Vaginal Self-sampling and Human Papillomavirus Testing in Unscreened Women

University Hospital, Tours3,612 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

3,612

Conditions

Cancer Cervix

Interventions

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 smearBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 9 months after postal mail