HPV Self-sampling in the General Population

NCT06749847 | Recruiting

• 2 other identifiers: IEC/24-012023-215
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 2

Brief 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

Cervical Cancer

Keywords

Cervical cancer; screening program; pilot project; randomised control trial; France

Outcome Measures

Primary Outcomes (1)

• Participation rate in cervical cancer screening

  18 months after invitation

Secondary Outcomes (6)

• 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

  24 months

Study Arms (3)

Outreach

EXPERIMENTAL

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

Choice

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

Women receive invitation letter with HPV self-sampling kit OTHER

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.

Outreach

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

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.

Choice

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Centre Régional de Coordination des Dépistages des Cancers de Grand Est: collaborator
• Central Hospital, Nancy, France: collaborator
• CHU de Reims: collaborator

Study Sites (2)

Regional Cancer Screening Coordinating Centre, Aube site

Troyes, Aube, 10000, France

RECRUITING

Regional Cancer Screening Coordinating Centre, Marne site

Reims, Marne, 51100, France

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Catherine SAUVAGET, MD, PhD

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farida Selmouni, PhD

CONTACT

+33 4 72738485; selmounif@iarc.who.int

Catherine Sauvaget, MD, PhD

CONTACT

+33 4 72738485; sauvagetc@iarc.who.int

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a three-arm study

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 27, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)