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

Phase 4

Completed

• Conditions: Cervical Cancer
• Interventions: Other: questionnaire; Biological: Gardasil vaccine; Biological: Cervarix®

• Registration Number: NCT02837926
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Primary Completion: 2017-12
• Study Completion: 2018-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

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

Exclusion Criteria

• previous history of HPV vaccine administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
women attending for cervical cancer screening	Cervarix®	-
women attending for cervical cancer screening	questionnaire	-
women attending for cervical cancer screening	Gardasil vaccine	-

Primary Outcome Measures

Name	Time	Method
number of vaccinated patients	up to 3 years

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France