Randomised Controlled Trial of Preventive Treatment of Latent Tuberculosis Infection in Patients with Diabetes Mellitus (PROTID2)

Diabetes Mellitus(DM) contributesto an estimated 11.3% of adult deaths worldwide. Approximately 1 in 10 adults globally are estimated to have DM and the prevalence will rise significantly over the coming decades, especially in sub-Saharan Africa. People with DM have a three-fold increased risk of developing TB, and two-fold higher risk of dying from TB or experiencing treatment failure or recurrent disease, further threatening global TB control. As such, the growing burden of DM alongside the continuing TB epidemic have huge health and socio- economic impact. PROTID performs the first randomized controlled trial (RCT) globally to evaluate efficacy, safety, costutility and population impact of preventive treatment of TB preventive therapy for people with DM. It also examines gaps in diagnosis and management of DM and DM-TB in Uganda and Tanzania. Our results will guide global policy on TB prevention and management in people with DM, and this can have large socio-economic impact. In Africa, this is highly relevant given the double burden of DM and TB. In Europe, our results will be highly relevant for migrants and people living in eastern Europe, as both groups have a high burden of DM, latent tuberculosis infection (LTBI) and TB disease. PROTID’s results so far, and other advancements in the field, have already set clear research priorities beyond PROTID. PROTID is very well-positioned to take these forward, with strengthened leadership and research capacity in PROTID’s African partners embedded in a global research network, and its accumulated data on the largest and most-well characterized longitudinal cohort on DM and TB globally.