Clinical trial · Interventional
Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)
Prevention and Screening Intervention Project - Towards Elimination of Cervical Cancer: Validation of Artificial Intelligence as Decision Support System in VIA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervix Cancer | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Validation of AI-DSS in Bangladesh | Diagnostic Test | — | UNRESOLVED |
| Validation of AI-DSS in India | Diagnostic Test | — | UNRESOLVED |
| Validation of AI-DSS in Uganda | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AI-DSS validation Bangladesh
- description
- 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.
- interventionNames
- Diagnostic Test: Validation of AI-DSS in Bangladesh
- type
- EXPERIMENTAL
- label
- AI-DSS validation Uganda
- description
- 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.
- interventionNames
- Diagnostic Test: Validation of AI-DSS in Uganda
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSultanov M, Zeeuw J, Koot J, der Schans JV, Beltman JJ, Fouw M, Majdan M, Rusnak M, Nazrul N, Rahman A, Nakisige C, Rao AP, Prasad K, Guruvare S, Biesma R, Versluis M, de Bock GH, Stekelenburg J. Investigating feasibility of 2021 WHO protocol for cervical cancer screening in underscreened populations: PREvention and SCReening Innovation Project Toward Elimination of Cervical Cancer (PRESCRIP-TEC). BMC Public Health. 2022 Jul 15;22(1):1356. doi: 10.1186/s12889-022-13488-z. PMID 35840949
- BACKGROUNDNakisige C, de Fouw M, Kabukye J, Sultanov M, Nazrui N, Rahman A, de Zeeuw J, Koot J, Rao AP, Prasad K, Shyamala G, Siddharta P, Stekelenburg J, Beltman JJ. Artificial intelligence and visual inspection in cervical cancer screening. Int J Gynecol Cancer. 2023 Oct 2;33(10):1515-1521. doi: 10.1136/ijgc-2023-004397. PMID 37666527