Actively Recruiting

Phase Not Applicable
Age: 26Years - 60Years
FEMALE
Healthy Volunteers
NCT06371118

HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme

Led by Universidade do Porto · Updated on 2024-05-14

1000

Participants Needed

2

Research Sites

28 weeks

Total Duration

On this page

Sponsors

U

Universidade do Porto

Lead Sponsor

U

Unidade de Saúde Familiar de Garcia de Orta, Porto

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening. An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post. Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway.

CONDITIONS

Official Title

HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme

Who Can Participate

Age: 26Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 26 and 60 years old
  • Women eligible for cervical cancer screening whose screening is at least 1 year overdue
Not Eligible

You will not qualify if you...

  • No mobile phone number available at the National Health Service database
  • Foreign mobile phone number
  • No address available at the National Health Service database
  • Foreign address

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Unidade de Saúde Familiar Cedofeita

Porto, Portugal, 4050-109

Actively Recruiting

2

Unidade de Saúde Familiar Prelada

Porto, Portugal, 4250-113

Actively Recruiting

Loading map...

Research Team

M

Maria Margarida MN Teixeira, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here