HPV Self-sampling for Women Who do Not Attend the Organized Cervical Cancer Screening Programme (HERSELF)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 26
Maximum Age: 60
Healthy Volunteers: t
View:

• Women aged between 26 and 60 years old;

• Women eligible for cervical cancer screening whose screening is at least 1 year overdue.

Locations
Other Locations
Portugal
Unidade de Saúde Familiar Cedofeita
RECRUITING
Porto
Unidade de Saúde Familiar Prelada
RECRUITING
Porto
Contact Information
Primary
Maria Margarida MN Teixeira, Master
margaridat93@gmail.com
00351933099685
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2024-11
Participants
Target number of participants: 1000
Treatments
Active_comparator: Control group
An invitation to attend a cervical cancer screening in a clinical setting will be sent by post to the woman's address.
Experimental: Intervention 1 (directly mailed group)
The HPV self-sampling test will be sent by post directly to the woman's address.
Experimental: Intervention 2 (opt-in group)
The HPV self-sampling test will be sent by post directly to the woman's address after a opt-in procedure.
Sponsors
Collaborators: Unidade de Saúde Familiar de Cedofeita, Porto, Unidade de Saúde Familiar de Garcia de Orta, Porto, Unidade de Saúde Familiar da Prelada, Porto, Instituto Portugues de Oncologia, Francisco Gentil, Porto
Leads: Universidade do Porto

This content was sourced from clinicaltrials.gov