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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-08-18

Brief Summary

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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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Detailed Description

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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

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Cervical Cancer Screening Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes