RecruitingNot ApplicableNCT06749847

HPV Self-sampling in the General Population

HPV Self-sampling in the General Population: Efficacy, Feasibility, Acceptability and Cost-effectiveness


Sponsor

International Agency for Research on Cancer

Enrollment

6,000 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A randomized controlled trial comparing three strategies for cervical cancer screening: direct mailing of HPV self-sampling kit ("Outreach" arm), choice between self-sampling or healthcare provider sampling ("Choice" arm), and standard care (control arm) in two French departments.


Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

Interventions

OTHERWomen receive invitation letter with HPV self-sampling kit

Direct mailing of HPV self-sampling kit. Women receive HPV self-sampling kit with instructions. SMS reminder at 3 months if no participation. Assistance provided for triage cytology if HPV positive.

OTHERWomen receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

Option between self-sampling and healthcare provider: women can choose testing method. If self-sampling chosen, kit sent to home. SMS reminder at 3 months if no participation.


Locations(2)

Regional Cancer Screening Coordinating Centre, Aube site

Troyes, Aube, France

Regional Cancer Screening Coordinating Centre, Marne site

Reims, Marne, France

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NCT06749847


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