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

March 25, 2026 updated by: Farida Selmouni, International Agency for Research on Cancer

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Carcassone, France, 11000
        • Recruiting
        • Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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

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.
No Intervention: Control group
Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after postal mail
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.
1 year after postal mail
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.
Month 36 - Month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Collaborators

Centre Régional de Coordination des Dépistages des Cancers, centre-Carcassonne
Université de Bretagne Occidentale, Brest-France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 18, 2026

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC 21-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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