About the PROTID Project

This comprehensive project addresses a key EDCTP prevention priority area, namely TB and comorbidities.

We will perform the first randomized controlled trial globally to evaluate the efficacy and impact of preventive treatment of latent tuberculosis infection (LTBI) in people living with diabetes.

We will randomize 3000 people with diabetes and LTBI in Tanzania and Uganda to a 12-week course of rifapentine and isoniazid preventive therapy or placebo, with cumulative incidence of TB disease over at least 24-months follow-up as primary endpoint.

1000 people with diabetes but without evidence of LTBI will be followed in parallel to confirm whether their incidence of TB is too low to warrant preventive treatment.

In addition, we plan to evaluate optimal ways to screen people with DM for LTBI and TB; address gaps in prevention and therapeutic management of combined TB and DM; and estimate the population impact and cost-effectiveness of treatment of LTBI in people living with DM

Tuberculosis – from latent infection to active disease

An estimated one quarter of the world’s population has latent tuberculosis infection (LTBI), of whom 5-10% will go on to develop TB disease at some stage. Screening and preventive treatment of LTBI is considered essential for global TB control. Children who have been in contact with a highly infectious TB case, and people with HIV have already been targeted for preventive treatment of LTBI. With short and effective treatment regimens available, the clear direction for global TB control is to expand preventive treatment to other high-risk groups.


People with diabetes as a risk group for tuberculosis

People with diabetes are an estimated 3.7 times more likely to develop TB than those without diabetes, and this risk is higher with poorly controlled diabetes. It is estimated that DM now accounts for >10% of TB globally, and this will increase significantly in the coming decades due to the dramatic rise in type 2 diabetes in TB endemic settings. Diabetes not only increases someone’s risk of developing TB disease, but is also associated with more severe TB disease, TB treatment failure, recurrent TB disease and death. As such, screening and management of LTBI in people living with DM will likely yield substantial health gains and contribute to global TB control.

The PROTID consortium


PROTID will benefit from the experience of the
collaborators to deliver multi-national clinical trials
in accordance with International Good Clinical Practice
(GCP) guidelines.









Three members of the PROTID consortium (Radboudumc (the Netherlands), St George’s, University of London (SGUL, UK) and University of Otago (UoO, New Zealand) were part of the successful TANDEM (‘Tuberculosis and Diabetes Mellitus’) consortium, funded by the European Union’s Seventh Framework Programme (FP7/2007–2013).

The PROTID clinical trial sites (Makerere University (Uganda), Uganda Martyrs Hospital Lubaga (Uganda), NIMR-Mbeya Medical Research Centre (NIMR-MMRC, Tanzania), and Kilimanjaro Christian Medical Centre (KCMC) have extensive clinical trial experience with multi-national multi-center trials, such as priMe, RaPaed TB, TB Reach, APRIORI, VITA, REMox, PanACEA MAMS, and SimpliciTB.

The consortium Executive Group will be lead by the Radboud UMC (the Netherlands), and the role of trial Sponsor will be assumed by NIMR Mbeya Medical Research Center (NIMR-MMRC, Tanzania).

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