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

April 1, 2025 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kakumiro, Uganda
        • Mpasana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-DSS validation 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.
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.
Experimental: AI-DSS validation 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.
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.
Experimental: AI-DSS validation 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy, sensitivity, specificity of AI-DSS
Time Frame: 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
through study completion, estimated 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of quality pictures
Time Frame: 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
through study completion, estimated 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
User-friendliness of AI-DSS device among healthcare providers
Time Frame: through study completion, estimated 2 years
Scoring on Likert scale by healthcare providers using AI-DSS device based on their assessment of device software human machine interface, weight, size, flashlight,
through study completion, estimated 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh
Uganda Cancer Institute
Manipal Academy for Higher Education
Female Cancer Foundation
Friendship Bangladesh

Investigators

  • Principal Investigator: Janine de Zeeuw, PhD, University Medical Center Groningen
  • Principal Investigator: Aminur Rahman Shaheen, PhD, International Centre for Diarrhoeal Disease Research, Bangladesh
  • Principal Investigator: Jelle Stekelenburg, MD, PhD, University Medical Center Groningen
  • Principal Investigator: Jogchum Beltman, MD, PhD, Female Cancer Foundation
  • Principal Investigator: Keerthana Prasad, PhD, Manipal Academy for Higher Education
  • Principal Investigator: Carol Nakisige, MD, Uganda Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022300195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sharing according to the European Union Open Research guidelines

IPD Sharing Time Frame

After 1 January 2024

IPD Sharing Access Criteria

As per Open Research Protocol, on request to Principal Investigator UMCG

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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