Home-delivered HPV self-sampling for women overdue for cervical cancer screening
HPV Self-sampling for Women Who do Not Attend the Organized Cervical Cancer Screening Programme (HERSELF)
This study is testing whether sending home HPV self-sampling kits to women aged 26 to 60 who have missed their cervical cancer screenings can help them get screened more often compared to regular screening invitations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 26 Years to 60 Years |
| Sex | Female |
| Sponsor | Universidade do Porto Academic / other |
| Locations | 2 sites (Porto and 1 other locations) |
| Trial ID | NCT06371118 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and cost-effectiveness of two home-delivered HPV self-sampling strategies compared to standard cervical cancer screening invitations. Women aged 26 to 60 who are overdue for screening will be randomized into a control group receiving standard care or an intervention group receiving either a directly mailed self-sampling kit or an opt-in invitation for the kit. The study aims to determine which approach increases adherence to screening and assess the associated costs. The research will take place at three primary healthcare centers in the Western Porto region.
Who should consider this trial
Good fit: Ideal candidates are women aged 26 to 60 who are overdue for cervical cancer screening by at least one year.
Not a fit: Patients who do not have a registered mobile phone number or address in the National Health Service database will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase cervical cancer screening rates among women who are currently overdue, leading to earlier detection and better outcomes.
How similar studies have performed: Previous studies have shown that home-delivered self-sampling can improve screening adherence, making this approach promising but still requiring further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged between 26 and 60 years old; * Women eligible for cervical cancer screening whose screening is at least 1 year overdue. Exclusion Criteria: * No mobile phone number available at the National Health Service database; * Foreign mobile phone number; * No address available at the National Health Service database; * Foreign address.
Where this trial is running
Porto and 1 other locations
- Unidade de Saúde Familiar Cedofeita — Porto, Portugal (Recruiting)
- Unidade de Saúde Familiar Prelada — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Maria Margarida MN Teixeira, MD — Instituto de Saude Publica da Universidade do Porto
- Study coordinator: Maria Margarida MN Teixeira, Master
- Email: margaridat93@gmail.com
- Phone: 00351933099685
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.