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Trial Title:
HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme
NCT ID:
NCT06371118
Condition:
Papillomavirus Infections
Early Detection of Cancer
Cervix Cancer
Self-Examination
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Directly mailed self-sampling kit to collect a vaginal sample
Description:
The HPV self-sampling test will be sent by post directly to the woman's address. If the
woman does not return the sample within 20 days, she will be sent a SMS reminder.
The returned samples will be analysed. If high-risk HPV is present, women will be invited
to be screened for cervical cancer in a clinical setting by their family doctors.
Self-samples in which high-risk HPV is present will also be subjected to HPV DNA
methylation test. If an abnormal HPV DNA methylation is detected and the woman has not
attended the screening in a clinical setting yet, she will be informed by her family
doctor that a new test has indicated the need to attend a medical appointment.
Arm group label:
Intervention 1 (directly mailed group)
Other name:
Evalyn Brush
Intervention type:
Device
Intervention name:
Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure
Description:
Women will initially receive an invitation letter in their home addresses to receive the
self-sampling kit, as well as a pre-paid envelope to return the answer to this
invitation. If the woman does not return the answer within 10 days, she will be sent a
SMS reminder. Only those who respond affirmatively to the question will receive the
self-sampling kit.
The steps that follow will be the same as in intervention 1.
Arm group label:
Intervention 2 (opt-in group)
Other name:
Evalyn Brush
Intervention type:
Diagnostic Test
Intervention name:
Standard of care - screening in a clinical setting
Description:
Corresponds to the standard of care. An invitation to attend the conventional cervical
cancer screening (clinician-collected cervical sample for HPV test and reflex cytology)
will be sent by post to the woman's address.
Arm group label:
Control group
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.
Detailed description:
The goal of this randomized clinical trial is to test the effectiveness and
cost-effectiveness of two different strategies of home-delivered HPV self-sampling to
increase the adherence to cervical cancer screening in women who are overdue for cervical
cancer screening, in comparison to the standard of care strategy.
The main questions this study aims to answer are:
- To test the effectiveness of an invitation strategy to improve the adherence to
cervical cancer screening based on directly home-delivered HPV self-sampling tests +
automated reminders, in comparison to the standard of care invitation.
- To test the effectiveness of an invitation strategy to improve the adherence to
cervical cancer screening based on home-delivered HPV self-sampling tests using
opt-in procedures for ordering the kit + automated reminders, in comparison to the
standard of care invitation.
- To compare the cost-effectiveness between a) standard of care; b) directly
home-delivered HPV self-sampling tests + automated reminders; and c) home-delivered
HPV self-sampling tests using opt-in procedures for ordering the kit + automated
reminders.
Eligible women will be randomized (1:1) into a control group and an intervention group:
- Control group: corresponds to the standard of care, which is an invitation to
cervical cancer screening in a clinical setting, through a written letter, printed
and sent by the primary healthcare unit where the women are registered.
- Intervention group: Women allocated to this group will be randomized (1:1) into two
subgroups, described briefly as follows:
- Intervention 1 (half of the intervention group): HPV self-sampling test mailed
directly to the women's home address (directly mailed group), complemented with
a SMS reminder. If a woman returns the sample, HPV-type genotyping will be
performed. If High-Risk HPV (HR-HPV) is detected, women will be informed of the
result and invited to take cervical cancer screening in a clinical setting by
their family doctors. Subsequent follow-up will take place according to
Portuguese guidelines.
- Intervention 2 (half of the intervention group): An invitation is mailed to the
women´s home address, offering a self-sampling kit, to be ordered by returning
a prepaid envelope with the answer "yes" (opt-in group). In the event of a
positive response, an HPV self-sampling test is mailed to the women's home,
complemented with a SMS reminder. If a woman returns the sample, HPV genotyping
will be performed. If HR-HPV is detected, women will be informed of the result
and invited to take cervical cancer screening in a clinical setting, performed
by their family doctors. Subsequent follow-up will take place according to
Portuguese guidelines.
In Interventions 1 and 2, when HR-HPV is detected in the self-sampling test, this sample
will be subjected to HPV-DNA methylation testing. If increased HPV DNA methylation is
detected and the woman has yet not attended the conventional screening invitation by her
family doctor, she will be informed by her family doctor that a new test has indicated an
increased risk for cervical cancer and the need to attend a medical appointment will be
reinforced.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged between 26 and 60 years old;
- Women eligible for cervical cancer screening whose screening is at least 1 year
overdue.
Exclusion Criteria:
- 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.
Gender:
Female
Gender based:
Yes
Gender description:
Women
Minimum age:
26 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Unidade de Saúde Familiar Cedofeita
Address:
City:
Porto
Zip:
4050-109
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Teixeira
Phone:
00351933099685
Facility:
Name:
Unidade de Saúde Familiar Prelada
Address:
City:
Porto
Zip:
4250-113
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Teixeira
Phone:
00351933099685
Start date:
April 15, 2024
Completion date:
November 2024
Lead sponsor:
Agency:
Universidade do Porto
Agency class:
Other
Collaborator:
Agency:
Unidade de Saúde Familiar de Garcia de Orta, Porto
Agency class:
Other
Collaborator:
Agency:
Unidade de Saúde Familiar da Prelada, Porto
Agency class:
Other
Collaborator:
Agency:
Unidade de Saúde Familiar de Cedofeita, Porto
Agency class:
Other
Collaborator:
Agency:
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Agency class:
Other
Source:
Universidade do Porto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06371118
