus line probe assay results on cultured and direct sputum samples [ Time Frame: Throughout study ]
- Identified strains of drug resistant MTB [ Time Frame: Throughout study ]
- AFB smear with ZN staining results [ Time Frame: Throughout study ]
- AFB smear as evaluated with fluorescent microscopy results [ Time Frame: Throughout study ]
- MTB culture results (including speciation and, if indicated, drug susceptibility) [ Time Frame: Throughout study ]
- MTB blood culture results [ Time Frame: Throughout study ]
- Follow up clinical assessment of MTB disease status [ Time Frame: Throughout study ]
Early diagnosis of tuberculosis (TB) is of particular importance in HIV-infected individuals, as a delay of therapy can be devastating in those with compromised immune systems. Diagnosis of TB in HIV can be a particular challenge, however, because 24-61% of HIV co-infected individuals with pulmonary TB are smear-negative. Conventional solid media-based culture can take 6 weeks or longer for mycobacterial growth, and may not be available at all in many settings. The purpose of this study is to determine whether new tests for identifying TB and resistance to TB drugs are as effective as current tests and if these new tests can provide accurate results faster than the current method of testing for TB and drug resistance.
This trial will enroll HIV-infected individuals who are suspected to be co-infected with TB. Participants may be in this trial for up to nine months, depending on their test results. During the study, participants will provide one or two sputum samples, have a chest x-ray, and may have blood collected.
