HPV self-sampling to boost cervical cancer screening in Marne and Aube
Official title: HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness
Run by International Agency for Research on Cancer · NCT06749847 · Data updated 2026-11-12
This trial tests whether sending HPV self-sampling kits or offering a choice to order one increases screening participation for women aged 30–65 in two French departments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 65 Years |
| Sex | Women only |
| Enrollment | 6000 (estimated) |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 2 sites (Troyes, Aube and 1 other locations) |
| Status | Recruiting |
| Started | June 26, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT06749847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 30 to 65 who live in the Marne or Aube departments and are eligible for the organized screening programme receiving their first invitation in the current screening round are ideal candidates.
✕Probably not a fit
Women outside the 30–65 age range, those with total hysterectomy, a history of cervical cancer, already in the current screening round, or currently under follow-up for abnormal cervical screening are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial enrolls women aged 30–65 in the departments of Marne and Aube and randomizes them to one of three arms: direct mailing of an HPV self-sampling kit with an SMS reminder at 3 months (Outreach), a choice to order a free self-sampling kit or visit a healthcare provider with an SMS reminder at 3 months (Choice), or standard care with the usual reminder schedule (Control). Women who test HPV-positive on self-sampling are referred for triage cytology, with appointment assistance provided in the Outreach arm and a 6-month reminder in the Choice arm. Primary outcomes include participation rates and triage completion, and secondary outcomes include feasibility, acceptability, and cost-effectiveness of the approaches. Results are intended to inform potential changes to the organized national screening program.
Why it matters
Potential benefit: If successful, the interventions could raise screening uptake and lead to earlier detection of precancers, potentially reducing cervical cancer cases and deaths.
How similar studies have gone: Previous trials and meta-analyses have shown that mailed HPV self-sampling and offering self-sampling options can increase participation compared with standard invitation methods, though effectiveness can vary by setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 30 to 65 years old * Living in the study area (Departments of Marne and Aube, France) * At moderate risk of cervical cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter) Exclusion Criteria: * Outside the target age (less than 30 years old, or 66 years old and more) * Already participating in the current screening round * Total hysterectomy * History of cervical cancer * Current follow-up for abnormal cervical screening result or cervical lesions
Where it's running
-
Regional Cancer Screening Coordinating Centre, Aube site
Troyes, Aube, France Recruiting -
Regional Cancer Screening Coordinating Centre, Marne site
Reims, Marne, France Recruiting
Study contacts
- Principal investigator: Aurélie BERTRAND-BRICE, MD — Regional Cancer Screening Coordinating Centre, Marne site
- Study coordinator: Farida Selmouni, PhD
- Email: selmounif@iarc.who.int
- Phone: +33 4 72738485
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.