Acceptability of HPV-self Sampling

December 29, 2020 updated by: University Hospital, Montpellier

Evaluation of the Acceptability of HPV Self-sampling Among French Women Eligible for Cervical Cancer Screening

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

356

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women eligible for cervical cancer screening
French women aged 25 to 65 years living in the Department of Hérault or Aude (France), attending one of the 8 centers where the questionnaire will be distributed
Other: questionnaire
The questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria.
Other Names:
  • Distribution of an anonymous questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accept HPV self-sampling for cervical cancer
Time Frame: 1 day
Response " Yes " or " No " to the question " would you accept HPV self-sampling for cervical cancer screening ?
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socioeconomic determinants of the response
Time Frame: 1 day
Socioeconomic determinants of the response " yes " or " no " to the question " would you accept HPV self-sampling for cervical cancer screening ?
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Dépistages34 (Montpellier - France)
Adoc11 (Carcassonne - France)
Maison médicale Paul Valéry - Union Languedoc Mutualité - (Montpellier -France)

Investigators

  • Study Director: Nathalie BOULLE, MD, PhD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF9839

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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