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 In the final 6 months (Phase C), the app is withdrawn to assess whether FHWs retain their improved diagnostic skills.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.

Host Response to Infection and Treatment in Filarial Diseases

This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment. Filarial infections are caused by parasitic worms. The immature worm (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2 to 4 inches in length. Although many of these infections do not produce symptoms, especially in the early stages of infection, others can have serious consequences, including swelling of the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to blindness, and heart disease. This protocol does not involve any experimental diagnostic procedures or treatments, and will use only procedures employed in the standard practice of medicine. Persons between 3 and 100 years of age diagnosed with or suspected of infection with Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms may be eligible for this study. Participants will have routine tests to determine the specific type of filarial infection. These may include special tests of the lungs, skin or heart, depending on the type of parasite suspected. Patients with skin reactions may have a "punch biopsy" to examine a small piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage. For this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give medications. A pencil-thin tube is then passed through the nose or mouth into the lung airways to examine the airways. Salt water is injected through the bronchoscope into the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done only if medically necessary and only on patients 21 years or older.) Once the diagnosis is established, standard treatment will be instituted with either diethylcarbamazine or ivermectin, depending on the type of infection. Additional procedures for research purposes include: * Extra blood draws to study immune cells and other immune substances. (This is the only research procedure that will be done in - More frequent and extensive follow-up evaluations than usual for routine care. They will include physical examination and blood studies. * Urine collections at specified periods, possibly including 24-hour collections. * Skin tests to examine the body s reaction to allergens-common environmental substances, such as cat dander or pollen-that cause an allergic reaction. The test is done in one of two ways: either the skin is lightly scratched and an allergen extract is placed over the just-broken skin, or a very fine needle is used to inject a small amount of allergen under the skin. In both methods, the site is monitored for swelling or hives in the next 48 hours. * Leukapheresis (only on patients 21 or older ) to collect quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.

Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis

The primary purpose of this phase 3b study is to determine the safety and efficacy of moxidectin administration twice a year, compared to once a year, in maintaining undetectable levels in skin of O. volvulus microfilaria in skin, the parasite that causes river blindness. Secondary purposes are to determine the effectiveness of moxidectin compared to ivermectin once or twice a year in maintaining undetectable levels, or reducing levels, of skin microfilaria.

Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

This study will investigate the safety and effectiveness of combination regimens in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.

Integrating Mental Health Into Neglected Tropical Disease Care in Ghana

Background Neglected Tropical Diseases (NTDs) are a group of diseases that are more common among the poorest people in the poorest countries. People affected by these conditions often experience pain, changes in their physical appearance, stigma and discrimination. As a result, they are more likely to experience mental distress including depression and anxiety. It is important that people affected by these conditions are found early, so that they can start treatment to stop the progression of the condition and to support their mental wellbeing. The World Health Organisation recently developed guidance that explains more about including mental health awareness and care as part of the management of people who have these conditions. This is called the Essential Care Package for NTDs, Stigma and Mental Health Conditions. However, so far there has been limited research about 'what works' when providing this package to people who need it. Aim of the study Through this study, we aim to understand 'How can the health system in Ghana provide the essential care package for people affected by skin NTDs for large groups of the population (at scale)?; and how to do this in a way that means everyone can access it (that is fair) and that is effective (works well)?' Methods/ Design In order to do this, we will develop a Ghanaian version of the Essential Care Package and associated resources to support its implementation. We will do this by including people affected by NTDs to help us understand the needs and priorities from their perspective. Working together with researchers, health workers and those who make decisions about health, people affected will be supported to identify their priorities and to take part in developing what will be included in this Ghanaian ECP. This will happen by using creative forms of research that encourage people to participate and through the process, with workshops to include their opinions scheduled throughout. Once this has been developed the Government will then start to introduce the Ghanaian ECP in selected study districts. At the same time, we will monitor and evaluate what is happening to understand what parts work well? who they work best for? in what settings? and for how long? We will carry out different types of research to understand who has access to this new package of services? (how fair is it?), how well it works? How the health workers and health system take up and use the new ECP? How the new ECP is rolled out and introduced as part of the health system? And whether it can be maintained and continue beyond the end of the study? Discussion Through this study, we hope that people affected by NTDs and mental health conditions will be able to access and use quality health services when they need them; that communities will have a better understanding about NTDs and mental health conditions; and that government departments will work better together to provide care for NTDs and mental health conditions together.

Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases

This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the region, including intestinal worms (soil-transmitted helminths) and scabies. The trial aims to answer the following key questions: * How do moxidectin and ivermectin compare in reducing the prevalence (how common the disease is) and intensity (amount of parasites per person) of onchocerciasis in the community? * Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies? * Does moxidectin reduce transmission of onchocerciasis more effectively than ivermectin, based on genetic testing of parasites in people and lab testing of the blackflies that carry the infection? * How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling? * How do communities feel about receiving moxidectin versus ivermectin, and what factors help or make it harder to carry out MDA programs with moxidectin versus ivermectin? The study takes place in Bié Province, Angola, and involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Prior to every round of MDA, researchers will collect skin, stool and blood samples from a sample of the people living in the study area. We believe the results will help guide global policy on the use of moxidectin in efforts to eliminate onchocerciasis and control related diseases.

Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination

Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission. To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected. At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs.

Emodepside Phase II Trial for Treatment of Onchocerciasis

The trial evaluates safety, tolerability, pharmacodynamics, pharmacokinetics, dose-response, and efficacy of emodepside tablets, administrated as a range of dose regimens, in adults infected with Onchocerca Volvulus.