META-TRIAL

The project aim is to identify a low-cost intervention for preventing and delaying the development of diabetes among HIV-infected persons on antiretroviral therapy (ART) in Africa.

The main objectives are:

1) In partnership between researchers, policy makers, health care providers and patient representatives, conduct a large phase III randomised double-blind trial of metformin versus placebo among HIV-infected persons with pre-diabetes in Africa.

2) Develop research capacity in clinical studies of diabetes, hypertension and other chronic conditions in HIV infection.

This will be the largest trial of its kind in Africa and it will generate evidence that will be of global relevance. In ancillary studies the project will compare diagnostic methods for diabetes in HIV-infected persons. These and various clinical data will be used to enhance capacity development opportunities.

Coordinated by the Liverpool School of Tropical Medicine (LSTM), the partnership is built on an ethos of openness and equality between researchers and non-researchers, and between African and European partners that includes the Tanzania Ministry of Health, the National Institute for Medical Research (NIMR), the Hindu Mandal Hospital, the Barcelona Institute for Global Health (ISGlobal), and the University of Bergen.

This trial is funded by the European & Developing Countries Clinical Trials (EDCTP) Partnership which aims to contribute to the reduction of the individual, social, and economic burden of poverty-related infectious diseases in sub-Saharan Africa.

This project (RIA2018CO-2513) is part of the EDCTP2 programme supported by the European Union