The SkincAIr project aims to develop an innovative AI-driven mobile application to support the early detection and of skin Neglected Tropical Diseases (skin NTDs) in Sub-Saharan Africa (SSA). NTDs significantly affect marginalized communities due to several factors, such as lack of trained healthcare staff and diagnostic tools. The project's objectives are: to improve the accuracy of Front-line Health Workers (FHW) of skin NTD identification, to create the largest public dataset of skin NTDs in the world (first in SSA), to reduce disease transmission through early diagnosis, to enhance real-time epidemiological surveillance, to enhance the knowledge of FHW, to develop novel AI models for skin disease monitoring, to ensure the digital solution is culturally tailored, to ensure compliance with clinical practices, ethical, legal aspects and participant rights, to ensure scalability and broad outreach of SkincAIr’s results, to advocate for greater awareness and policy support for NTDs SkincAIr will equip FHW with an app capable of detecting skin NTDs using advanced machine learning techniques while preserving privacy through geolocation features. The app will facilitate real-time epidemiological surveillance, contributing to improved disease mapping and hotspot identification. The project will be implemented in five SSA countries: Kenya, Senegal, Ethiopia, Nigeria, and the Democratic Republic of the Congo. Aligned with the Work Program, SkincAIr is anchored in the scope of Global Health EDCTP3 and regional strategies, targeting the highest demonstrated medical needs in SSA and addressing context-specific needs. It develops a solution with early-stage involvement of end users and implicated health services. The solution ensures seamless integration and interoperability, is sustainable, accessible, open-source, evidence-based, and compliant with data protection standards and global digital health public goods.

Leprosy (Hansen disease) and Buruli ulcer are among the devastating skin neglected tropical diseases (Skin NTDs) prevalent in sub-Saharan Africa that cause progressive and permanent disabilities, exposing the patients and their families to discrimination, social stigma, and economic burden, adding complex challenges to communities already exposed to extreme inequality. Considering the needs of the most affected populations, children and people living in rural remote areas, current treatments are suboptimal in their complexity and length. Treating leprosy requires multiple drugs administered for 6 to 12 months. Buruli ulcer treatment requires 3 pills daily at different hours for two months, and lesion healing can take up to 12 months. Both treatments are associated with significant side effects (skin discoloration from clofazimine, exacerbating the stigma that leprosy patients face, and potentially fatal hypersensitivity to dapsone). This proposal aims to transform the treatment of Buruli ulcer and leprosy using the novel compound telacebec. Telacebec has demonstrated profound activity against Mycobacterium ulcerans and Mycobacterium leprae, the causative agents of Buruli ulcer and leprosy, respectively, whose evolutionary biology has rendered them hypersusceptible to killing by telacebec. We propose to conduct two clinical trials with telacebec-based treatment regimens that will cure Buruli ulcer and leprosy with fewer drugs, shorter duration, and fewer side effects than current therapy. We will perform this work through an integrated, multidisciplinary consortium of experts with broad experience in drug development, therapeutic delivery, community engagement, stakeholder participation, policy implementation, and capacity building to achieve equitable access to a new standard of care for these diseases.

Why RER-CTO?: The conduct of clinical trials requires competent ethics committee and regulatory authorities that can review clinical trial applications and monitor processes independently and efficiently ensuring the safety of clinical trial participants, and the integrity and reliability of the generated data. The capacity of most African regulatory authorities regarding clinical trial review and oversight is weak due to poor infrastructure, limited resources both human and financial, lack of expertise, un-conducive working framework and lack of systems adequately supported by technology. Collaboration between academia, international organizations, National ethics committees (NECs) and national regulatory authorities (NRAs) are mandatory to produce sustainable regulatory skills and functional clinical trial oversight systems. The RER-CTO consortium consists of a group of well reputable clinical trial researchers, regulatory authorities, ethics committees, universities and research institutes in Ethiopia, Tanzania, Norway, and Sweden. Our aim is to achieve ethics and regulatory excellence and harmonization in sub-Saharan Africa in clinical trial oversight (CTO) by improving the legal and policy framework by identifying gaps and making recommendations, improving regulatory and research ethics oversight capacity and capability by digitalising the clinical trial oversight systems and developing training programs to strengthen competency of relevant stakeholders, and strengthening local, regional, and international collaborations and coordination of NECs and NRAs for clinical trial oversight by developing joint clinical trial review guidelines. These efforts are geared towards increasing clinical trials in sub-Saharan Africa, standardization of clinical trial review and monitoring processes, and promoting ownership, efficiency, linkages for data sharing, transparency, and accountability of clinical trial review processes.

P. vivax is considered the most difficult human malaria to eliminate because of the inability of conventional diagnostics to detect individuals with latent liver forms. These individuals account for 80% of all infections and can readily infect mosquitoes. Currently countries can test knowing this has little impact or and the treat everyone which exposes individuals to drugs with potentially dangerous side effects. Parasite specific antibody responses have been shown to correlate with the likelihood of hypnozoite carriage and can be used to identify individuals who should be treated. Aim is to implement a Cluster-Randomised Trial in Ethiopia and Madagascar to demonstrate the effectiveness of a new anti-malaria intervention based on Plasmodium vivax serological testing and treatment (PvSTATEM) with primaquine to prevent the relapse infections responsible for maintaining P. vivax transmission. Simultaneously, we will assess social and health system acceptability of such an approach as well as refine new mobile technologies which interface with point-of-care diagnostic tests and guide treatment decisions. We aim to reduce malaria burden at both the individual and population level in two countries which experience the highest levels of P.vivax in Africa. We expect to have a significant effect in reducing morbidity and improving health. We will ensure community engagement and assess the adoption of new technologies that align with those existing in the health system. The proposal is built on equal partnership and shared capacity to address a substantial public health burden.

The 21st century witnesses increased incidence of epidemics (Zika, dengue, Ebola, SARS), with as latest highlight the recent COVID-19. Following the outbreak of several infectious diseases during the last few decade, the need for generating real-time pathogen genomic data for public health action has become more important than ever. In the African context, infrastructure, human resource capability, data analysis, including bioinformatics, lack of linkage between clinical, epidemiological, and pathogen genomic data as well the interaction between clinicians, researchers and decision makers are some of the major challenges. The aim of the EpiGen project is to build a capacity for integrated pathogen genomic surveillance for informed public health decision process. The overarching specific objectives include strengthening collection and analysis of clinical and epidemiological data, enhancing the capacity and capability for pathogen genomic sequencing, including strengthening the laboratory infrastructure, human work force, pathogen genomic data analysis, and the integration of metadata with genomic data, developing and implementing innovative digital diagnostic platforms, creating semi-real time mobile phone applications for policy decisions, and promoting communities of practice and knowledge exchange through fostering African collaboration and networking in the domain of pathogen genomic surveillance for infectious diseases. EpiGen project’s multi-disciplinary consortium is drawn from several institutions from Ethiopia engaged in National Public Health Programs, and EU partners (The Netherlands, Spain and Germany). Overall, the model approach proposed by EpiGen will enhance Ethiopia’s national effort in mitigating the threat of infectious diseases. The implementation of a national genomic-informed surveillance for infectious diseases will play significant public health role towards contributing to disease prevention and control programmes in Ethiopia and beyond.