SaDAPT - Same-Day ART initiation persons with HIV and Presumptive Tuberculosis

The SaDAPT (Same-Day ART in persons with HIV and Presumptive Tuberculosis) study, a randomized controlled clinical trial in Lesotho and Malawi, is investigating the hitherto unanswered question of when antiretroviral therapy in persons tested positive for HIV should be started when they simultaneously show symptoms of a possible TB infection.

Tuberculosis is the most common cause of death in people with HIV in Africa. The two diseases often occur together, not only because of their geographical distribution; an HIV infection increases the risk of contracting active TB many times over. The symptoms of TB, such as cough, fever or weight loss, are very unspecific.

If persons with HIV/TB co-infection are started on antiretroviral therapy without first starting TB treatment, this can lead to immune reconstitution syndrome (IRIS), which can be severe. Therefore, it is recommended that if TB is suspected, it should first be either ruled out or confirmed and TB treatment initiated before starting antiretroviral therapy for the HIV infection. In remote clinics in rural Africa, however, access to TB diagnostics is often difficult and ruling out/confirming it takes several days, as the sputum samples must first be collected and sent to a central laboratory. This often leads to unnecessary delays in treatment initiation and sometimes to patients not being able to afford another clinic visit and thus remaining without HIV treatment, which in turn can lead to HIV-associated complications and further HIV transmission.To date, there is no scientific evidence for this difficult balancing act and accordingly no clear treatment guidelines.

In consultation with the World Health Organisation (WHO), Swiss TPH scientists are now developing a study protocol to test whether it is clinically safe to start antiretroviral therapy in clinics with difficult access to TB diagnostics before TB is ruled out/diagnosed, thus reducing the risk of losing patients before therapy is started. The project is being carried out by a consortium consisting of Swiss TPH, SolidarMed Lesotho, Liverpool School of Tropical Medicine, London School of Hygiene and Tropical Medicine and Helse Nord Tuberculosis Initiative Malawi and financed by the Swiss National Science Foundation (SNSF).

Scientific and social context of the research project

In many severely affected countries, especially in southern Africa, HIV and TB prevent sustainable, successful economic development due to their massive impact on the health and life expectancy of the population. Drug treatment for both diseases is complex and lengthy, in the case of HIV even lifelong. At the same time, rapid and adequate drug treatment is not only crucial for the health and survival of the affected patients, but also for slowing down or preventing the spread of the diseases in the population. This study aims at contributing to the development of future guidelines to improve treatment strategies in low-income countries.