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ACTIVE NOT RECRUITING
NCT06452004
NA

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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.

Official title: Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer: Validation of Artificial Intelligence as Decision Support System in VIA

Key Details

Gender

FEMALE

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2022-10-01

Completion Date

2025-12-31

Last Updated

2025-04-04

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Validation of AI-DSS in Bangladesh

VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.

DIAGNOSTIC_TEST

Validation of AI-DSS in Uganda

VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.

DIAGNOSTIC_TEST

Validation of AI-DSS in India

VIA procedure, taking pre-colouring and post-colouring pictures. First VIA assessment by health worker, followed by AI-DSS assessment. Independent panel of gynaecologists also assessed pictures. The panel assessment serves as reference value to calculate accuracy, sensitivity and specificity of health worker and AI-DSS.

Locations (1)

Mpasana

Kakumiro, Uganda