Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

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.

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Key information

Conditions

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

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UH Tours

Tours, Indre Et Loire, 37000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

Participation / no participation to complete cervical cancer screening

Time frame: 9 months after postal mail
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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: APACHE-3

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 2, 2014
Registry last updated: Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed