Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women (APACHE-3)

Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner

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.

Study Overview

• Status: Completed
• Conditions: Cancer Cervix
• Intervention / Treatment: Behavioral: Group 1 remove self sample kit at gp consulting room or perform pap smear; Behavioral: Group 2 perform self sample at home or pap smear

• Study Type: Interventional
• Enrollment (Actual): 3612
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Indre Et Loire
    • Tours, Indre Et Loire, France, 37000
      • UH Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Ken HAGUENOER, MD-PHD, Centre de coordination des dépistages des cancers, Tours, France; Principal Investigator: Somany SENGCHANH, MD-PHD, Centre de coordination des dépistages des cancers, Tours, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: October 1, 2014
• First Posted (Estimated): October 2, 2014

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cervical cancer screening; pap smear; general practitioner; vaginal self-sampling; High Risk Human papillomavirus Infection
• 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; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Biopsy; Cytodiagnosis; Papanicolaou Test
• Other Study ID Numbers: INCA13-KH / APACHE-3