HPV Self-sampling in the General Population (MIRABELLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Other: Women receive invitation letter with HPV self-sampling kit; Other: Women receive invitation letter with choice of ordering a free self-sampling kit or visit healthcare provider

Detailed Description

In France, over 3,000 women are diagnosed annually with cervical cancer and 1,100 die from it, despite organized screening programs. The national screening coverage rate of 59% (2018- 2020) remains well below the European Union's recommended target of 70% and even further from the French Cancer Plan 2014-2019 objective of 80%. This study evaluates two innovative strategies to improve participation rates in two French departments (Marne and Aube). Eligible women aged 30-65 years will be randomized into three arms. The "Outreach" arm receives HPV self-sampling kit directly at home with SMS reminder at 3 months if no participation. The "Choice" arm can choose between ordering a self-sampling kit or visiting a healthcare provider with SMS reminder at 3 months if no participation. The control arm follows standard procedure with self-sampling offered at 12-month reminder. Women with positive HPV self-sampling tests will be followed for triage cytology, with assistance provided for appointments in the "Outreach" arm and reminders at 6 months post-positive result in the "Choice" arm. The study assesses participation rates, triage completion rates, feasibility, acceptability, and cost-effectiveness of these strategies. If successful, findings could inform modifications to the national organized screening program.

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Farida Selmouni, PhD; Phone Number: +33 4 72738485; Email: selmounif@iarc.who.int
• Study Contact Backup: Name: Catherine Sauvaget, MD, PhD; Phone Number: +33 4 72738485; Email: sauvagetc@iarc.who.int

Study Locations

• France
  • Aube
    • Troyes, Aube, France, 10000
      • Recruiting
      • Regional Cancer Screening Coordinating Centre, Aube site
      • Contact: Lucie FIEVET, MD; Phone Number: 03-26-84-93-31; Email: l.fievet@depistagecancer-ge.fr
  • Marne
    • Reims, Marne, France, 51100
      • Recruiting
      • Regional Cancer Screening Coordinating Centre, Marne site
      • Contact: Aurélie BERTRAND-BRICE, MD; Phone Number: 03-25-41-62-87; Email: a.bertrand@depistagecancer-ge.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participation rate in cervical cancer screening	18 months after invitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triage cytology completion rate after positive HPV test		6 months after positive result
HPV positivity rate		12 months after invitation
Invalid result rate		18 months
Time from HPV-positive result to completion of cytological triage		18 months
Women's acceptability of HPV self-sampling	Qualitative assessment through semi-structured interviews with 40 women to assess women's acceptability of HPV self-sampling	24 months
Cost-effectiveness of screening strategies	Costs will be estimated using an ingredients approach whereby resources used for the respective interventions (' Outreach ' and ' Choice' strategies) are identified and valued. The analysis will include all costs incurred by the screening program, including invitation materials, self-sampling kits, laboratory testing, result communication, and follow-up coordination. The incremental cost-effectiveness ratios (ICERs) will be calculated as the mean difference in total costs between each intervention arm and the control arm, divided by the mean difference in screening participation rates. Results will be expressed in euros per percentage change in screening participation.	24 months

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Collaborators: CHU de Reims; Central Hospital, Nancy, France; Centre Régional de Coordination des Dépistages des Cancers de Grand Est
• Investigators: Principal Investigator: Catherine SAUVAGET, MD, PhD, International Agency for Research on Cancer; Principal Investigator: Aurélie BERTRAND-BRICE, MD, Regional Cancer Screening Coordinating Centre, Marne site; Principal Investigator: Christine CLAVEL CRAVOISIER, Professor, Chu Reims; Principal Investigator: Hamza ACHIT, PhD, Chru Nancy; Principal Investigator: Farida SELMOUNI, PhD, International Agency for Research on Cancer

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: France; Cervical cancer; pilot project; randomised control trial; screening program
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: IEC/24-01; 2023-215 (Other Grant/Funding Number: INCa)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No