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

NCT05286034 | Recruiting

• 1 other identifier: IEC 21-16
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Cancer Screening; Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Month 36 - Month 48

Study Arms (2)

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.

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)

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Université de Bretagne Occidentale, Brest-France: collaborator
• Centre Régional de Coordination des Dépistages des Cancers, centre-Carcassonne: collaborator

Study Sites (1)

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

Carcassone, 11000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35771872 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Farida Selmouni, Dr

CONTACT

+ 33 4 72 73 84 99; selmounif@iarc.who.int

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: November 3, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 18, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)