Back to resultsComparing Health Services Interventions for the Prevention of HPV-related Cancer (CoheaHr-WP4)
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
questionnaire
Gardasil vaccine
Cervarix®
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- women within the age range of 25-45
- attending cervical cancer screening
Exclusion Criteria:
- previous history of HPV vaccine administration
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
women attending for cervical cancer screening
Arm Description
Outcomes
Primary Outcome Measures
number of vaccinated patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02837926
Brief Title
Comparing Health Services Interventions for the Prevention of HPV-related Cancer
Acronym
CoheaHr-WP4
Official Title
Work Package 4: HPV Vaccination of Women in Screening Ages
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.
Detailed Description
3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.
Safety data and HPV vaccine compliance will be assessed.
A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.
Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
women attending for cervical cancer screening
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Type
Biological
Intervention Name(s)
Gardasil vaccine
Intervention Type
Biological
Intervention Name(s)
Cervarix®
Primary Outcome Measure Information:
Title
number of vaccinated patients
Time Frame
up to 3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women within the age range of 25-45
attending cervical cancer screening
Exclusion Criteria:
previous history of HPV vaccine administration
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparing Health Services Interventions for the Prevention of HPV-related Cancer
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