SEMA ReACT

Severe malaria in remote areas: Closing the evidence gap

Background

Annually, almost 500,000 children under 5 years die from malaria in Africa. Timely access to effective antimalarial therapies is lifesaving as treatment with pre-referral rectal artesunate capsules (RAS), followed by injectable artesunate (InjAS) and 3-day treatment with artemisinin-based Combination therapies (ACTs) leads to an observed 96% reduction in mortality. Although recommended by the WHO for years, RAS deployment has been very limited. The full treatment paradigm is not always feasible when access to primary healthcare facilities is limited due to lack of transport, non-availability of services, and cost. Rollout has recently been paused, as outcomes data is incomplete in these contexts making the development of best practice recommendations challenging. Hence the relevance of the proposed study.
 

SEMA ReACT

The proposed project is an observational, non- inferiority study in Zambia and the Democratic Republic of Congo (DRC). Community Health Care Workers will identify/diagnose, treat and follow up patients with (severe) malaria as part of integrated community case management. The consortium will assess and mitigate operational and institutional facilitators and barriers at the level of all stakeholders (patients, caregivers, health care providers, regulators, malaria experts) and recommend sustainable policies for this remote context. This generated evidence will support policy development and implementation. The proposed Consortium brings together vital experience in the rollout and deployment of RAS, study design and execution, social science research, data collection & management, stakeholder engagement, and translation of research results into clinical practice.

 

Timeline and funders

The 4-year (April 2023 – March 2026) SEMA ReACT project is funded by the European and Developing Countries Clinical Trials Partnership (Global Health EDCTP3), co-funded by the European Union and the Swiss State Secretariat for Education, Research and Innovation (SERI).

Work packages

Work Package 1: Management and coordination

Led by jean-pierre [dot] vangeertruyden [at] uantwerpen [dot] be (Professor Jean-Pierre Van geertruyden), Global Health Institute, University of Antwerp (UA), Belgium.

WP1 will ensure the overall coordination and administration of the study and execute the decisions made by the CSC. Among its many responsibilities, WP1 will oversee and support the progress of other WPs, ensuring timely compliance with the grant agreement including financial and technical reporting.
 

Work Package 2: Study operations

Led by cmanyando [at] yahoo [dot] com (Dr Christine Manyando), Tropical Diseases Research Centre (TDRC), Ndola, Zambia

WP2 is responsible for operational execution, including study site assessments and enrolment, site-readiness activities, capacity building to support high-quality data capture, and patient monitoring. It brings together research institutes from Zambia, DRC and Tanzania and will be coordinated by local malaria experts well versed in the challenges of malaria case management in rural districts. Dr Manyando also serves as the scientific lead of the Consortium.
 

Work Package 3: Social science research

Led by aimekakudji [dot] kyungu [at] gmail [dot] com (Prof Aimé Kakudji Kyungu), University of Kinshasa (UNIKIN), DRC

WP3 will provide expertise in social science research and trial ethics and support all social science aspects of the study design and delivery. WP3 results will enable an understanding of community responses to RAS administration, especially factors that facilitate or hinder adherence to the strategy. These will be vital for future implementation in other similar settings. WP3 also seeks to understand the major political and sociological barriers for wider implementation of RAS in high burden areas.
 

Work Package 4: Data management and analysis

Led by Tafadzwa [dot] Maseko [at] uantwerpen [dot] be (Tafadzwa Maseko), University of Antwerp (UA)

WP4 will oversee data management and analysis of clinical data within the standards recognised by stringent regulatory authorities. It will be responsible for handling all sensitive patient data and overall data quality; and will help identify and support delivery of any training required to upskill clinical site staff and local doctoral students. This support will extend to training in data analysis and population statistics for principal investigators (PIs) and authors of any resulting publications.
 

Work Package 5: Communication, dissemination and exploitation

Led by rietveldh [at] mmv [dot] org (Hans Rietveld), Medicines for Malaria Venture (MMV)

WP5 will work with the partners and national malaria control programmes of Zambia, DRC and Tanzania to ensure regular and timely communication of information about the study and its findings to key stakeholders. It aims to exploit the research results to their full potential, and support uptake, so that people at risk of severe malaria in sub-Saharan Africa have access to safe health technologies of proven efficacy.

Members of the Consortium

Global Health Institute, University of Antwerp (Belgium)
The Malaria Research group (MaRch) of the Globlal Health Institute at the University of Antwerp (UA), leads research designed to overcome challenges in malaria treatment, working in partnership with universities in endemic countries.

The Tropical Diseases Research Centre (TDRC), Zambia
The Tropical Diseases Research Centre (TDRC) was initiated by the WHO in collaboration with the Zambian Government in 1975 to intensify the level of research into tropical diseases being done in low-to-middle income countries where diseases remain endemic. The TDRC has strong links with the UA and the NMEC in Zambia.

The University of Kinshasa (UNIKIN), Democratic Republic of Congo
The University of Kinshasa (UNIKIN) is the largest state university in the DRC. Through its Department of Tropical Medicine, it is involved in several projects on malaria and Ebola vaccine development. UNIKIN provides expertise to the Ministry of Health and helps guide policy decisions and has a long-lasting and fruitful collaboration with the UA.

Medicines for Malaria Venture (Switzerland)
Medicines for Malaria Venture (MMV) is a Product Development Partnership in the field of antimalarial drug research and development. MMV has helped create the world’s largest antimalarial drug development portfolio and supports activities to ensure access to medicines for the most vulnerable.

National Institute for Medical Research (Tanzania)
The National Institute for Medical Research (NIMR) is a government parastatal institution in Tanzania. NIMR focuses on research in HIV TB, NCDs, clinical trials, and disease surveillance. NIMR has delivered successfully on several complex trials and implementation studies that have influenced global guidelines.

SEMA ReACT Scientific Lead

Photo: Christine Manyando
Dr. Christine Manyando

Dr. Christine Manyando is a physician and clinical research scientist working for Tropical Diseases Research Centre (TDRC), Ndola, Zambia as team leader for Malaria Research and head of Public Health Department. Her research experience spans over 2 decades focusing on epidemiological and clinical research in Malaria, TB and HIV. She served as WHO adviser for over 15 years supporting quality management of clinical trials in Africa and Asia with a focus on training in Good Clinical Practices (GCP) and monitoring of WHO funded clinical trials in Malaria, Tuberculosis and HIV.

Her research over the years has culminated in development of new anti-malarial drugs, new ways of using old antimalarials; including their use in malaria in Pregnancy. She has served on several scientific advisory committees; Data Safety Monitoring Boards (DSMBs) for several Clinical Trials, including the COVID 19 Vaccine development safety monitoring Board, European and Developing Countries Clinical Trials Partnerships (EDCTP), Quality Management Advisory Committee (QMAC) of WHO-TDR, Medicines for Malaria Venture Scientific Advisory Committee (MMV-ESAC) among others. As well as on the ethics and adjudication boards to anchor health research on the continent of Africa and beyond.

Dr. Manyando has also served on humanitarian and other non-medical Boards for over a decade, such as the Seeds of Hope International Partnerships Board, Mailis and Tina Foundation of Hope International (which she still serves on as co-founder), United Bank for Africa (UBA), Zambia Board among others.

SEMA ReACT Coordinator

Photo: Jean-Pierre Van geertruyden
Prof Van geertruyden

Prof Van geertruyden started his career with 15 years of operational experience in humanitarian aid and development cooperation in themes as outbreak investigation, emergency preparedness, disease control for on cholera, measles, HIV, STIs, meningitis, malnutrition,... and health system strengthening. He joined the academic world via a PhD on malaria-HIV interactions and continued to work on malaria since two decades. He founded and coordinates both MaRch and the Global Health Institute and is founding member of the MIMalaria Society, a global non-profit organization whose mission is to unite all human resources, young and experienced, working on malaria (from researchers over implementers, teachers, producers, funders, policy makers) to strengthen and sustain the capacity of malaria affected countries and to be an umbrella organization for all malaria related initiatives.

His main expertise lies in bio-statistical support, designing and implementing (clinical) epidemiological study designs and conducting clinical trials (Phase 1-2-3), diagnostic test research and vaccine trials. (Development of) molecular tools and social sciences (mixed methods) are incorporated in most of his studies. Last years, his interest is evolving towards implementation research. He has active ongoing collaborations going with DRCongo, Tanzania, Zambia, Cameroon, Burundi, Uganda, Peru, Ethiopia, The Gambia, Kenya,... and several institutions in High Income Countries.

National Malaria Control Programme Partners

National Malaria Control Programme of the Democratic Republic of Congo
The Programme National de Lutte contre le Paludisme (PNLP) in DRC is under the General Secretariat of the Ministry of Health. The NMCP is the policy maker and responsible for all activities related to malaria management in the country. It engages stakeholders to make sure that the policies are evidence-based and to guarantee a good dissemination.

National Malaria Elimination Centre of Zambia
The National Malaria Elimination Centre (NMEC) in Zambia is under the Ministry of Health (MoH). The NMEC regularly engages multi-level stakeholders to implement the strategic plan and update malaria programming guidelines and protocols.

National Malaria Control Programme of Tanzania
The National Malaria Control Programme (NMCP) in Tanzania is under the Ministry of Health (MoH). The NMCP regularly engages multi-level stakeholders to implement the strategic plan and update malaria programming guidelines and protocols.