CClinicalTrials.gg
RecruitingNCT05286034AppDate-YouUpdated Mar 27, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cervical Cancer Screening
  • Cervical Cancer

Keywords

  • cervical neoplasia
  • cervical cancer screening
  • chatbot
  • artificial intelligence
  • cluster randomized controlled trial
  • HPV vaginal self-sampling
03

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • 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

  • No intervention
    Control group

    Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care)

Interventions

  • BehavioralDecision 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.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

06

Study locations

1 of 1 sites recruiting
  • Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
    Carcassone, 11000, France
    Recruiting
07

References and documents

Publications

  • 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. PubMed 35771872 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05286034
Lead sponsor
International Agency for Research on Cancer
Collaborators
National Cancer Institute, France, Université de Bretagne Occidentale, Brest-France
Responsible party
Farida Selmouni (Principal Investigator, International Agency for Research on Cancer) — Principal investigator
First posted
Mar 18, 2022
Start date
Nov 3, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Aug 18, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Farida Selmouni, Dr
Contact
selmounif@iarc.who.int
+ 33 4 72 73 84 99

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion