TB fast track: effect of a point-of-care TB test-and-treat algorithm on early mortality in people with HIV accessing ART

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Treatment for HIV (antiretroviral therapy, or ART), has greatly reduced death rates among people with HIV worldwide. However in low-resource settings, death rates continue to be high even for people taking ART, particularly in the first few months on treatment. Tuberculosis (TB) is the most important cause of these early deaths, and people who are due to start ART are recommended to be screened for TB first. However, TB is hard to diagnose because the tests which are most widely available do not work well for people with HIV. As a result, people with HIV may have to go through lots of tests for TB, which delays the start of TB treatment; it also delays the start of ART. Both of these delays increase the risk that the patient dies. We propose a study to try to reduce this high death rate. In 20 primary care clinics in South Africa, we will enrol people with advanced HIV who have come to start ART to our study. In 10 of the clinics (intervention), selected at random, we will use simple, inexpensive tests (a new urine test for TB, weight and height, and a blood test for anaemia) which can be done on site with immediate results, to identify those patients who are at highest risk of having TB, and of dying early. People who are high risk will start TB treatment straight away, then ART as soon as possible afterwards; people who are low TB risk will start ART straight away. People with medium TB risk will be given antibiotics while a chest X-ray and sputum (spit) test for TB are done, and will come back after a week to decide if they should start TB treatment followed by ART, or just start ART. At the other 10 (control) clinics, patients will be looked after in the normal way, following national guidelines. We will follow all patients up for 6 months. We will compare the death rate at 6 months in the 10 intervention clinics, using our new approach, to death rates in the 10 control clinics, using the routine approach. If our new approach reduces the death rate, clinics throughout low resource settings could use this low-cost strategy to save lives among people with HIV.