Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening (CapU4)

February 3, 2025 updated by: Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire

A Randomised Controlled Trial Assessing the Efficacy of Strategies Involving Self-sampling to Reach Women Not Participating in Regular Cervical Cancer Screening

The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France.

The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than four years and who did not respond to an invitation letter within twelve months before. The primary outcome measure is the participation rate in each arm.

A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.

CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Research question: does the offer of self-sampling kits result in higher attendance to cervical cancer screening compared to sending invitation letters which recommend women to contact a health professional for taking a cervical specimen?

Systematic reviews indicate that Human Papillomavirus (HPV) testing on vaginal specimens taken by the woman her-self is as accurate to detect cervical precancer as HPV testing of cervical specimens collected by a clinician, under the condition that a validated polymerase chain reaction (PCR)-based HPV assay is used. Similar results are shown from recent studies where HPV testing was performed on first-void urine collected with an appropriate device and transport medium. A recent meta-analysis of randomised trials showed higher response rates when under-screened women receive a self-sampling kit at home compared to traditional invitation or reminder letters. However, the absolute participation rates are highly variable among studies. Whereas qualitative research indicates that women prefer collection of urine rather than a vaginal self-sample, no data are available that the offer of urine kits would result in higher participation among women who do not participate regularly in cervical cancer screening.

Objectives:

  • To evaluate the effectiveness of two experimental invitation strategies (urine or vaginal self-sampling) to reach under-screened populations and compare them to the current invitation strategy in rural departments in France.
  • To improve the response rate among women aged 30 to 65 years (not screened over a period longer than the recommended screening interval) who did not respond to a conventional prior invitation.

Trial design:

1:1:1 randomised population-based participation trial, with 2 experimental and 1 control arm, with in each arm a 1:1 sub-randomisation with subgroup A receiving a questionnaire and subgroup B receiving no questionnaire.

Study Type

Interventional

Enrollment (Estimated)

15000

Phase

  • Not Applicable

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
      • Angers, France
        • CRCDC Pays de la Loire

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • women aged between 30 and 65 years
  • living in the Departments of Mayenne, Vendée and Sarthe (Pays de la Loire, France)
  • who have not carried out a screening test (cytology of smear or HPV test) following a letter sent 12 months previously (in 2020 or 2021).

Exclusion Criteria:

  • recent cervical sampling (less than three years old)
  • women younger than 30 or older than 65 years
  • women who have had a hysterectomy
  • women with ongoing follow-up for a cervical lesion
  • women who are not members or beneficiaries of a social security system.

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
The control arm corresponds to women receive a conventional invitation letter sent by post to the home address of eligible women recommending them to make an appointment to a doctor or a midwife for the collection of a cervical specimen.
Experimental: vaginal self-sampling
eligible women receive at their home address a vaginal self-sampling kit in addition to the conventional invitation letter
Diagnostic test: self-sampling
eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter
Experimental: urinary self-sampling
eligible women receive at their home address a urine collection kit in addition to the conventional invitation letter
Diagnostic test: self-sampling
eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participation in each arm (%)
Time Frame: 6 months
(number of responding / number of invited)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participation (%)
Time Frame: 6 months
(number of responding / number of invited). Contrast in participation between the 2 experimental arms
6 months
Rate of participation (%) with questionnaire or not
Time Frame: 6 months
(number of responding / number of invited). Contrast in participation between women that received a questionnaire or not
6 months
Rate of screen test positivity (%)
Time Frame: 24 months
Virological result. presence of high-risk HPV
24 months
Percentage of women screened positive with adherence to gynecological follow-up
Time Frame: 24 months
gynecological follow-up (cytological results)
24 months
Impact of age on the participation (rate of participation %)
Time Frame: 6 months
age
6 months
Impact of age on the adherence to gynecological follow-up (% of women)
Time Frame: 24 months
age
24 months
Impact of reimbursement status on the participation (rate of participation %)
Time Frame: 6 months
reimbursement status (benefit or not from supplementary universal health care coverage)
6 months
Impact of reimbursement status on the adherence to gynecological follow-up (% of women)
Time Frame: 24 months
reimbursement status (benefit or not from supplementary universal health care coverage)
24 months
Impact of geographical area on the participation (rate of participation %)
Time Frame: 6 months
geographical area (including the deprivation index corresponding with the statistical sector where the woman is domiciled)
6 months
Impact of geographical area on the adherence to gynecological follow-up (% of women)
Time Frame: 24 months
geographical area (geographical area (including the deprivation index corresponding with the statistical sector where the woman is domiciled)
24 months
Obstacles and levers emerging from the speech of the women participating in the research (thematic analysis)
Time Frame: 24 months
thematic analysis integrating a specific focus on the indicators identified in previous studies (e.g. lack of time, discomfort with regard to the location or bad experience encountered during another type of examination, etc.).
24 months
Obstacles and levers emerging from the speech of the women participating in the research (categorical analysis)
Time Frame: 24 months
categorical analysis based on Linguistic Inquiry and Word count which allows, among other things, to automatically categorise positive or negative emotions related to themes for example associated with the disease or beliefs
24 months
Obstacles and levers emerging from the speech of the health professionals participating in the research (thematic analysis)
Time Frame: 24 months
thematic analysis integrating a specific focus on the indicators identified in previous studies (e.g. lack of time, discomfort with regard to the location or bad experience encountered during another type of examination, etc.).
24 months
Obstacles and levers emerging from the speech of the health professionals participating in the research (categorical analysis)
Time Frame: 24 months
categorical analysis based on Linguistic Inquiry and Word count which allows, among other things, to automatically categorise positive or negative emotions related to themes for example associated with the disease or beliefs
24 months

Collaborators and Investigators

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

Sponsor

Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire

Collaborators

University Hospital, Angers
National Cancer Institute, France
Sciensano
University of Angers

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)

March 9, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01660-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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