Periodic Reporting for period 1 - ARISE (African Research and Innovative Initiative for Sickle cell Education: Improving Research Capacity for Service Improvement)
Berichtszeitraum: 2019-01-01 bis 2022-10-31
Sickle Cell Disease (SCD), the world’s most common monogenic disease, is one of the most neglected non-communicable diseases. SCD prevalence approximates 400,000 annul births per year and about 100 million patients worldwide. Over 75% of its global burden occurring in Sub-Saharan Africa (SSA) and affecting about 1-3% of all births in this region. SCD is a systemic disease and is associated with multiple complications covering a very broad spectrum and requiring complex self-care and clinical management. SCD-related comorbidities and symptoms include anaemia, bacterial infections and chronic organ damages and dysfunction, such as stroke, renal failure and cardiac damage. These debilitating complications are associated with premature death and contribute to about 16% of all under five deaths in SSA. Interventions introduced during the last decades, including newborn screening (NBS), penicillin prophylaxis and hydroxyurea, have reduced mortality and morbidities in early childhood. Additionally, preventive and comprehensive care, self-management, effective acute care management and well-trained healthcare providers can reduce the disease’s chronic complications. Nevertheless, such programmes have not been implemented widely and remain rare in SSA. Life expectancy for SCD patients in SSA is stagnating to less than 20 years on average (3x less than the general population). ARISE aims to implement a large staff exchange programme across EU and non-EU institutions providing training and improving clinical and research skills. Using Implementation Science, ARISE fosters sharing of best practices in NBS, diagnosis and treatment of SCD leading to improvement in overall disease outcome
All the 8 Work Packages (WPs) are progressing well towards their objectives and already obtained several achievements.
WP1 (Coordination and Management): Development of tools and templates to organise and run secondments; daily support to partners and secondees; monitoring and evaluation of ARISE actions; The spread of the COVID pandemic requested to amend the GA for project suspension and restart, and for extension. Contingency measures for secondments to reduce the impact of the pandemic; Changes in the partnership: inclusion of 4 new institutions from Italy, Portugal, Zambia and Angola to replace 2 partners from Italy and Greece
WP2 (eHealth technologies): Analysis of ethical and legal requirements for processing personal and health data and for handling human samples in Nigeria, Kenya, Angola, Zambia and Lebanon, Run of 2 pilot studies “to map and assess selected clinical centres managing SCD patients” and “to assess the needs of SCD patients and healthcare workers involved in SCD management” and result dissemination. Extension of the pilot and new studies ongoing; Publication and update of the project website (with WP7), it includes an e-library to share knowledge and disseminate SOPs, leaflets and info graphics that can easily be accessed and re-used.
WP3 (laboratory diagnostics and quality assurance systems): A combined gap analysis and baseline needs assessment conducted in Nigerian laboratories; Virtual lectures delivered through the Virtual Teaching Programme developed to mitigate secondments’ suspension due to the pandemic; UK NEQAS external quality assurance for NBS programme launched in Kaduna and Kafanchan states in collaboration with ASH Consortium on Newborn Screening in Africa (CONSA).
WP4 (Newborn SCD screening and clinical management): Testing the feasibility of a sustainable NBS programme for SCD in LMICs and building laboratory capacity and improving diagnostic accuracy through training and mentoring; Developing protocols to manage complications and routine health maintenance therapies; Deploying Implementation Science strategies to promote the uptake of these interventions also through staff exchanges on community, policymaker and healthcare provider engagement.
WP5 (training in molecular diagnostic techniques and Genetic Counselling and research): 3 studies established reflecting the training and research capacities of partners to facilitate the process of designing, planning and carrying out secondments: i. Molecular Diagnostics for Haemoglobinopathies; ii. Genotype-phenotype correlations and genetic modifiers of haemoglobinopathies; iii. Epidemiological surveys and data collection on haemoglobinopathies.
WP6 (training and support for clinical research): Building capacity for research, analysing and publishing already existing data, providing training and support for clinical research and strengthening collaborative links within the partnership.
WP7 (Dissemination and Communication): Strategy designed and implemented; ARISE graphical identity developed; leaflets, banner and badges designed and produced; project specific profiles created on social media (Twitter, Instagram, Linkedin); News and blogs published; ARISE Radio jingles; Advocacy letters and visits in Nigeria; COVID-19 related activities (website content, webinar, newsletter and videos); ARISE programme and achievements promoted at various events such as the Annual Scientific Conference on Sickle Cell and Thalassaemia (ASCAT) since 2020 and the 4th Global Congress on SCD (Paris, 2022).
WP8 (Ethics): To ensure compliance of activities with the applicable EU, international, and national regulatory requirements and ethics provisions, strong collaboration created with the ARISE PMT, secondees and hosting and sending institutions; Ethics Advisor appointed and continuously consulted on planned and ongoing research activities, studies design and submissions to the Ethics Committees. Data Protection Impact Assessment conducted for all data processing activities and for the evaluation of ethics risks; Templates prepared and made available for adaptation and use in research activities (Informed consent form, age-appropriate assent form, Data Sharing & Material Transfer Agreement).
Finally all WP collaborated in two train-the-trainer workshops held in Sept. 2019 and Aug. 2022 in Nigeria (over 150 delegates and 10 various institutions each) to enhance the knowledge of professionals involved in SCD management, with focus on SCD management and laboratory skills.
WP1 (Coordination and Management): Development of tools and templates to organise and run secondments; daily support to partners and secondees; monitoring and evaluation of ARISE actions; The spread of the COVID pandemic requested to amend the GA for project suspension and restart, and for extension. Contingency measures for secondments to reduce the impact of the pandemic; Changes in the partnership: inclusion of 4 new institutions from Italy, Portugal, Zambia and Angola to replace 2 partners from Italy and Greece
WP2 (eHealth technologies): Analysis of ethical and legal requirements for processing personal and health data and for handling human samples in Nigeria, Kenya, Angola, Zambia and Lebanon, Run of 2 pilot studies “to map and assess selected clinical centres managing SCD patients” and “to assess the needs of SCD patients and healthcare workers involved in SCD management” and result dissemination. Extension of the pilot and new studies ongoing; Publication and update of the project website (with WP7), it includes an e-library to share knowledge and disseminate SOPs, leaflets and info graphics that can easily be accessed and re-used.
WP3 (laboratory diagnostics and quality assurance systems): A combined gap analysis and baseline needs assessment conducted in Nigerian laboratories; Virtual lectures delivered through the Virtual Teaching Programme developed to mitigate secondments’ suspension due to the pandemic; UK NEQAS external quality assurance for NBS programme launched in Kaduna and Kafanchan states in collaboration with ASH Consortium on Newborn Screening in Africa (CONSA).
WP4 (Newborn SCD screening and clinical management): Testing the feasibility of a sustainable NBS programme for SCD in LMICs and building laboratory capacity and improving diagnostic accuracy through training and mentoring; Developing protocols to manage complications and routine health maintenance therapies; Deploying Implementation Science strategies to promote the uptake of these interventions also through staff exchanges on community, policymaker and healthcare provider engagement.
WP5 (training in molecular diagnostic techniques and Genetic Counselling and research): 3 studies established reflecting the training and research capacities of partners to facilitate the process of designing, planning and carrying out secondments: i. Molecular Diagnostics for Haemoglobinopathies; ii. Genotype-phenotype correlations and genetic modifiers of haemoglobinopathies; iii. Epidemiological surveys and data collection on haemoglobinopathies.
WP6 (training and support for clinical research): Building capacity for research, analysing and publishing already existing data, providing training and support for clinical research and strengthening collaborative links within the partnership.
WP7 (Dissemination and Communication): Strategy designed and implemented; ARISE graphical identity developed; leaflets, banner and badges designed and produced; project specific profiles created on social media (Twitter, Instagram, Linkedin); News and blogs published; ARISE Radio jingles; Advocacy letters and visits in Nigeria; COVID-19 related activities (website content, webinar, newsletter and videos); ARISE programme and achievements promoted at various events such as the Annual Scientific Conference on Sickle Cell and Thalassaemia (ASCAT) since 2020 and the 4th Global Congress on SCD (Paris, 2022).
WP8 (Ethics): To ensure compliance of activities with the applicable EU, international, and national regulatory requirements and ethics provisions, strong collaboration created with the ARISE PMT, secondees and hosting and sending institutions; Ethics Advisor appointed and continuously consulted on planned and ongoing research activities, studies design and submissions to the Ethics Committees. Data Protection Impact Assessment conducted for all data processing activities and for the evaluation of ethics risks; Templates prepared and made available for adaptation and use in research activities (Informed consent form, age-appropriate assent form, Data Sharing & Material Transfer Agreement).
Finally all WP collaborated in two train-the-trainer workshops held in Sept. 2019 and Aug. 2022 in Nigeria (over 150 delegates and 10 various institutions each) to enhance the knowledge of professionals involved in SCD management, with focus on SCD management and laboratory skills.
The promotion of cooperation between African, US, and European researchers can effectively ease the deployment of interventions – NBS, comprehensive care and self-management programmes for SCD – to reduce mortality and morbidities in early childhood and improve the overall disease outcome. Moreover: 1. Secondees engagement is producing results at individual level (improved skills, research planning and conduction, clinical expertise, presenting and discussing research findings, career improvements), and at institutional level (development and implementation of protocols for clinical management, inclusion in wider research consortia); 2. The project is developing a sustainable, context-based and comprehensive plan for SCD, which takes into account also sociocultural factors. Implementation science will facilitate its deployment and allow the rapid assessment of its impact; 3. ARISE is implementing a Community Stakeholder Engagement strategy with internal & external stakeholders to raise awareness of the project, its activities and outcomes.