An interventional study of Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms in Cervical Cancer Screening and Cervical Cancer, sponsored by International Agency for Research on Cancer. Recruiting at 1 site in France. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by International Agency for Research on Cancer · Not applicable, Interventional, and Screening
This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →International Agency for Research on Cancer is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria: eligible women will be:
Exclusion criteria: ineligible women will be those:
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test, with access to a decision aid tool tailored to those with low education levels. This tool will be available via Chatbot platforms.
Behavioral: Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care)
Non-compliant women those that have not been screened for more than 4 years and living in the disadvantaged areas will be sent screening reminder letters to perform HPV self-sampling (HPVss) test, with access to decision aid tailored to women with lower education attainment and available via Chatbot platforms. ChatBot will deliver information in a responsive, conversational way via text and spoken language in multiple languages through multiple mobile channels.
HPV self-sampling "return" rate
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.
Time frame: 1 year after postal mail
Proportion of HPVss-positive women "well managed"
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.
Time frame: 1 year after postal mail
Cost and cost-efficacy
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.
Time frame: Month 36 - Month 48
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Jul 2026, 8 months after the start.
Of 445 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 71. This study's planned 8 months is below that.
Counting every sponsor, half of 461 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
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International Agency for Research on Cancer