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ACTIVE NOT RECRUITING
NCT05243888
NA

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

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15000

Start Date

2022-03-09

Completion Date

2025-03

Last Updated

2025-02-05

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

self-sampling

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

Locations (1)

CRCDC Pays de la Loire

Angers, France