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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorKenya Medical Research Institute

About this trial

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 In the final 6 months (Phase C), the app is withdrawn to assess whether FHWs retain their improved diagnostic skills.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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Frontline Health Workers (FHWs) Age Group

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

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.

FHWs without specialised training in dermatology or extensive experience in skin disease diagnosis.

Disqualifiers

Justification: Including specialists could skew results, as their baseline diagnostic accuracy may already be high, reducing the observable impact of the app.

FHWs unwilling or unable to provide written informed consent.

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.

Justification: Effective use of the app is essential for the intervention; inability to use it would prevent meaningful participation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • A mobile app with AI functionality for diagnosing skin-related NTDs

    Device

    The SkincAIr Research App is a unified mobile platform (Android, offline-capable) containing three role-specific modules: (1) Dermatologist Dataset eCRF - used by dermatologists in 5 countries (M12-M48) to capture and annotate high-quality clinical images of skin NTDs for AI model development; (2) FHW eCRF - used by frontline health workers (FHWs) in 3 countries (M22-M45) to document clinical assessments with and without AI support; (3) SkincAIr Detection App - an AI-powered diagnostic decision-support feature embedded within the FHW eCRF, activated exclusively during Phase B (6 months), providing image-based diagnostic suggestions to assist FHWs in identifying skin NTDs. The SkincAIr Detection App is the primary intervention under validation. If proven effective, it is intended for adoption by National Ministries of Health, integration into national Health Information Systems (DHIS2), and scale-up across sub-Saharan Africa.

Treatment groups

2,420 Participants
are divided into 2 treatment groups
Group A: Clinical Image Data CollectionOther 1 intervention
Group B: SkincAIr Validation Study - Frontline Health WorkersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

FHW Diagnostic Accuracy Improvement (FHW-DAI)

Percentage improvement in diagnostic accuracy of frontline health workers (FHWs) when using the SkincAIr Detection App compared to baseline performance without the app. Diagnostic accuracy is measured by comparing FHW diagnoses against the reference standard diagnosis established independently by a co-located dermatologist for each patient case. A minimum improvement of 15% (KPI 1.3) is required to demonstrate clinical utility of the app. Measured across all 3 study phases: Phase A (baseline, no app, M22-M33); Phase B (app active, M34-M39); Phase C (app withdrawn, M40-M45).

Time frame
Month 22 through Month 45

Secondary outcomes

1

Early Detection Rate of Skin NTDs by FHWs (KPI 1.1)

Percentage increase in early-stage skin NTD case detection by frontline health workers (FHWs) compared to baseline. Early detection is defined as FHW identification of a skin NTD case at an early disease stage, confirmed by the reference dermatologist. A minimum increase of 12% at 6 months of app use (Phase B) is required (KPI 1.1). Measured by comparing the proportion of early-stage confirmed cases detected by FHWs across Phase A (baseline) and Phase B (app active).

Time frame
22 through Month 39
2

Time Reduction from FHW Suspicion to Diagnostic Confirmation (KPI 1.2)

Reduction in time (days) from the moment a FHW suspects a skin NTD to external diagnostic confirmation by a dermatologist. A reduction of more than 10% compared to baseline (Phase A) is required (KPI 1.2). Measured using timestamps recorded in the FHW eCRF across all 3 study phases.

Time frame
Month 22 through Month 45
3

Sensitivity of FHW Diagnosis for Skin NTDs (KPI 1.4)

True Positive Rate of FHW diagnoses for skin NTDs, defined as the proportion of confirmed skin NTD cases correctly identified by FHWs. A minimum sensitivity of 80% for at least 7 skin NTD categories is required (KPI 1.4). Measured by comparing FHW diagnoses against the dermatologist reference standard across all study phases.

Time frame
Month 22 through Month 45
4

Specificity of FHW Diagnosis for Skin NTDs (KPI 1.5)

True Negative Rate of FHW diagnoses for skin NTDs, defined as the proportion of non-skin NTD cases correctly excluded by FHWs. A minimum specificity of 80% for at least 7 skin NTD categories is required (KPI 1.5). Measured by comparing FHW diagnoses against the dermatologist reference standard across all study phases.

Time frame
Month 22 through Month 45

Other outcomes

1

Skin NTD Image Dataset Size and Quality (KPI 2.1-2.4)

Total number of high-resolution annotated skin NTD images collected by dermatologists across 5 countries using the Dermatologist Dataset eCRF module of the SkincAIr Research App. Targets: \>3,500 images total (KPI 2.1); geographic diversity across \>4 countries (KPI 2.2); \>100 images of 11 skin NTD categories (KPI 2.3); \>90% of images meeting predefined quality standards (KPI 2.4).

Time frame
Month 12 through Month 48

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kenya Medical Research Institute

Lead sponsor

Universidad Politecnica de Madrid

Collaborator

FACHHOCHSCHULE ZENTRALSCHWEIZ - HOCHSCHULE LUZERN

Collaborator

SHERWOOD HEALTHCARE SENEGAL SARL

Collaborator

King's College London

Collaborator

TEACUP CONSULTING SL

Collaborator

MTU AUSTRALO ALPHA LAB

Collaborator

OMODI, AGASNA, ODIEMBO ADVOCATES LLP

Collaborator

OEUVRES HOSPITALIERES FRANCAISES DE L'ORDRE DE MALTE

Collaborator

Armauer Hansen Research Institute, Ethiopia

Collaborator

Leprosy and Tuberculosis Relief Initiative Nigeria

Collaborator

UNIVERSITE CATHOLIQUE DE BUKAVU

Collaborator

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