Clinical trial Recruiting at 1 site Interventional Ages 30 to 65 Women only

AI chatbot plus home HPV self-sampling to boost cervical screening participation

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

Run by International Agency for Research on Cancer · NCT05286034 · Data updated 2026-11-12

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

Study typeInterventional
Ages30 Years to 65 Years
SexWomen only
Enrollment3000 (estimated)
SponsorInternational Agency for Research on Cancer
Academic / other
Locations1 site (Carcassone)
StatusRecruiting
StartedNovember 3, 2025
Main results expectedJuly 31, 2026
Study endsAugust 18, 2026
Registry record updatedMarch 27, 2026
Trial IDNCT05286034 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Centre Régional de Coordination des Dépistages des Cancers-Centre d'Occitanie
    Carcassone, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.