Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer; Cervical Cancer Screening

• Registration Number: NCT05286034
• Lead Sponsor: International Agency for Research on Cancer

Brief Summary

This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.

Detailed Description

France has already implemented a cervical screening programme based on HPV test for the whole female population aged 30-65 years. Non-participant women can perform HPV test at their home. However, less than 20% of French women performed vaginal self-sampling when a kit was sent to their home. Women with lower income and educational levels participate less to cervical screening. A variety of personal, practitioner, test-related and logistical barriers negatively impact the screening participation of French women. Key barriers to participation could be addressed by overcoming disparities in HPV-related knowledge and perceptions about cervical cancer screening. This study aims to evaluate the impact of sending HPV self-sampling kit at women's home, associated with providing, through multiple mobile channels, a multi-language decision aid designed for women with lower education accessible via artificial intelligence-based ChatBot. This decision aid will help women review high quality evidence on cervical cancer disease and screening modalities.

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Study Start: 2025-09-15
• Primary Completion: 2026-07-31
• Study Completion: 2026-08-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cost and cost-efficacy	Month 36 - Month 48	Costs will be estimated using an ingredients approach whereby resources used for the respective interventions are identified and valued. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between the intervention groups with the mean difference in effects, and expressed as both euros and US dollars per percentage change in screening participation.
HPV self-sampling "return" rate	1 year after postal mail	Percent of women recalled who "return" HPVss over 12 months "Return" means: 1) the receipt of the vaginal self-sample at the laboratory; 2) the performance of clinician-collected HPV testing for those who prefer to be screened by a health professional; and 3) Information about a recent screening or a cervical screening exclusion reason.
Proportion of HPVss-positive women "well managed"	1 year after postal mail	Percent of recruited women well managed (Percent of women screened and completing full pathway of HPV screening and treatment over 12 months).; "Well managed" is defined as: completed a valid screening test (sample processed successfully to positive or negative result, including recollection of invalid samples) AND; * for HPV negative women, woman advised of negative result; * for HPV positive women, completed assessment.

Trial Locations

Locations (1)

Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie; 🇫🇷 Carcassone, France

Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie

🇫🇷Carcassone, France

Bernard VALENTIN, MD

Contact

+33 4 68 72 72 00

B.Valentin@depistage-occitanie.fr