HPV Self-sampling in the General Population

NCT06749847 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

Women 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.

Sponsors & Collaborators

  • Centre Régional de Coordination des Dépistages des Cancers de Grand Est

    collaborator UNKNOWN
  • Central Hospital, Nancy, France

    collaborator OTHER
  • CHU de Reims

    collaborator OTHER
  • International Agency for Research on Cancer

    lead OTHER

Principal Investigators

  • Aurélie BERTRAND-BRICE, MD · Regional Cancer Screening Coordinating Centre, Marne site

  • Christine CLAVEL CRAVOISIER, Professor · CHU REIMS

  • Hamza ACHIT, PhD · CHRU Nancy

  • Farida SELMOUNI, PhD · International Agency for Research on Cancer

  • Catherine SAUVAGET, MD, PhD · International Agency for Research on Cancer

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-26
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06749847 on ClinicalTrials.gov