New Methods of Distribution of a Self Sampler Kit for Cervical Cancer Screening
NMDSS2
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.
1 other identifier
observational
15,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 24, 2012
May 1, 2012
3 months
July 17, 2012
July 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
performing a HPV test within 3 months since the recall letter
up to december 2012 (up to 3 months)
Secondary Outcomes (1)
How many of the women performing a test after intervention were never-screened or under-screened (last test more than 3 years before)
up to december 2012 (up to 3 months)
Study Arms (3)
control 1
standard recall letter to perform HPV test at the clinic
Intervention 1
direct mailing of the self sampling device at home
intervention 2
invitation to retire the self sampling device in local pharmacy
Eligibility Criteria
Involving 15000 women non-responders to previous calls in five different screening programs in Italy (Rome, Bologna, Abruzzo region, Molise region, Veneto region).
You may qualify if:
- All women (aged 35-64 years) non-responding to the screening invitation in the previous year and eligible for recall
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AUSL4 Teramo
Teramo, TE, 64100, Italy
Related Publications (1)
Giorgi 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: 25633037DERIVED
Biospecimen
vaginal washings
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emma Altobelli, Prof.
AUSL4 Teramo - Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Responsable U.O. Epidemiology and Social Marketing
Study Record Dates
First Submitted
July 17, 2012
First Posted
July 24, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
July 24, 2012
Record last verified: 2012-05