Skip to main content
OpenTrials
Completed

NCT Number: NCT02837926

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous history of HPV vaccine administration

Treatment and study plan

Questionnaire

Other

Gardasil vaccine

Biological

Cervarix®

Biological

Primary outcomes

  1. number of vaccinated patients

    Time frame: up to 3 years

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Work Package 4: HPV Vaccination of Women in Screening Ages

Acronym: CoheaHr-WP4

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.