Clinical trial · Observational
New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening
Experimentation of New Organizational Models of Cervical Cancer Screening Programs, Upon the Use of HPV Test as First Level: Evaluation of the Methodologies Proposed of the Use of Self-sampling Devices to Recover Non-responders.
- 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)
The opportunity of a home, self-collected sample, opens the chance to remove some of the barriers that may discourage women from participating to screening programmes or performing HPV (Human Papilloma Virus)-test. Self-sampling is less time consuming and invasive as compared with tests performed at a clinic. It allows for privacy, reduces discomfort and women know nobody would have to handle their body. Study hypothesis: The use of a self-sampler may increase the recovery of non-responders women at cervical cancer screening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Cin Grade | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- control 1
- description
- standard recall letter to perform HPV test at the clinic
- label
- Intervention 1
- description
- direct mailing of the self sampling device at home
- label
- intervention 2
- description
- invitation to retire the self sampling device in local pharmacy
Primary outcomes (1)
- measure
- performing a HPV test within 3 months since the recall letter
- timeFrame
- up to december 2012 (up to 3 months)
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall Exclusion Criteria: does not meet inclusion criteria
References
Publications (1)
- DERIVEDGiorgi Rossi P, Fortunato C, Barbarino P, Boveri S, Caroli S, Del Mistro A, Ferro A, Giammaria C, Manfredi M, Moretto T, Pasquini A, Sideri M, Tufi MC, Cogo C, Altobelli E; HPV Self-sampling Italian Working Group. Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter. Br J Cancer. 2015 Feb 17;112(4):667-75. doi: 10.1038/bjc.2015.11. Epub 2015 Jan 29. PMID 25633037