The STAMP Study

 Context

The brunt of the global AIDS epidemic has been felt in sub-Saharan Africa, with 24.7 million people living with HIV and accounting for 71% of the people living with HIV worldwide. In 2013, there were an estimated 1.1 million deaths due to AIDS in sub-Saharan Africa.

Tuberculosis (TB) is the leading cause of AIDS-related illness and deaths worldwide. 75% of TB cases occur in sub-Saharan Africa. Studies have shown that 30-67% of HIV+ adult patients who die in hospitals are found to have TB. Most of these cases were neither clinically suspected nor diagnosed before death, illustrating a stark failure of current approaches to properly diagnose patients.

The current standard for TB detection in Malawi is a laboratory test called Xpert MTB/RIF. This laboratory test requires a patient sputum sample, and it often takes a few days to return the results to the patient. Several studies have shown fewer than 50% of patients could produce sputum samples when requested.  Furthermore, TB often involves organs other than the lungs and therefore is not always caught using the Xpert test. A new bedside urine-based test has shown promise in increasing the detection of TB. This test, called TB-LAM, can diagnose TB within 30 minutes. While the use of this test has shown increased TB detection, there is no evidence yet that it will reduce HIV-TB mortality. In addition, the cost-effectiveness of this new diagnostic tool has not been shown.

 Aim

To determine whether adding urine testing (using the TB-LAM and Xpert tests) to the routine sputum Xpert test reduces mortality and is cost-effective in TB-HIV co-infected patients.