Clinical trial · Interventional
HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme
HPV Self-sampling for Women Who do Not Attend the Organized Cervical Cancer Screening Programme (HERSELF)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening. An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post. Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Early Detection of Cancer | — | UNRESOLVED | — |
| Papillomavirus Infections | — | UNRESOLVED | — |
| Self-Examination | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Directly mailed self-sampling kit to collect a vaginal sample | Device | — | UNRESOLVED |
| Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure | Device | — | UNRESOLVED |
| Standard of care - screening in a clinical setting | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- An invitation to attend a cervical cancer screening in a clinical setting will be sent by post to the woman's address.
- interventionNames
- Diagnostic Test: Standard of care - screening in a clinical setting
- type
- EXPERIMENTAL
- label
- Intervention 1 (directly mailed group)
- description
- The HPV self-sampling test will be sent by post directly to the woman's address.
- interventionNames
- Device: Directly mailed self-sampling kit to collect a vaginal sample
- type
- EXPERIMENTAL
- label
- Intervention 2 (opt-in group)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available