Project description
Tackling diabetes in people living with HIV in Tanzania
Diabetes is a common and serious co-morbidity among people living with HIV, increasing their risk of complications and affecting their quality of life. Managing this dual health burden is challenging, especially in resource-limited settings. The COVID-19 pandemic complicated care by decentralising HIV services to community posts and impeding patient recruitment for research. In this context, the EU-funded META Trial project began in October 2021 in Dar es Salaam, Tanzania, to assess if metformin can prevent diabetes in HIV-positive individuals with pre-diabetes. This phase III placebo-controlled trial aims to enrol 2 100 participants and provide critical data by 2025, potentially informing global health strategies. Preliminary results show reductions in glucose levels and weight.
Objective
Diabetes is a common co-morbidity among people living with HIV. Since Oct 2021, we have been conducting a phase III randomised placebo-controlled trial of metformin among people living with HIV and pre-diabetes in Dar es Salaam, Tanzania (EDCTP RIA2018CO-2513). The aim is to test whether metformin can prevent progression to diabetes among people living with HIV. The primary endpoint is the time to diabetes.
We had planned to enrol 2100 participants, follow-up for 3 years, and finish at the end of Dec 2024. COVID-19 resulted in severe delays to regulatory review. HIV care was decentralised away from health facilities to community posts to reduce COVID-19 risk, which led to much slower recruitment.
We have now enrolled 1550 participants over the last 20 months. Less than 1% have been lost to follow-up. We will reach our target recruitment in Dec 2023 and will continue follow-up until Dec 2025. This will provide an average follow-up of 3 years per participant.
Analyses of aggregated data to date show that glucose levels and weight have fallen over first 12 months among the trial cohort. Thus, we believe that trial will answer the research question by continuing follow-up until Dec 2025. In 2026, we will disseminate the findings to stakeholders and to the international bodies.
We are collecting clinical, health economics, and qualitative data. The trial is being done as an equitable partnership between European and African researchers, and in partnership with Ministry of Health policy-makers and African patient representative bodies. We have good links with the African Centres for Disease Control, World Health Organisation (WHO-AFRO and Geneva offices), and Global Fund in order to inform policy considerations. Merck Pharma has provided medicinal products including the placebo.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- medical and health sciences clinical medicine endocrinology diabetes
- medical and health sciences health sciences infectious diseases viral diseases RNA viruses HIV
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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Topic(s)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-GH-EDCTP3-2023-01
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08036 Barcelona
Spain
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.