Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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.

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.

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

Farida Selmouni, Dr

Marine Guy, MD

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.

A cluster randomized controlled trial with two arms (one experimental arm and one active control arm) will be conducted in the Occitanie region, France to assess the effectiveness of a decision aid accessible via artificial intelligence-based Chatbot platforms to improve the "return" rate of HPV self-samples and the proportion of invited women "well managed" among disadvantaged women. A cluster is defined by aggregated units for statistical information (Ilots Regroupés pour l'Information Statistique, IRIS) and it refers to a target size of 2000 inhabitants per unit. Only IRIS classified as 4 and 5 according to the French version of the European Deprivation Index (EDI) will be included. The study will be conducted as a two-armed nested into the French cervical cancer screening programme in the Occitanie Region. Clusters will be randomly assigned by a computer-generated randomized schedule following simple randomization procedures in a 1:1 ratio.

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

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

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme	NCT05286034	Cervical Cancer... Cervical Cancer	Decision aid ta...	30 Years - 65 Years	International Agency for Research on Cancer
Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme	NCT05286034	Cervical Cancer... Cervical Cancer	Decision aid ta...	30 Years - 65 Years	International Agency for Research on Cancer
Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme	NCT05286034	Cervical Cancer... Cervical Cancer	Decision aid ta...	30 Years - 65 Years	International Agency for Research on Cancer

Spots Global Cancer Trial Database for cluster randomized controlled trial