[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"onchocerciasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:onchocerciasis":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,70,94,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":40,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100631921","early-detection-and-ai-based-management-of-skin-related-neglected-tropical-diseases-in-sub-saharan-africa-by-frontline-health-workers-100631921",false,"NCT07506967","Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers","Early Detection and Management of SKIN-related negleCted Tropical Diseases Using Artificial Intelligence in Sub-saharan afRica (SkincAIr)","SkincAIr","1. Frontline Health Workers (FHWs) Age Group\n\n   * Age Range: 18 years and above o Justification: FHWs must be adults, legally eligible to provide healthcare services and consent to participate in the study Sex Distribution\n   * Male and Female FHWs o Justification: Both male and female FHWs will be included to reflect the actual workforce distribution and to ensure generalizability of the results across genders.\n\n   Inclusion criteria for FHWs:\n   1. Professional Role:\n\n      o Must be working as a FHW at one of the selected health centers at the time of the validation study.\n\n      ▪ Justification: The study aims to assess the diagnostic performance of those directly involved in primary patient care in the targeted settings.\n   2. Willingness to Participate:\n\n      o Willing to provide written informed consent to participate in the study.\n\n      ▪ Justification: Ethical standards require voluntary participation with informed consent.\n   3. Smartphone Usage:\n\n      o Willing and able to use a smartphone during the study.\n\n      ▪ Justification: The SkincAIr app is smartphone-based; therefore, FHWs must be willing to use and have access to such devices.\n   4. No Specialized Dermatology Training:\n\n      * FHWs without specialised training in dermatology or extensive experience in skin disease diagnosis.\n\n        * Justification: The study aims to evaluate the app's effectiveness among generalist healthcare workers who would benefit most from diagnostic support tools.\n\n   Exclusion criteria for FHWs:\n\n   1\\. Prior Specialised Training in dermatology:\n\n   o FHWs with formal education or extensive experience in dermatology.\n   * Justification: Including specialists could skew results, as their baseline diagnostic accuracy may already be high, reducing the observable impact of the app.\n\n     2\\. Refusal or Inability to Consent:\n     * FHWs unwilling or unable to provide written informed consent.\n   * Justification: Ethical compliance requires informed consent for participation. 3. Inability to Use the App: o FHWs unable to use a smartphone due to technical limitations, physical impairments, or lack of familiarity with the technology.\n   * Justification: Effective use of the app is essential for the intervention; inability to use it would prevent meaningful participation.\n2. Patients with Skin complaints Size\n\n   ● Total Patients: \\~750 patients Age Group\n\n   ● All Age Groups:\n\n   o Justification: Skin-NTDs affect individuals of all ages; including all age groups enhances the generalizability of the findings and assesses the app's effectiveness across the lifespan.\n\n   Sex Distribution\n   * Male and Female Patients\n   * Justification: Both sexes are included to capture the full spectrum of the disease burden and ensure the app's diagnostic accuracy is effective regardless of sex.\n\n   Inclusion Criteria for Patients with Skin complaints:\n\n   1\\. Presenting with Skin Complaints:\n\n   o Patients presenting to participating health centres with symptoms suggestive of skin-NTDs (e.g., visible skin lesions, nodules, ulcers) but have not been diagnosed by a specialist for that specific skin condition.\n   * Justification: The study aims to evaluate the app's effectiveness in real-world conditions, including all patients with potential skin-NTDs 2. Willingness to Participate: o Patients (or guardians, in the case of minors) willing to provide written informed consent for participation.\n   * Justification: Ethical standards require informed consent from patients or their legal guardians.\n\n     3\\. Ability to Comply with Study Procedures:\n\n     o Patients are able to follow study instructions and attend necessary follow-up appointments.\n   * Justification: Ensures complete data collection and accurate assessment of outcomes.\n\n     4\\. Patients with Co-morbid conditions:\n   * Justification: Immunosuppression that occurs in some comorbid conditions e.g. HIV\u002FAIDS or severe malnutrition can reveal the Skin disease and can affect both the clinical progression and even severity of the Skin NTD. This also includes patients with multiple skin-NTDs.\n\n   Exclusion Criteria for Patients with Skin complaints:\n   1. Refusal or Inability to Consent:\n\n      o Patients (or guardians) unwilling or unable to provide written informed consent.\n\n      ▪ Justification: Ethical compliance requires informed consent for participation.\n   2. Non-Skin-Related Complaints:\n\n      o Patients presenting with complaints unrelated to skin conditions.\n\n      ▪ Justification: The study focuses on skin-NTDs; including unrelated cases would not contribute to the study objectives.\n   3. Previous Participation in the Study:\n\n      o Patients who have already participated in the study.\n\n      ▪ Justification: To avoid duplicate data and potential bias in outcomes.\n\n      Additional Considerations:\n\n      Diversity and Representation ● Geographical Diversity:\n\n      o Including health centres from different regions within each country ensures that the findings are representative of various settings (urban, peri-urban, rural).\n\n      ● Cultural and Socioeconomic Factors:\n\n      o The study acknowledges that cultural beliefs and socioeconomic status may influence healthcare-seeking behaviour and disease presentation. By including a diverse patient population, the study aims to capture these variations.\n\n      Ethical Justification ● Inclusivity:\n      * Including all age groups and both sexes aligns with ethical principles of justice and fairness, ensuring that the benefits of the research are accessible to all segments of the population.\n\n        * Vulnerable Populations:\n      * While including minors and potentially vulnerable adults, the study will implement additional safeguards to protect their rights and well-being, following ethical guidelines and obtaining consent from guardians when necessary.","ALL","0 Years",{"count":20,"type":21},2420,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Skin and Connective Tissue Diseases","Neglected Tropical Diseases","Leprosy","Buruli Ulcer","Cutaneous Leishmaniasis","Scabies","Mycetoma","Lymphatic Filariasis","Onchocerciasis","Tungiasis","Post Kala-Azar Dermal Leishmaniasis","Yaws","Podoconiosis",[41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Skin-related neglected tropical diseases","Artificial Intelligence","Mobile Health","mHealth","Frontline Health Workers","Diagnostic Accuracy","Sub-Saharan Africa","Skin NTDs","Digital Health","AI Diagnostic Tool","Capacity Building","Kenya","Ethiopia","Senegal","Nigeria","Democratic Republic of the Congo","NOT_YET_RECRUITING","2026-03-27",{"date":60,"type":61},"2026-04-02","ACTUAL",{"date":63,"type":21},"2026-05-01",{"date":65,"type":21},"2030-05-31",{"name":67,"class":68},"Kenya Medical Research Institute","OTHER",5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100612044","integrating-mental-health-into-neglected-tropical-disease-care-in-ghana-100612044","NCT07248462","Integrating Mental Health Into Neglected Tropical Disease Care in Ghana","Integrating Mental Health and Neglected Tropical Disease Interventions to Support Equitable People-Centred Care in Ghana","IMAGINE","Inclusion Criteria:\n\n* Affected by one of the target NTDs (leprosy, LF, buruli Ulcer, Yaws, Onchocersiasis)\n* Living in one of the intervention areas (Bole, Ho, Hohoe, Ellembele)\n* Aged 18 years and above\n\nExclusion Criteria:\n\n\\-","18 Years",{"count":80,"type":21},200,[24],"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.\n\nAim 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)?'\n\nMethods\u002F 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.\n\nOnce 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?\n\nDiscussion 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.",[29,84,30,35,38],"Lymphatic Filariases","2025-11-18",{"date":87,"type":61},"2025-11-25",{"date":89,"type":21},"2025-11",{"date":91,"type":21},"2027-02",{"name":93,"class":68},"Liverpool School of Tropical Medicine",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":17,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100604147","phase-4-moxidectin-versus-ivermectin-as-mass-drug-administration-for-the-control-of-onchocerciasis-and-other-neglected-tropical-diseases-100604147","NCT07145736","Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases","Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised Trial","EKAIO","Inclusion Criteria:\n\n* Male or female children and adults\n* Residents in the villages selected for MDA treatment\n\nExclusion Criteria:\n\n* Arm 1 (ivermectin): children under the age of 5 and\u002For under 90 cm of height\n* Arm 2 (moxidectin): children under the age of 12 years (who will receive ivermectin if they are at least 90 cm in height\u002F5 years of age and above).\n* Arm 1 (ivermectin): Women breast-feeding babies under 45 days of age\n* Arm 2 (moxidectin): All breastfeeding women (who will be offered ivermectin if their infants is at least 45 days old)\n* Know allergy to ivermectin or moxidectin\n* Attending other clinical trials during the study\n* Pregnant\n* Arm 2 (moxidectin): Women planning to become pregnant in the 3 months post-treatment\n* Refusal to receive one or both study drugs, i.e. participants in villages allocated to receive moxidectin who refuse to receive moxidectin will be given the option to receive ivermectin; if they refuse to receive both drugs they will be excluded from the MDA altogether\n* Has an illness that makes them too sick or weak to get out of bed\n* Currently hospitalized",true,"5 Years",{"count":105,"type":21},52000,[107],"PHASE4","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.\n\nThe trial aims to answer the following key questions:\n\n* 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?\n* Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies?\n* 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?\n* How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling?\n* 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?\n\nThe 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.",[35,110,111,112,32],"Ascaris Lumbricoides Infection","Trichuris Trichiura; Infection","Hookworm Infections","RECRUITING",{"date":115,"type":61},"2025-11-21",{"date":117,"type":61},"2025-08-04",{"date":119,"type":21},"2029-06-30",{"name":121,"class":122},"Kirby Institute","OTHER_GOV",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":102,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":123},"100543052","development-of-a-new-rapid-diagnostic-test-to-support-onchocerciasis-elimination-100543052","NCT06350851","Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination","Obi1","Inclusion Criteria:\n\n* Subjects informed of the objectives of the study and who signed a consent form\n* Subjects without filariasis (for control subjects), or\n* Subjects mono-infected with Onchocerca volvulus, or\n* Subjects mono-infected with Loa loa, or\n* Subjects mono-infected with Mansonella perstans or alternatively co-infected with Mansonella perstans and Loa loa\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Subjects having taken antihelminthic treatment less than 6 months before the inclusion date",{"count":132,"type":21},400,[24],"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.\n\nTo 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.\n\nAt 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.",[35,136,137,138],"Loiasis","Mansonelliasis","Healthy Volunteers",[140,141,142,143,28],"Onchocerca volvulus","Loa loa","Mansonella perstans","Biplex Rapid Diagnostic Test","2025-03-05",{"date":146,"type":61},"2025-03-07",{"date":148,"type":61},"2024-04-15",{"date":150,"type":21},"2025-12",{"name":152,"class":68},"Bioaster"]