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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
France
Regional Cancer Screening Coordinating Centre, Marne site
RECRUITING
Reims
Regional Cancer Screening Coordinating Centre, Aube site
RECRUITING
Troyes
Contact Information
Primary
Farida Selmouni, PhD
selmounif@iarc.who.int
+33 4 72738485
Backup
Catherine Sauvaget, MD, PhD
sauvagetc@iarc.who.int
+33 4 72738485
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 6000
Treatments
Experimental: Outreach
Women 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.
Experimental: Choice
Women receive an invitation letter offering a choice between ordering a free self-sampling kit or visiting a 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.
No_intervention: Control arm
Standard invitation to visit healthcare provider for cervical cancer screening. Standard screening procedure. Follow standard organized screening program procedure. HPV self-sampling offered at 12-month reminder if no participation.
Sponsors
Collaborators: CHU de Reims, Central Hospital, Nancy, France, Centre Régional de Coordination des Dépistages des Cancers de Grand Est
Leads: International Agency for Research on Cancer

This content was sourced from clinicaltrials.gov