Clinical trial NCT03137563: Acceptability of HPV-self Sampling
Official title: Evaluation of the Acceptability of HPV Self-sampling Among French Women Eligible for Cervical Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Women
25-65 years
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Dépistages34 (Montpellier - France)
name: Adoc11 (Carcassonne - France)
name: Maison médicale Paul Valéry - Union Languedoc Mutualité - (Montpellier -France)
First posted: 2017-05-02
Enrollment: 356
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending 8 centers of the Departments of Hearault and Aude : social medical cares, Department of gynecology in the hospitals of Montpellier and Carcassonne ; mid-wifes consultations.

Brief summary: This trial aimed at evaluating the acceptability of HPV self-sampling among french women eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the south of France. Acceptability will be evaluated using an anonymous questionnaire and the main outcome of the study will be the response acceptability " yes " or " no " for HPV self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the acceptability of HPV self-sampling.

These data will help to propose new strategies for cervical cancer screening in France, particularly to taget non-attenting populations

Detailed description: Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the Region of Occitanie in the south of France).The questionnaire will be proposed to the women attending one of these eight centers by an investigator, who will verify the inclusion and exclusion criteria. The same person will collect the filled questionnaire.

The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability of HPV self-sampling and socio-economic determinants.

These questionnaires will be collected and statistical analysis will be performed using appropriate tools.

This study will bring informations on the acceptibility of HPV self sampling among french women eligible for cervical cancer screening in 2 Departements of the South of France. Self-sampling acceptability will be linked to socio-economic determinants.

These data will be important to propose and evaluate new strategies to improve screening coverage, particularly of the context of the organized cervical cancer screening that will take place in France in 2018.

Eligibility criteria: Inclusion Criteria:

* Women 25-65 years old
* Living in the Aude or Herault departments
* Informed patient Exclusion criteria
* Virgins
* Previous hysterectomy
* Present or previous cervical pathology
* Patient under guardianship or tutorship

Primary outcomes:
measure: accept HPV self-sampling for cervical cancer
timeFrame: 1 day
Secondary outcomes:
measure: Socioeconomic determinants of the response
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Nathalie BOULLE, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Bertucci M, Bonnet E, Satger L, Kreiche A, Chappert JL, Loy-Morel S, Segondy M, Daures JP, Boulle N. Acceptability of vaginal self-sampling with high-risk human papillomavirus testing for cervical cancer screening: a French questionnaire-based study. Women Health. 2021 Jan;61(1):83-94. doi: 10.1080/03630242.2020.1831683. Epub 2020 Oct 26.