Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

NCT02255084 | Completed

• 1 other identifier: INCA13-KH / APACHE-3
• Study Type: interventional
• Target: 3,612
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Participation / no participation to complete cervical cancer screening

  Uncompleted cervical cancer screening is defined as one of the followings : * no pap smear * no vaginal self-sampling * noninterpretable HPV test result and no pap smear * positive HPV test result and no control pap smear

  9 months after postal mail

Study Arms (2)

Group 1

EXPERIMENTAL

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).

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

Group 2

EXPERIMENTAL

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).

Behavioral: Group 2 perform self sample at home or pap smear

Interventions

Group 2 perform self sample at home or pap smear 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.

Group 2

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

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• pap smear made in the three last years

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

UH Tours

Tours, Indre Et Loire, 37000, France

Location

Related Publications (1)

• 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.

  PMID: 35834620 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papanicolaou Test

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ken HAGUENOER, MD-PHD

  Centre de coordination des dépistages des cancers, Tours, France

  STUDY DIRECTOR

• Somany SENGCHANH, MD-PHD

  Centre de coordination des dépistages des cancers, Tours, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 2, 2014
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)