Cervical Cancer ScreeningAppDate-YouNCT05286034
Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme
A study testing Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms in people with Cervical Cancer Screening and Cervical Cancer, run by International Agency for Research on Cancer at 1 site in France.
Trial summary
This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening, Cervical Cancer
- What is being tested?
- Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2025to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
Carcassone, 11000
Bernard VALENTIN, MD, +33 4 68 72 72 00, B.Valentin@depistage-occitanie.fr
About this study
Official title: 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.
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.
- Conditions
- Cervical Cancer Screening, Cervical Cancer
- Being tested
- Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms
- Keywords
- cervical neoplasia, cervical cancer screening, chatbot, artificial intelligence, cluster randomized controlled trial, HPV vaginal self-sampling
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platformsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms |
| Control group | No intervention | Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after postal mail
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.
Measured: 1 year after postal mail
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.
Measured: Month 36 - Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start3 Nov 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Université de Bretagne Occidentale, Brest-France
- Responsible party
- Principal investigator, Farida Selmouni, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286034
- Sponsor's protocol ID
- IEC 21-16
- Acronym
- AppDate-You
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Decision-making to Improve Women's Participation to Cervical Cancer Screening in Occitanie Region-France
- ClinicalTrials.gov ID
- NCT05286034
- Acronym / sponsor ID
- AppDate-You / IEC 21-16
- Conditions
- Cervical Cancer Screening, Cervical Cancer
- Keywords
- cervical neoplasia, cervical cancer screening, chatbot, artificial intelligence, cluster randomized controlled trial, HPV vaginal self-sampling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Université de Bretagne Occidentale, Brest-France
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project looks to improve the return rate of HPV self-sampling (HPVss) as well as the management of women HPVss positive.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platformsWomen 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. |
| Control group | No intervention | –Women randomized to this group will be sent screening reminder letters to perform HPV self-sampling test (Standard care) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platformsNon-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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 35771872Selmouni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms in people with Cervical Cancer Screening and Cervical Cancer, run by International Agency for Research on Cancer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farida Selmouni, Dr (+ 33 4 72 73 84 99, selmounif@iarc.who.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV self-sampling "return" rate (time frame: 1 year after postal mail). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.