Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

NCT ID: NCT02255084

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-09-30

Brief Summary

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.

Conditions

Cancer Cervix

Keywords

Cervical cancer screening; High Risk Human papillomavirus Infection; vaginal self-sampling; pap smear; general practitioner

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Group 1

Group 1 remove self sample kit at gp consulting room or perform pap smear :

Study coordinators send mail inviting women to remove a kit for vaginal self-sampling at their general practitioner s consulting room.

Either a pap smear is perform or, at home, women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).

Group Type: EXPERIMENTAL

Group 1 remove self sample kit at gp consulting room or perform pap smear

Intervention Type: BEHAVIORAL

Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.

Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Group 2

Group 2 perform self sample at home or pap smear :

Kit for vaginal self-sampling sent at women home. Women perform vaginal self sampling. Then women send it to a central laboratory for HPV test (Human papillomaVirus).

Group Type: EXPERIMENTAL

Group 2 perform self sample at home or pap smear

Intervention Type: BEHAVIORAL

Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.

When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Interventions

Group 1 remove self sample kit at gp consulting room or perform pap smear

Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.

Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Intervention Type: BEHAVIORAL

Group 2 perform self sample at home or pap smear

Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.

When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• women from 30 to 65 years old
• women living in french territorial division 37 ("Indre-et-Loire")
• women having a reported general practitioner in french territorial division 37 ("Indre-et-Loire")

Exclusion Criteria

• pap smear made in the three last years

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ken HAGUENOER, MD-PHD

Role: STUDY_DIRECTOR

Centre de coordination des dépistages des cancers, Tours, France

Somany SENGCHANH, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Centre de coordination des dépistages des cancers, Tours, France

Locations

UH Tours

Tours, Indre Et Loire, France

Countries

France

References

Boyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13.

Reference Type: RESULT

PMID: 35834620 (View on PubMed)

Other Identifiers

INCA13-KH / APACHE-3

Identifier Type: -

Identifier Source: org_study_id