The MA-CoV project will include three work packages (WPs) as major sub-divisions of the work: WP1 devoted to the project management, WP2 that allocates work and activities regarding the clinical study and related training activities, and a third WP that comprises the communication, networking and advocacy activities as well as dissemination of findings.
WP 1: Project Management
WP1 will be coordinated by Dr Mireia Piqueras (ISGlobal, Spain) and will deal with strategic direction, optimizing the use made of the project committees, and supervising WP leaders as they execute their role. It will entail overall steering of the project, thereby linking with all Executive Committee activities. It will centralize all efforts addressed to maximize scientific quality of the project’s outputs, including quality assurance mechanisms, and guarantee continuous supervision of ethical issues on all the project’s fronts, including timely detection, analysis and documentation, therefore creating an ethical awareness layer that will impregnate all of the project activities. An important chapter under this WP is the risk management (through careful identification of possible risks and implement appropriate contingency measures) to fight the uncertainty produced by the COVID-19 pandemic. As MA-CoV is presented as an ancillary study to the EDCTP funded project MAMAH (RIA2016MC-1613), the management of MA-CoV will follow the paths already stablished in MAMAH in a coordinated effort.
The Scientific Coordination led by Dr Raquel González, as overall project coordinator, will be fully aligned with all Project Management activities throughout the project, in order to ensure highly efficient and synergistic leadership efforts. All the African and European institutions involved in the project will be represented in the management of the consortium (Executive Committee) in order to ensure the coordination between partners and strengthen networking. The development of a management and coordination strategy is essential for efficient and effective implementation and monitoring of the project. In this sense, the tasks involved in this work package directly facilitate the accomplishment of the other work package objectives and the overall project goal, and include:
- Development of a project management strategy to help ensure implementation and integration of work packages activities and minimize risks and conflicts that could arise during the project.
- Developing and monitoring a project timeline to meet established milestones and objectives.
- Developing a system for financial and contractual monitoring to ensure project funds are appropriate disbursed and used.
WP 2: Clinical Study and Training
The core of the Project clinical activities falls under WP2, coordinated by Dr Tacilta Nhamposa (FM-CISM, Mozambique) and co-led by Dr Ghyslain Mombo-Ngoma (CERMEL, Gabon), both principal investigators for MA-CoV in Mozambique and Gabon, respectively. This WP will aims to address urgent research questions in the context of the current COVID-19 outbreak and maternal and neonatal health, which are in line with the research priorities of the Global Research Roadmap and the WHO R&D Blueprint for rapid activation of R&D activities during epidemics, mainly falling under Objective 1 (Clinical characterization of disease in different populations and risk groups, across the spectrum of severity through detailed observational studies), which may in the nearest future optimise the standard care of pregnant women (Objective 3). The WP2 leader will overview the entire development of the study, in close collaboration with the co-leader, the WP1 leader and the Project Coordinator. The activities included in WP2 will be critical for the successful accomplishment of the project’s objectives. This WP2 will also take the responsibility for the training activities necessary to execute the study at a level of excellence and strengthening of national and local research capacity. A Data Management Plan is currently being prepared in order to ensure that quality-controlled data is shared in accordance with the FAIR (findable, accessible, interoperable and re-usable) principles.
The tasks involved in this WP include:
- Preparation of the study protocol and tools
- Definition of a Study Progress Plan
- Implementing an incidental findings policy
- Creation of the Training Plan including activities that may reinforce the local research capacity
- Preparation of a Statistical Analysis Plan
WP3: Communication, Networking, Dissemination, and Advocacy
This WP will be led by Dr Meral Esen (EKUT) and co-led by Dr Michael Ramharter (BNITM). This WP will contribute to achieving the project objectives through collaboration between the European and African partners involved, but also with those stakeholders participating in other studies in COVID-19 and Maternal and Infant Health, by facilitation of interactions, in order to optimise funding efforts. This WP aims at translating the findings of this study into health policies by contributing to WHO Global COVID-19 Clinical Data Platform. For this purpose, and since sharing of knowledge will increase the strength and impact of the project, activities to improve the communication flow among partners, strengthen links and establish new networks between researchers and policy makers, and raise awareness on the topic will be put in place. The team will explore possible synergies and concrete ways to coordinate efforts and collaborate with any other EDCTP-funded studies of the same or related topic. In the same vein, this WP will also foster collaborations with public and private partners such as policy makers (Ministries of Health NMCPs, WHO), other health authorities, NGOs, pharmaceutical companies involved in drug development to ensure that the impact of all research is maximised by identifying synergies, leveraging resources and investments and trying to avoid unnecessary overlapping. This WP will support WP2, in synergy with WP1, in order to guarantee effective communication within the Consortium.