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

Cervical Cancer Clinical Trial

— AppDate-You  

Official title:

Artificial Intelligence-assisted Decision-making to Improve Women's Participation to Cervical Cancer Screening in Occitanie Region-France

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05286034
• Other study ID #: IEC 21-16
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: International Agency for Research on Cancer
• Contact: Farida Selmouni, Dr
• Phone: + 33 4 72 73 84 99
• Email: selmounif[@]iarc.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

Inclusion criteria: eligible women will be:

• aged 30-65
• did not perform a pap smear in the last 4 years
• are living in deprived clusters in the Occitanie region.
• did not answer to a first "invitation" letter to perform a clinician-collected HPV testing

Exclusion criteria: ineligible women will be those:

• outside the target age group
• had a Pap smear in the past 3 years
• had hysterectomy including cervix
• are pregnant beyond 6 months
• already scheduled a screening appointment or had just attended a HPV screening
• had a cervical abnormality that was under exploration and/or treatment.
• participated to the study pilot

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
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.

Locations

Country	Name	City	State
France	Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie	Carcassone

Sponsors (3)

Lead Sponsor	Collaborator
International Agency for Research on Cancer	Centre Régional de Coordination des Dépistages des Cancers, centre-Carcassonne, Université de Bretagne Occidentale, Brest-France

Country where clinical trial is conducted

France, 

References & Publications (1)

Selmouni F, Guy M, Muwonge R, Nassiri A, Lucas E, Basu P, Sauvaget C. Effectiveness of Artificial Intelligence-Assisted Decision-making to Improve Vulnerable Women's Participation in Cervical Cancer Screening in France: Protocol for a Cluster Randomized Controlled Trial (AppDate-You). JMIR Res Protoc. 2022 Aug 2;11(8):e39288. doi: 10.2196/39288. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year after postal mail
Primary	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.	1 year after postal mail
Primary	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.	Month 36 - Month 48