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Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women

NCT04903561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2023-11-24

No results posted yet for this study

Summary

Small scale data indicate that cervical cancer screening participation may increase when self-sampling (SS) devices are offered directly by health care workers to non-screened woman, when those woman contact health services for whatever reason. The purpose of the current research is to reproduce the early findings of a MSc project conducted in a general practitioners (GP) group practice in Brussels, where women not screened since \>3 years randomized to direct reception of a SS kit yielded a response of 78% vs 51% in the control arm.

BELGSSAR will also investigate whether GP's have the information on the most important risk factors for cervical cancer available in their patient files.

Conditions

Interventions

DEVICE

ColliPee

The GP will hand over the self-sampling kit to the women, after obtaining informed consent, and the women then takes the self sample at home or in the doctor's office (predefined), according to the respective users manual.

Sponsors & Collaborators

  • Horizon 2020 - European Commission

    collaborator OTHER

  • Sciensano

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT04903561 on ClinicalTrials.gov