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

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.

Conditions

• HPV Infection
• Cervix Cancer
• Cervical Dysplasia

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.

Sponsors & Collaborators

• Uganda Cancer Institute

  collaborator OTHER

• Female Cancer Foundation

  collaborator UNKNOWN

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Manipal Academy for Higher Education

  collaborator UNKNOWN

• Friendship Bangladesh

  collaborator UNKNOWN

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Jelle Stekelenburg, MD, PhD · University Medical Center Groningen

• Janine de Zeeuw, PhD · University Medical Center Groningen

• Jogchum Beltman, MD, PhD · Female Cancer Foundation

• Keerthana Prasad, PhD · Manipal Academy for Higher Education

• Carol Nakisige, MD · Uganda Cancer Institute

• Aminur Rahman Shaheen, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• Uganda

Study Locations