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NCT Number: NCT05286034

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

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

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Carcassone, 11000, France

Location status: Recruiting

Location contact

Bernard VALENTIN, MD

CONTACT

[email protected]

+33 4 68 72 72 00

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. HPV self-sampling "return" rate

    Time frame: 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.

  2. Proportion of HPVss-positive women "well managed"

    Time frame: 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.
  3. Cost and cost-efficacy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Farida Selmouni, Dr

CONTACT

[email protected]

+ 33 4 72 73 84 99

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • National Cancer Institute, France
  • Université de Bretagne Occidentale, Brest-France

Registry information

Official study title

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

Acronym: AppDate-You

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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