Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)

Not Applicable

Active, not recruiting

• Conditions: Cervical Dysplasia; HPV Infection; Cervix Cancer
• Interventions: Diagnostic Test: Validation of AI-DSS in Uganda; Diagnostic Test: Validation of AI-DSS in India; Diagnostic Test: Validation of AI-DSS in Bangladesh

• Registration Number: NCT06452004
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The research project is a component of another research project that applies the protocol of the World Health Organization for screening of cervical cancer, with testing of high-risk Human Papilloma Virus (hrHPV) as first screening. In the screen, triage and treat approach women who tested positive for hrHPV are undergoing Visual Inspection of the cervix with Acetic Acid (VIA). This procedure is applied in Uganda, India and Bangladesh. However the quality of VIA by lower-trained staff is variable because Low and Middle Income Countries face limited numbers of qualified health care professionals. Artificial intelligence (AI) might be a solution to improve consistency of VIA assessment. This research validates an AI decision support system (AI-DSS) under field conditions.

Detailed Description

This research project aims to validate an image processing algorithm in order to study if the AI can function as decision support system (DSS) for healthcare workers, who perform VIA. The AI-DSS has been designed by the Manipal Academy of Higher Education in India and has shown a sensitivity of 99.05% and specificity of 97.16% for detection of aceto-white lesions.

The first step of the validation process is a dry run using a database of VIA pictures with pathology confirmation. The accuracy, sensitivity and specificity of healthcare workers, an expert team and the AI will be analysed, based on the ground truth of database pictures.

Thereafter, the AI-DSS will be validated under field conditions. Women who are hrHPV-positive in Uganda, India and Bangladesh will undergo a VIA. The AI is incorporated in a device, that can take pictures of the cervix and provide and instant report (positive = needs further investigation or negative = no lesions found). The user experience of the device will be evaluated.

The AI-DSS will be validated by comparing the VIA assessment by health workers, the AI with assessment by the expert panel. Accuracy, sensitivity and specificity of the AI algorithm will be assessed.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-10-26
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-11
• Primary Completion: 2024-12-31
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Female in eligible age group
• Women who tested HPV positive and are eligible for VIA
• Ability to give informed consent and participate in study

Exclusion Criteria

• Clinical signs of cervical carcinoma
• Menstruation or other vaginal blood loss
• HPV negative women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI-DSS validation Uganda	Validation of AI-DSS in Uganda	Women in selected intervention area in Uganda, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.
AI-DSS validation India	Validation of AI-DSS in India	Women in selected intervention area in India, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.
AI-DSS validation Bangladesh	Validation of AI-DSS in Bangladesh	Women in selected intervention area in Bangladesh, who tested hrHPV-positive eligible for VIA, are included. VIA is performed. During VIA the health worker performs an assessment. With the device a picture and taken and AI-DSS generates and assessment as well. The pictures are also assessed by an expert panel.

Primary Outcome Measures

Name	Time	Method
Accuracy, sensitivity, specificity of AI-DSS	through study completion, estimated 2 years	Measurement of true and false positive and true and false negative results of the AI DSS in relation to assessment by expert panel

Secondary Outcome Measures

Name	Time	Method
Percentage of quality pictures	through study completion, estimated 2 years	Percentage of pictures taken during the VIA procedures, which meet according to the expert panel the quality standards suitable for AI-DSS assessment, based on visibility of cervix and Squamo-Columnar Junction (SCJ), light, reflection of speculum, mucus-free surface

Trial Locations

Locations (1)

Mpasana; 🇺🇬 Kakumiro, Uganda