Papillomavirus InfectionsHERSELFNCT06371118
HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme
A study testing Directly mailed self-sampling kit to collect a vaginal sample and Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure in people with Papillomavirus Infections and Early Detection of Cancer, run by Universidade do Porto at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections, Early Detection of Cancer, Cervix Cancer
- What is being tested?
- Directly mailed self-sampling kit to collect a vaginal sample and Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesPortugal
- Study dates
- 15 Apr 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 26 and 60 years old;
- Women eligible for cervical cancer screening whose screening is at least 1 year overdue.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Recruiting
Unidade de Saúde Familiar Cedofeita
Porto, 4050-109
Teixeira, 00351933099685
- Recruiting
Unidade de Saúde Familiar Prelada
Porto, 4250-113
Teixeira, 00351933099685
About this study
Official title: HPV Self-sampling for Women Who do Not Attend the Organized Cervical Cancer Screening Programme (HERSELF)
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.
Read the 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.
- Being tested
- Directly mailed self-sampling kit to collect a vaginal sample, Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure, Standard of care - screening in a clinical setting
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directly mailed self-sampling kit to collect a vaginal sampleDevice
Also called Evalyn Brush
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.
Mailed self-sampling kit to collect a vaginal sample after opt-in prodecureDevice
Also called Evalyn Brush
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.
Standard of care - screening in a clinical settingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | An invitation to attend a cervical cancer screening in a clinical setting will be sent by post to the woman's address. Receives: Diagnostic Test: Standard of care - screening in a clinical setting |
| Intervention 1 (directly mailed group) | Experimental | The HPV self-sampling test will be sent by post directly to the woman's address. Receives: Device: Directly mailed self-sampling kit to collect a vaginal sample |
| Intervention 2 (opt-in group) | Experimental | The HPV self-sampling test will be sent by post directly to the woman's address after a opt-in procedure. Receives: Device: Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to conventional screening in control group
Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group
Measured: 45 and 90 days after the conventional screening appointment date
Adherence to HPV self-sampling in intervention 1 (directly mailed) group
Number of women who returned the self-sample in intervention 1 group divided by the number of women assigned to intervention 1 group
Measured: 45 and 90 days after the day the self-sampling kit is sent
Adherence to HPV self-sampling in intervention 2 (opt-in) group
Number of women who returned the self-sample in intervention 2 group divided by the number of women assigned to intervention 2 group
Measured: 45 and 90 days after the day the self-sampling kit is sent
Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group
The quotient of (Number of women in intervention 1 group who returned the self-sample divided by the women assigned to intervention 1 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).
Measured: 45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate
Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group
The quotient of (Number of women in intervention 2 group who returned the self-sample divided by the women assigned to intervention 2 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).
Measured: 45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate
Secondary outcomes (51)
Adherence to first follow-up step in control group
Quotient of the number of women in control group who adhered to first follow-up step (in this case, colposcopy) divided by the number of women assigned to control group
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to first follow-up step in intervention 1 (directly mailed) group
Quotient of the number of women in intervention 1 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 1 group
Measured: 45 and 90 days after the clinician-sampling appointment date
Adherence to first follow-up step in intervention 2 (opt-in) group
Quotient of the number of women in intervention 2 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 2 group
Measured: 45 and 90 days after the clinician-sampling appointment date
Adherence to first follow-up step in control group among women referred for follow-up
Quotient of the number of women in control group who adhered to first follow-up step (in this case, colposcopy) divided by the number of women assigned to control group who were referred for follow-up (colposcopy) after an abnormal result in conventional screening
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up
Quotient of the number of women in intervention 1 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 1 group who were referred for follow-up (clinician-sampling) after an abnormal result in self-sampling
Measured: 45 and 90 days after the clinician-sampling appointment date
Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up
Quotient of the number of women in intervention 2 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 2 group who were referred for follow-up (clinician-sampling) after an abnormal result in self-sampling
Measured: 45 and 90 days after the clinician-sampling appointment date
Adherence to colposcopy in control group
Quotient of the number of women in control group who adhered to colposcopy divided by the number of women assigned to control group
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 1 (directly mailed) group
Quotient of the number of women in intervention 1 group who adhered to colposcopy divided by the number of women assigned to intervention 1 group
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 2 (opt-in) group
Quotient of the number of women in intervention 2 group who adhered to colposcopy divided by the number of women assigned to intervention 2 group
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in control group among women referred for colposcopy
Quotient of the number of women in control group who adhered to colposcopy divided by the number of women assigned to control group who were referred for colposcopy after an abnormal result in conventional screening
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy
Quotient of the number of women in intervention 1 group who adhered to colposcopy divided by the number of women assigned to intervention 1 group who were referred for colposcopy after abnormal results in both self-sampling and clinician-sampling
Measured: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy
Quotient of the number of women in intervention 2 group who adhered to colposcopy divided by the number of women assigned to intervention 2 group who were referred for colposcopy after abnormal results in both self-sampling and clinician-sampling
Measured: 45 and 90 days after the colposcopy appointment date
Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group
Adherence will be assessed using Kaplan-Meier survival analysis.
Measured: Follow-up will end at 90 days
Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group
Adherence will be assessed using Kaplan-Meier survival analysis.
Measured: Follow-up will end at 90 days
Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group
Adherence will be assessed using Kaplan-Meier survival analysis.
Measured: Follow-up will end at 90 days
Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group
The quotient of (Number of women in intervention 1 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 1 group) divided by (Number of women in control group who adhered to first follow-up step (in this case, colposcopy) divided by the number of women assigned to control group)
Measured: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group
The quotient of (Number of women in intervention 2 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 2 group) divided by (Number of women in control group who adhered to first follow-up step (in this case, colposcopy) divided by the number of women assigned to control group)
Measured: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up
The quotient of (Number of women in intervention 1 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 1 group who were referred for follow-up (clinician-sampling) after an abnormal result in self-sampling) divided by (Number of women in control group who adhered to first follow-up step (in this case, colposcopy) divided by the number of women assigned to control group who were referred for follow-up (colposcopy) after an abnormal result in conventional screening)
Measured: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up
The quotient of (Number of women in intervention 2 group who adhered to first follow-up step (in this case, clinician-sampling) divided by the number of women assigned to intervention 2 group who were referred for follow-up (clinician-sampling) after an abnormal result in self-sampling) divided by (Number of women in control group who adhered to first follow-up step (in this case, colposcopy) divided by the number of women assigned to control group who were referred for follow-up (colposcopy) after an abnormal result in conventional screening)
Measured: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group
The quotient of (Number of women in intervention 1 group who adhered to colposcopy divided by the number of women assigned to intervention 1 group) divided by (Number of women in control group who adhered to colposcopy divided by the number of women assigned to control group)
Measured: 45 and 90 days after the colposcopy appointment date
Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group
The quotient of (Number of women in intervention 2 group who adhered to colposcopy divided by the number of women assigned to intervention 2 group) divided by (Number of women in control group who adhered to colposcopy divided by the number of women assigned to control group)
Measured: 45 and 90 days after the colposcopy appointment date
Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy
The quotient of (Number of women in intervention 1 group who adhered to colposcopy divided by the number of women assigned to intervention 1 group who were referred for colposcopy after an abnormal result in both self-sampling and clinician-sampling) divided by (Number of women in control group who adhered to colposcopy divided by the number of women assigned to control group who were referred for colposcopy after an abnormal result in conventional screening)
Measured: 45 and 90 days after the colposcopy appointment date
Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy
The quotient of (Number of women in intervention 2 group who adhered to colposcopy divided by the number of women assigned to intervention 2 group who were referred for colposcopy after an abnormal result in both self-sampling and clinician-sampling) divided by (Number of women in control group who adhered to colposcopy divided by the number of women assigned to control group who were referred for colposcopy after an abnormal result in conventional screening)
Measured: 45 and 90 days after the colposcopy appointment date
Proportion of HR-HPV positivity in control group
The quotient of the number of women in control group who tested positive for HR-HPV in conventional screening divided by the number of women assigned to control group
Measured: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV positivity in intervention 1 (directly mailed) group
The quotient of the number of women in intervention 1 group who tested positive for HR-HPV in self-sampling divided by the number of women assigned to intervention 1 group
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV positivity in intervention 2 (opt-in) group
The quotient of the number of women in intervention 2 group who tested positive for HR-HPV in self-sampling divided by the number of women assigned to intervention 2 group
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV positivity in control group among women who adhered to conventional screening
The quotient of the number of women in control group who tested positive for HR-HPV in conventional screening divided by the number of women assigned to control group who adhered to conventional screening
Measured: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample
The quotient of the number of women in intervention 1 group who tested positive for HR-HPV in self-sampling divided by the number of women assigned to intervention 1 group who returned the self-sample
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample
The quotient of the number of women in intervention 2 group who tested positive for HR-HPV in self-sampling divided by the number of women assigned to intervention 2 group who returned the self-sample
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in control group
The quotient of the number of women in control group who tested positive for HR-HPV 16/18 in conventional screening divided by the number of women assigned to control group
Measured: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group
The quotient of the number of women in intervention 1 group who tested positive for HR-HPV 16/18 in self-sampling divided by the number of women assigned to intervention 1 group
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group
The quotient of the number of women in intervention 2 group who tested positive for HR-HPV 16/18 in self-sampling divided by the number of women assigned to intervention 2 group
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening
The quotient of the number of women in control group who tested positive for HR-HPV 16/18 in conventional screening divided by the number of women assigned to control group who adhered to conventional screening
Measured: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample
The quotient of the number of women in intervention 1 group who tested positive for HR-HPV 16/18 in self-sampling divided by the number of women assigned to intervention 1 group who returned the self-sample
Measured: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample
The quotient of the number of women in intervention 2 group who tested positive for HR-HPV 16/18 in self-sampling divided by the number of women assigned to intervention 2 group who returned the self-sample
Measured: 45 and 90 days after the day the self-sampling kit is sent
Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard
The quotient of the number of cases in which both self-sampling and clinician-sampling tested positive for HR-HPV divided by the number of cases in which self-sampling tested positive for HR-HPV, regardless of the clinician-sampling HR-HPV test result)
Measured: 90 days after clinicial-sampling appointment date
Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of the number of self-samples with HR-HPV positive result, abnormal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL
Measured: 90 days after the colposcopy appointment date
Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of the number of self-samples with HR-HPV positive result, normal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL
Measured: 90 days after the colposcopy appointment date
Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (Number of self-samples with HR-HPV positive result, abnormal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL) divided by (The quotient of the number of self-samples with HR-HPV positive result, abnormal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL)
Measured: 90 days after the colposcopy appointment date
Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (Number of self-samples with HR-HPV positive result, normal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL) divided by (The quotient of the number of self-samples with HR-HPV positive result, normal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL)
Measured: 90 days after the colposcopy appointment date
Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (The sum of the number of self-samples with HR-HPV positive result, abnormal methylation result and ≥HSIL with the number of self-samples with HR-HPV positive result, normal methylation result and ≤LSIL) divided by the total number of self-samples with HR-HPV positive result, regardless of the methylation and biopsy results.
Measured: 90 days after the colposcopy appointment date
Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of the number of self-samples with HR-HPV non 16/18 positive result, abnormal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL
Measured: 90 days after the colposcopy appointment date
Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of the number of self-samples with HR-HPV non 16/18 positive result, normal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL
Measured: 90 days after the colposcopy appointment date
Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (Number of self-samples with HR-HPV non 16/18 positive result, abnormal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL) divided by (The quotient of the number of self-samples with HR-HPV non 16/18 positive result, abnormal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL)
Measured: 90 days after the colposcopy appointment date
Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (Number of self-samples with HR-HPV non 16/18 positive result, normal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL) divided by (The quotient of the number of self-samples with HR-HPV non 16/18 positive result, normal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL)
Measured: 90 days after the colposcopy appointment date
Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (The sum of the number of self-samples with HR-HPV non 16/18 positive result, abnormal methylation result and ≥HSIL with the number of self-samples with HR-HPV non 16/18 positive result, normal methylation result and ≤LSIL) divided by the total number of self-samples with HR-HPV non 16/18 positive result, regardless of the methylation and biopsy results.
Measured: 90 days after the colposcopy appointment date
Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of the number of self-samples with HR-HPV 16/18 positive result, abnormal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL
Measured: 90 days after the colposcopy appointment date
Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of the number of self-samples with HR-HPV 16/18 positive result, normal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL
Measured: 90 days after the colposcopy appointment date
Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (Number of self-samples with HR-HPV 16/18 positive result, abnormal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL) divided by (The quotient of the number of self-samples with HR-HPV 16/18 positive result, abnormal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL)
Measured: 90 days after the colposcopy appointment date
Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (Number of self-samples with HR-HPV 16/18 positive result, normal methylation result and ≥HSIL divided by the total number of self-samples with ≥HSIL) divided by (The quotient of the number of self-samples with HR-HPV 16/18 positive result, normal methylation result and ≤LSIL divided by the total number of self-samples with ≤LSIL)
Measured: 90 days after the colposcopy appointment date
Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard
The quotient of (The sum of the number of self-samples with HR-HPV 16/18 positive result, abnormal methylation result and ≥HSIL with the number of self-samples with HR-HPV positive result, normal methylation result and ≤LSIL) divided by the total number of self-samples with HR-HPV 16/18 positive result, regardless of the methylation and biopsy results.
Measured: 90 days after the colposcopy appointment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 Apr 2024
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade de Saúde Familiar de Garcia de Orta, Porto, Unidade de Saúde Familiar da Prelada, Porto, Unidade de Saúde Familiar de Cedofeita, Porto, Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Responsible party
- Principal investigator, Maria Margarida Martins Novais Teixeira, Instituto de Saude Publica da Universidade do Porto
- Investigators
- Maria Margarida MN Teixeira, MD, Principal investigator, Instituto de Saude Publica da Universidade do PortoNuno Lunet, PhD, Study chair, Instituto de Saude Publica da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371118
- Sponsor's protocol ID
- PI 20210032
- Acronym
- HERSELF
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Self-sampling for Women Who do Not Attend the Organized Cervical Cancer Screening Programme (HERSELF)
- ClinicalTrials.gov ID
- NCT06371118
- Acronym / sponsor ID
- HERSELF / PI 20210032
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Unidade de Saúde Familiar de Garcia de Orta, Porto, Unidade de Saúde Familiar da Prelada, Porto, Unidade de Saúde Familiar de Cedofeita, Porto, Instituto Portugues de Oncologia, Francisco Gentil, Porto
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Diagnostic Test: Standard of care - screening in a clinical settingAn invitation to attend a cervical cancer screening in a clinical setting will be sent by post to the woman's address. |
| Intervention 1 (directly mailed group) | Experimental | Device: Directly mailed self-sampling kit to collect a vaginal sampleThe HPV self-sampling test will be sent by post directly to the woman's address. |
| Intervention 2 (opt-in group) | Experimental | Device: Mailed self-sampling kit to collect a vaginal sample after opt-in prodecureThe HPV self-sampling test will be sent by post directly to the woman's address after a opt-in procedure. |
Who may qualify
- Ages
- 26 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged between 26 and 60 years old;
- Women eligible for cervical cancer screening whose screening is at least 1 year overdue.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directly mailed self-sampling kit to collect a vaginal sampleAlso: Evalyn BrushThe 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. | Device | Intervention 1 (directly mailed group) |
| Mailed self-sampling kit to collect a vaginal sample after opt-in prodecureAlso: Evalyn BrushWomen 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. | Device | Intervention 2 (opt-in group) |
| Standard of care - screening in a clinical settingCorresponds 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. | Diagnostic test | Control group |
Primary outcome
Adherence to conventional screening in control group
Time frame: 45 and 90 days after the conventional screening appointment date
Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group
Adherence to HPV self-sampling in intervention 1 (directly mailed) group
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Number of women who returned the self-sample in intervention 1 group divided by the number of women assigned to intervention 1 group
Adherence to HPV self-sampling in intervention 2 (opt-in) group
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Number of women who returned the self-sample in intervention 2 group divided by the number of women assigned to intervention 2 group
Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group
Time frame: 45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate
The quotient of (Number of women in intervention 1 group who returned the self-sample divided by the women assigned to intervention 1 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).
Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group
Time frame: 45 and 90 days after the day the self-sampling kit is sent or 45 and 90 days after the conventional screening appointment date, as appropriate
The quotient of (Number of women in intervention 2 group who returned the self-sample divided by the women assigned to intervention 2 group) dividided by (Number of women in control group who adhered to conventional screening divided by the number of women assigned to control group).
51 secondary outcomes
Adherence to first follow-up step in control group
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to first follow-up step in intervention 1 (directly mailed) group
Time frame: 45 and 90 days after the clinician-sampling appointment date
Adherence to first follow-up step in intervention 2 (opt-in) group
Time frame: 45 and 90 days after the clinician-sampling appointment date
Adherence to first follow-up step in control group among women referred for follow-up
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up
Time frame: 45 and 90 days after the clinician-sampling appointment date
Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up
Time frame: 45 and 90 days after the clinician-sampling appointment date
Adherence to colposcopy in control group
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 1 (directly mailed) group
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 2 (opt-in) group
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in control group among women referred for colposcopy
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy
Time frame: 45 and 90 days after the colposcopy appointment date
Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group
Time frame: Follow-up will end at 90 days
Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group
Time frame: Follow-up will end at 90 days
Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group
Time frame: Follow-up will end at 90 days
Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group
Time frame: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group
Time frame: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up
Time frame: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up
Time frame: 45 and 90 days after the first follow-up step (clinician-sampling appointment date or colposcopy appointment date, as appropriate)
Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy
Time frame: 45 and 90 days after the colposcopy appointment date
Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy
Time frame: 45 and 90 days after the colposcopy appointment date
Proportion of HR-HPV positivity in control group
Time frame: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV positivity in intervention 1 (directly mailed) group
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV positivity in intervention 2 (opt-in) group
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV positivity in control group among women who adhered to conventional screening
Time frame: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in control group
Time frame: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening
Time frame: 45 and 90 days after the conventional screening appointment date
Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample
Time frame: 45 and 90 days after the day the self-sampling kit is sent
Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard
Time frame: 90 days after clinicial-sampling appointment date
Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
Time frame: 90 days after the colposcopy appointment date
Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
Time frame: 90 days after the colposcopy appointment date
Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
Time frame: 90 days after the colposcopy appointment date
Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard
Time frame: 90 days after the colposcopy appointment date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Margarida MN Teixeira, MD principal investigator
Instituto de Saude Publica da Universidade do Porto
Nuno Lunet, PhD study chair
Instituto de Saude Publica da Universidade do Porto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directly mailed self-sampling kit to collect a vaginal sample and Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure in people with Papillomavirus Infections and Early Detection of Cancer, run by Universidade do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Margarida MN Teixeira, Master (00351933099685, margaridat93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to conventional screening in control group (time frame: 45 and 90 days after the conventional screening appointment date). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.