Menu
Recruiting NCT05286034

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

No phase Interventional Cervical Cancer Screening Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision aid tailored to women with lower educational attainment,accessible via artificial intelligence-based Chatbot platforms.
Who it may be relevant to
Registry conditions: Cervical Cancer Screening, Cervical Cancer. Basic parameters: 30 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • HPV self-sampling "return" rate [Time frame: 1 year after postal mail]
  • Proportion of HPVss-positive women "well managed" [Time frame: 1 year after postal mail]
  • Cost and cost-efficacy [Time frame: Month 36 - Month 48]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie — Carcassone

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. PMID 35771872

Identifiers

NCT: NCT05286034 · IEC 21-16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗