Clinical trial NCT05286034: Using Artificial Intelligence-based ChatBot to Improve Women's Participation to Cervical Cancer Screening Programme
Official title: Artificial Intelligence-assisted Decision-making to Improve Women's Participation to Cervical Cancer Screening in Occitanie Region-France
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer Screening
Cervical Cancer
Keywords: cervical neoplasia
cervical cancer screening
chatbot
artificial intelligence
cluster randomized controlled trial
HPV vaginal self-sampling
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Centre Régional de Coordination des Dépistages des Cancers, centre-Carcassonne
name: Université de Bretagne Occidentale, Brest-France
First posted: 2022-03-18
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief summary: 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.

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 beyond 6 months
* 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

Primary outcomes:
measure: HPV self-sampling "return" rate
timeFrame: 1 year after postal mail
measure: Proportion of HPVss-positive women "well managed"
timeFrame: 1 year after postal mail
measure: Cost and cost-efficacy
timeFrame: Month 36 - Month 48
Secondary outcomes:
Other outcomes:
Locations:
city: Carcassone
country: France
facility: Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
Study officials:
References:
citation: 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.