PROTID annual meeting 2023 – project update
The PROTID (Preventive Treatment of Latent Tuberculosis Infection in people with Diabetes Mellitus) project addresses a key EDCTP prevention priority area, namely TB and comorbidities. In 2022 we initiated the first randomized controlled trial globally that evaluates the efficacy and impact of preventive treatment of latent tuberculosis infection (LTBI) in people living with diabetes. On 27-28 February the PROTID consortium came together for the first face-to-face meeting since the COVID-19 pandemic in Moshi, Tanzania.
PROTID aims to enrol ~6000 people living with diabetes in Tanzania and Uganda in a large descriptive cohort, of which 3000 people with diabetes and LTBI will be randomised to a 12-week course of rifapentine and isoniazid preventive therapy or placebo, with cumulative incidence of TB disease over 24 months’ follow-up as the 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.
So far, we have enrolled ~2000 participants in the diabetes cohort (of which ~50% LTBI positive), ~750 participants in the RCT, and another ~350 in the parallel cohort. We have also started collecting data on gaps in prevention and therapeutic management of combined TB and diabetes, as well as estimation of the population impact and cost-effectiveness of treatment of LTBI in people living with diabetes. The considerable cohort size enabled discussion of the first unique characteristics of the diabetes population in Sub-Saharan Africa (SSA) at this annual meeting. A framework for SSA PhD and MSc students has been successfully implemented, and also African leadership remains a continuous point of attention with half of the WPs being led by African PIs, as well as the RCT being led by NIMR-MMRC (Mbeya, Tanzania) as study sponsor.
At the annual meeting, the consortium discussed that irrespective of a steady recruitment pace throughout 2022/2023, we are lagging behind on our original project planning. We discussed alternative strategies for increasing recruitment rates at length. Potential strategies include opening of additional sites and slimming down supporting project activities. This is continuously balanced against overall project output and impact. Overall, the PROTID consortium convened in a highly inclusive atmosphere, and was determined to move forward in a positive direction.