AI chatbot plus home HPV self-sampling to boost cervical screening participation
Artificial Intelligence-assisted Decision-making to Improve Women's Participation to Cervical Cancer Screening in Occitanie Region-France
This project will try to see if sending HPV self-sampling kits to women aged 30–65 in low-income areas together with a multi-language AI chatbot decision aid increases screening uptake among women who did not respond to an initial invitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | Female |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Carcassone) |
| Trial ID | NCT05286034 on ClinicalTrials.gov |
What this trial studies
This cluster randomized study targets non-responding women aged 30–65 living in deprived clusters of the Occitanie region. Selected clusters will receive mailed HPV self-sampling kits combined with access to a multi-language decision aid delivered via an artificial intelligence-based chatbot on mobile channels, while control clusters receive usual invitation procedures. The primary outcome is return rate of HPV self-sampling; secondary outcomes include follow-up and management of women who test HPV positive. The intervention is tailored for women with lower educational attainment to address knowledge, perception, and logistical barriers to screening.
Who should consider this trial
Good fit: Ideal candidates are women aged 30–65 who live in selected deprived clusters in Occitanie, have not had a Pap smear in the past 4 years, and did not respond to a first invitation to clinician-collected HPV testing.
Not a fit: Women outside the target age range, those recently screened or already scheduled for screening, pregnant women, those with hysterectomy including the cervix, or women currently undergoing evaluation or treatment for cervical abnormalities are not expected to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could raise screening rates and help detect cervical precancers earlier in underserved women, reducing equity gaps in care.
How similar studies have performed: Previous trials have shown that mailed HPV self-sampling kits can increase participation, while multi-language AI chatbot decision aids are a newer, less-tested addition in randomized settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Carcassone
- Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie — Carcassone, France (Recruiting)
Study contacts
- Study coordinator: Farida Selmouni, Dr
- Email: selmounif@iarc.who.int
- Phone: + 33 4 72 73 84 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.