HPV Self-sampling in the General Population
NCT06749847 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000
Last updated 2025-07-23
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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