Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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