Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607470386334 Date of Registration: 20/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Catalyzing AI4SkinNTDs: Accelerating equitable Artificial Intelligence use through participatory co-design of SelfCareQA dataset by persons affected by Skin-NTDs (AI4SkinSelfCare)
Official scientific title Catalyzing AI4SkinNTDs: Accelerating equitable Artificial Intelligence use through participatory co-design of SelfCareQA dataset by persons affected by Skin-NTDs (AI4SkinSelfCare)
Brief summary describing the background and objectives of the trial About half of neglected tropical diseases (NTDs) present with cutaneous manifestations, so-called skin-NTDs thus, share similar selfcare morbidity management approaches enabling cost-effective, integrated care as espoused by the WHO. Yet, despite existing guidelines and technical documents for NTDs self-care, their accessibility and adaptability remain limited. Artificial Intelligence (AI) holds huge potential for expanding access to health information and self-care interventions; however, existing AI models are disproportionately trained on data from high-income, western populations rendering current digital health tools less effective and culturally discordant for under-represented groups like people living with skin-NTDs in resource-limited settings. This study aims to develop and validate an evidence-based, culturally competent skin self-care Q&A dataset through participatory co-creation with persons affected by skin-NTDs. The goal is to facilitate equitable, contextually relevant AI health interventions that address their specific lived experience.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Buruli Ulcer, Leprosy, Lymphatic Filariasis,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 27/07/2026
Actual trial start date
Anticipated date of last follow up 27/01/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Participatory Cocreation of a Skin Selfcare QA Dataset 3-months Participants (persons affected by skin-NTDs) will engage in a two-phase participatory co-design intervention to develop a culturally appropriate self-care Q&A dataset. Phase 1 (Active Elicitation): Participants will take part in guided qualitative data collection sessions including Focus Group Discussions (FGDs), In-Depth Interviews (IDIs), and interactive workshops aimed at eliciting their lived experiences, daily challenges, and specific inquiries regarding skin-NTD management to form a foundational question bank. Capacity building sessions for upskilling on digital tools will be held simultaneously. Phase 2 (Iterative Validation): Following the expansion of the question bank via Large Language Models (LLMs) and strict clinical verification by a multidisciplinary physician team, participants will reconvene for iterative validation rounds. During these rounds, participants will review the AI-generated, physician-vetted Q&A content pairs to validate its cultural appropriateness, readability, and practical utility for community or home-based self-care management. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Individuals aged 6 years and older (minors accompanied by consenting parent/guardian) ● Has been confirmed diagnosed with, or possessing verifiable lived experience of either BU, Leprosy, or LF and has been notified to their respective state program ● Resides in southern Nigeria, especially within the study locations, Anambra, Akwa-Ibom or Enugu states ● Depending on the stage of disease, presence of corresponding physical evidence of skin manifestation of the NTD, and/or requires self-care or wound management for their condition ● Able and willing to provide informed consent to participate in the study ● Able and willing to share their personal lived experience of skin-NTDs. Affected persons living with skin-NTDs will be excluded if the individual is hospitalized for experiencing an acute, life-threatening medical emergency or systemic infection that requires immediate clinical attention. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 6 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2026 Health Research and Ethics Committee University of Nigeria Teaching Hospital Ituku Ozalla Enugu
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital UNTH, Ituku-Ozalla, Enugu Enugu 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in self-esteem and internalized stigma scores of the affected persons involved Baseline at pre-intervention, Midpoint at 3-months and Endline at 6-months
Secondary Outcome Change in digital health literacy of the affected persons involved Baseline at pre-intervention, Midpoint at 3-months and Endline at 6-months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AkwaIbom state AkwaIbom State Ministry of Health Uyo 23401 Nigeria
Anambra state Anambra State Ministry of Health Awka 23401 Nigeria
Enugu state Enugu State Ministry of Health Enugu 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
African Research Network for Neglected Tropical Diseases ARNTD ARNTD, KCCR, South-end Asuogya Road, KNUST UPO, PMB, KNUST, Kumasi, Ghana Kumasi Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Research Network for Neglected Tropical Diseases ARNTD ARNTD, KCCR, South-end Asuogya Road, KNUST UPO, PMB, KNUST, Kumasi, Ghana Kumasi Ghana Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Chinwe Eze 15 Cecilia Dike Road, Phase 6, Trans-Ekulu Enugu Nigeria
Ogochukwu Bielonwu ValueDrive Strategic Solutions, Durumi, Abuja FCT Abuja Nigeria
Amaka Onyima Ogbaru LGA, Anambra State TBLCP Ogbaru Nigeria
Dr. Ngozi Ekeke 56 Nza Street, Independence layout, Enugu Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ngozi MurphyOkpala ngozi.murphyo@gmail.com 2348033705461 760 Sentinel Crescent, Durumi, Abuja FCT
City Postal code Country Position/Affiliation
Abuja Nigeria Principal Consultant
Role Name Email Phone Street address
Public Enquiries Daniel Egbule daniel.egbule@redaidnigeria.org +2348036680252 56 Nza Street, Independence layout, Enugu
City Postal code Country Position/Affiliation
Enugu Nigeria CEO RedAid Nigeria
Role Name Email Phone Street address
Scientific Enquiries Ngozi MurphyOkpala ngozi.murphyo@gmail.com +2348033705461 760 Sentinel Crescent Durumi, Abuja FCT
City Postal code Country Position/Affiliation
Abuja Nigeria Principal Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Informed Consent Form Beginning 3 months and ending 2 years following article publication Researchers who provide a methodologically sound proposal may access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 13/07/2026 Thank you for your feedback. The scientific title initially submitted was the working title of the planned study protocol manuscript for journal publication. However, I have now changed it to the same as the public title above which is exactly as it appears in the ethics approval letter. Thank you. Participatory co-design of the SkinSelfCareQA dataset with persons affected by skin-related neglected tropical diseases to advance equitable artificial intelligence use: a study protocol Catalyzing AI4SkinNTDs: Accelerating equitable Artificial Intelligence use through participatory co-design of SelfCareQA dataset by persons affected by Skin-NTDs (AI4SkinSelfCare)