Offering self-sampling devices to increase cervical cancer screening in Belgian GP practices
Randomized Participation Trials: Increase in Response by Offering Self-sampling Devices in Belgian GP Practices to Non-screened Women
This study is testing whether giving women self-sampling devices for cervical cancer screening through their doctors can help more of them get screened after not having done so for over three years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 30 Years to 64 Years |
| Sex | Female |
| Sponsor | Sciensano Government |
| Locations | 3 sites (Brussels and 2 other locations) |
| Trial ID | NCT04903561 on ClinicalTrials.gov |
What this trial studies
This research aims to enhance cervical cancer screening participation among women who have not been screened in over three years by providing self-sampling devices directly through general practitioners (GPs). The study will replicate earlier findings that showed a significant increase in screening response rates when women were offered self-sampling kits during GP visits. It will also assess GPs' knowledge of cervical cancer risk factors as documented in patient files. The study will utilize clinically validated high-risk HPV tests on self-samples to improve screening accuracy and accessibility.
Who should consider this trial
Good fit: Ideal candidates for this study are women who have not been screened for cervical cancer in the last three years and are visiting their GP for any reason.
Not a fit: Patients who are pregnant, under active follow-up for previous cervical abnormalities, have had a total hysterectomy, or have a history of cervical cancer or recent treatment for cervical precancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase cervical cancer screening rates among under-screened women, leading to earlier detection and better outcomes.
How similar studies have performed: Previous studies have indicated success in increasing screening rates through similar self-sampling approaches, suggesting that this method is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women who have not been screened for cervical cancer since the last three years * visiting their GP for whatever reason Exclusion Criteria: * pregnant women, * women under active follow-up because of previous cervical abnormality, * women who had a total hysterectomy, * women who had a history of cervical cancer or a treatment for cervical precancer less than three years ago, * non-consenting women, * women who are not able to understand and sign the informed consent
Where this trial is running
Brussels and 2 other locations
- Université catholique de Louvain — Brussels, Belgium (Recruiting)
- Université de Liège — Liège, Belgium (Completed)
- Maison médicale Neptune — Schaarbeek, Belgium (Recruiting)
Study contacts
- Study coordinator: Marc Arbyn, MD
- Email: marc.arbyn@sciensano.be
- Phone: +32 2 642 50 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.