PREVENTING AND DELAYING THE DEVELOPMENT OF DIABETES IN AFRICA: A RANDOMISED PLACEBO -CONTROLLED DOUBLE-BLIND PHASE III TRIAL OF METFORMIN IN HIV-INFECTED PERSONS WITH PRE-DIABETES

Projektinformationen

The META Trial

ID Finanzhilfevereinbarung: 101145764

DOI

10.3030/101145764

EK-Unterschriftsdatum 5 März 2024

Startdatum 1 Januar 2025

Enddatum 31 Dezember 2026

Finanziert unter

• Health

Gesamtkosten

€ 1 811 067,50

EU-Beitrag

€ 1 811 067,50

Koordiniert durch

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA
Spain

CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.

Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.

Leistungen

Documents, reports (6)

Draft stewardship plan

The stewardship plan outlines how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies

Study initiation package

The study initiation package will include the following information from the beginning of the trial:• Registration number of the clinical study in a registry meeting WHO Registry criteria• Final version of study protocol as approved by the regulator(s) / ethics committee(s)• Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient)Th study intiation package will also include: • The submission of the updated protocol with new progress plan and dates • The ethics extension and approval letters from relevant national bodies

Midterm Recruitment Report

This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Exploitation and dissemination plan

English Word file on a revised and updated exploitation and dissemination plan will be submitted.

Collection of documents related to the status of the clinical trial

PDF consisting of the collection of documents related to the status of the clinical trial

Updated Project Plan

A final English Word document outlining the updated project’s implementation phase and timeline.

Websites, patent fillings, videos etc. (1)

Project Website

Relaunch of project website

Data Management Plan (1)

Updated data management plan

Update of the Data Management Plan (DMP)

Veröffentlichungen

Peer reviewed articles (1)

Process Evaluation of a Metformin RCT for People Living with HIV with Pre-Diabetes in Tanzania (META Trial): a study protocol

Autoren: Nandakumar Ravichandran, John Broughan, Geoff McCombe, Sheila Loughman, Sokoine Kivuyo, Faith Aikaeli, Doreen Pamba, Erik Van Widenfelt, Magreth Mbena, Jeffrey V Lazarus, Sayoki Mfinanga, Kaushik Ramaiya, Shabbar Jaffar, Anupam Garrib, Walter Cullen
Veröffentlicht in: HRB Open Research, Ausgabe 8, 2025, ISSN 2515-4826
Herausgeber: F1000 Research Ltd
DOI: 10.12688/HRBOPENRES.14251.1