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

Last updated: April 1, 2025
Sponsor: University Medical Center Groningen
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cervical Dysplasia

Cervical Cancer

Uterine Disorders

Treatment

Validation of AI-DSS in Bangladesh

Validation of AI-DSS in India

Validation of AI-DSS in Uganda

Clinical Study ID

NCT06452004
2022300195
  • Ages 30-60
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Clinical signs of cervical carcinoma

  • Menstruation or other vaginal blood loss

  • HPV negative women

Study Design

Total Participants: 600
Treatment Group(s): 3
Primary Treatment: Validation of AI-DSS in Bangladesh
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Mpasana

    Kakumiro,
    Uganda

    Site Not Available

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