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

NCT05243888 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15000

Last updated 2025-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Cancer Screening Test

Interventions

DIAGNOSTIC_TEST

self-sampling

eligible women receive at their home address a self-sampling kit in addition to the conventional invitation letter

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Sciensano

    collaborator OTHER_GOV

  • University Hospital, Angers

    collaborator OTHER_GOV

  • University of Angers

    collaborator UNKNOWN

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-08-31
Completion
2025-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243888 on ClinicalTrials.gov