Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner
Participation in Screening for Cervical Cancer: Interest of a Self-sampling Device Provided by the General Practitioner
This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to
 the French opportunistic cervical cancer screening program, of an organized screening with
 the proposition by the family physician of a pap-test (usual care) versus a self-collected
 vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized
 in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that
 organizing the screening for these women involving their family physician will major
 participation, and that the self-sampling option will amplify this increase.
In France screening for cervical cancer (CC) is usually based on an opportunistic screening
 program. French guidance recommends performing a smear every 3 years from the age of 25 to 65
 years, after 2 initial normal yearly smears. Pap-tests can be carried out by medical doctors
 or midwifes. The coverage rate is estimated between 56.6% and 83.0%. In deprived populations,
 about 55% of women are unscreened as their risk to develop a CC is majored. The gynecologic
 examination and the consultation of a gynecologist appear to be the main barriers to the
 pap-test. Almost all these unscreened women visit their family physician at least yearly for
 themselves or with a relative, but many family physicians do not perform pap-tests. Our
 hypothesis is that more women are to be screened if they are invited to by their family
 physician (who carries out the pap-test himself or who refers the woman to a gynecologist or
 a midwife), and that the screening rate will be majored if the family physician delivers to
 his female patients, who are not willing to undergo a pap-smear, a vaginal self-sampling
 device.

 To demonstrate this, we will conduct an open label 1:1 cluster randomized controlled trial.
 As the gender of the physician and his ability to carry out pap-tests is associated to the
 rate of his listed screened female patients, randomization will be stratified on these two
 variables. The 24 participating physicians (12 in each study arm) will enroll 2000 unscreened
 female patients. The study population will be all the social security insured unscreened
 listed women aged from 30 to 65 years of the participating physicians. As the specificity of
 the HPV-test to screen for CC is insufficient before the age of 30, woman between 25 and 29
 years of age will not be part of the study.

 All these women (unless an exclusion criterion appears in their medical record) will receive
 from their family physician an invitation letter to make an appointment for an encounter
 dedicated to CC screening. Women who accept to be enrolled in the study will sign a consent
 form and will be invited to fill in a questionnaire about their socio-economic profile and
 their beliefs and attitudes about prevention, cancer screening in general and screening for
 CC in particular. Participation to the screening process is not necessary for inclusion.
 Women in the control arm will be solely proposed to undergo a pap-test performed by their
 family physician or a gynecologist or a midwife. Women in the intervention arm will be
 alternatively proposed to proceed to an at home performed vaginal self-collection of a sample
 that is to be send by post to a centralized lab for HPV testing. HPV tests will be conducted
 by the virology lab of the University Hospital of Lille.

 All screened negative women in both arms of the study will be considered as successful
 outcomes and finish the study. HPV screened positive women from the self-collection arm will
 be proposed a triage pap-test or colposcopy. Further 18 months follow-up will be matching
 French guidelines.
Inclusion Criteria:

 -  To be a woman

 -  Aged from 30 to 65 years (30 and 65 years included)

 -  Without reimbursement of a pap-test by the health insurance for more than 3 years,
 despite a reminder mailed by the health insurance on the previous year (list set up by
 the health insurance).

 -  Able to understand and sign voluntarily the consent to participate

 -  Warranted by the health insurance

 -  Able to understand and answer the questions of the study questionnaire alone or with
 the help of a self-chosen third party.

 Exclusion Criteria:

 -  No vaginal intercourse ever

 -  Pap-test quoted on another budget (hospital, mother and child protection…) conducted
 less than 3 years ago

 -  Known cervical lesion or known HPV status

 -  History of hysterectomy

 -  History of conisation

 -  History of laser treatment of the cervix

 -  History of cervical cancer

 -  Other medical reason to delay cervical cancer screening

 -  Abroad for more than one year

 -  Moving to another region (done or expected)

 -  Pregnant or breastfeeding

 -  Screening not relevant from the practitioner's perspective (Emergency situation,
 comorbidity…)