The Integrate study : An adaptive platform trial for the development of a new intervention to combat Lassa fever in Africa

Informations projet

INTEGRATE

N° de convention de subvention: 101103204

DOI

10.3030/101103204

Date de signature de la CE 23 Juin 2023

Date de début 1 Juillet 2023

Date de fin 30 Juin 2028

Financé au titre de

• Health

Coût total

€ 8 800 000,00

Contribution de l’UE

€ 8 000 000,00

Coordonné par

UNIVERSITE DE BORDEAUX
France

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Livrables

Websites, patent fillings, videos etc. (2)

Dissemination and Exploitation Plan

A Plan for Dissemination and Exploitation including Communities will describe how the projects and its results will be shared with various stakeholders, including the communities.

INTEGRATE webpage

A webpage will be established to inform on the project and its results

Documents, reports (5)

Statistical analysis plan

The plan will describe all statistical analyses that will be conducted by UB.

Manual for clinical management of LF patients

This manual, describing standardized use of diagnosis and clinical management for trial participants with Lassa fever (including common medical complications), will be implemented at each site prior to the start of trial activities, to ensure that trial participants receive adequate medical care.

Phase II-III protocol

This is the trial full protocol.

Project management handbook

The handbook will describe all the project decision-making process, reporting templates and progress sheets necessary for the collaboration between all the partners.

Community sensitization plan

Following the first cross-sectional survey among community members a community sensitization plan will be designed to guide the implementation of community sensitization actions before and during the trial.

Data Management Plan (1)

Data management plan

It will describe how the data will be managed and shared in respect of the FAIR principles and the General Data Protection Regulation as well as national laws.