Clinical Research Directory

Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers

Skin-related Neglected Tropical Diseases (Skin NTDs) affect about 1.8 billion people worldwide, particularly in poor and rural communities where healthcare access is limited. Many people rely on frontline health workers (FHWs) for treatment, but these workers often lack specialized training in skin diseases, making diagnosis difficult. To address this challenge, the SkincAIr project is testing whether a mobile app powered by artificial intelligence (AI) can help FHWs improve their ability to detect Skin NTDs. The study will be conducted in two arms. In the first clinical image data collection arm (36 months), dermatologists in 5 countries (Kenya, Ethiopia, Senegal, Democratic Republic of Congo and Nigeria) will collect images of skin NTD and other skin conditions that will be used for development and training of the AI model within the SkincAIr app before it is tested among FHWs. The second validation study arm will take place in 3 countries (Kenya, Ethiopia and Senegal), and will involve 50 FHWs and around 750 patients in each country over 24 months. During the first 12 months (Phase A), FHWs will diagnose patients using standard methods without the app, establishing baseline performance on key indicators including diagnostic accuracy, time to diagnosis, referral patterns, and cost implications of improved primary-level diagnosis. For the following 6 months (Phase B), FHWs will use the SkincAIr app with AI functionality activated to support diagnosis and enable real-time geolocated disease mapping and hotspot identification. In the final 6 months (Phase C), the app is withdrawn to assess whether FHWs retain their improved diagnostic skills. We will summarize the results using simple numbers and charts to show how often things happen and what the average results look like. Researchers will evaluate how well the app improves diagnosis by FHWs and whether FHWs retain their improved skills even after AI support is removed, by comparing their results with those of a skin specialist (dermatologist). Interviews and group discussions will be recorded, written down, organized into key ideas, and carefully reviewed using a computer program to understand the main themes. Study findings will be shared with National Ministries of Health, presented at local and international conferences, and reported to relevant institutional and regulatory authorities. If successful, this AI tool could boost early detection of skin diseases, enhance disease tracking, and improve healthcare in underserved areas.

Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to metformin 1000mg OD versus placebo for 24 weeks in addition to MDT during 48 weeks. The main research question is whether adjunctive metformin, combined with MDT, will improve the clinical outcomes of patients with multibacillary leprosy by mitigating leprosy reactions, thereby reducing nerve damage and corticosteroid use and its associated morbidity. The second aim is to explore whether adjunct metformin, added to MDT, has an acceptable tolerability and safety in patients with multibacillary leprosy.

Implementation of the COmmunity HEalth System InnovatiON Project in Low- and Middle- Income Countries

The COHESION-I project will evaluate the effects of the co-creation intervention (2016 to 2019) and the co-design intervention (2023 to 2024) on improving (a) health system responsiveness, and (b) patient satisfaction, at the primary health care level, in Peru, Nepal and Mozambique, in relation to chronic diseases (hypertension, and diabetes mellitus), as well as specific neglected tropical diseases. Each intervention has been tailored to the context and characteristics of each one of the aforementioned low- and middle-income countries. For this quasi-experimental study, three arms were established: the co-creation (2016 to 2019) + co-design (2023 to 2024) arm; the co-design only (2023 to 2024) arm; and the control group (no intervention; usual care). The evaluation will be composed of four types of evaluations: quantitative; qualitative; economic; and process evaluation