Comparing Health Services Interventions for the Prevention of HPV-related Cancer

NCT ID: NCT02837926

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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women attending for cervical cancer screening

Group Type EXPERIMENTAL

questionnaire

Intervention Type OTHER

Gardasil vaccine

Intervention Type BIOLOGICAL

Cervarix®

Intervention Type BIOLOGICAL

Interventions

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questionnaire

Intervention Type OTHER

Gardasil vaccine

Intervention Type BIOLOGICAL

Cervarix®

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* women within the age range of 25-45
* attending cervical cancer screening

Exclusion Criteria

* previous history of HPV vaccine administration
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PO15019

Identifier Type: -

Identifier Source: org_study_id

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