xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05996783</url>
    </required_header>
    <id_info>
      <org_study_id>B3002023000026</org_study_id>
      <nct_id>NCT05996783</nct_id>
    </id_info>
    <brief_title>Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial</brief_title>
    <acronym>ScreenUrSelf</acronym>
    <official_title>Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universiteit Antwerpen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Antwerp University Hospital (UZA)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre for Cancer Detection (CvKO)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sciensano</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universiteit Antwerpen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance and&#xD;
        compliance to follow-up by offering a first-void urine self-sampling alternative to women who&#xD;
        are currently not participating in the organized cervical cancer screening program (defined&#xD;
        in this project as un(der)-screened women), either on the woman or her physician's personal&#xD;
        initiative, or by responding on the invitation letter.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patient: In this population-based study we target real un(der)-screened women, i.e., women&#xD;
        (31-64y) eligible for the Flemish population-based cervical cancer screening program without&#xD;
        any cytology/histology/pathological result retrieved from the Belgian Cancer Registry (BCR)&#xD;
        for at least the last six years (i.e., two screening rounds). Women who opted out of the&#xD;
        screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had)&#xD;
        cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot&#xD;
        projects are not eligible.&#xD;
  &#xD;
        Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish&#xD;
        organized cervical cancer screening program, which is coordinated by CvKO under governance of&#xD;
        the Flemish government. The goal is to reach women who are eligible but do not participate in&#xD;
        cervical cancer screening, by offering two self-sampling methods (first-void urine and&#xD;
        vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for&#xD;
        primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1)&#xD;
        cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test).&#xD;
  &#xD;
        Comparison: The two control arms include 1) no intervention; and 2) sending (recall)&#xD;
        invitation letters to women, inviting them to make an appointment for a Pap smear (i.e.,&#xD;
        current practise within the organized cervical cancer screening program in Flanders).&#xD;
  &#xD;
        Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women&#xD;
        that participate in each intervention and in the control arms at 12 months after initiation&#xD;
        of the intervention (the intervention being one of six study arms). Response in this project&#xD;
        is defined as having a preventive cervical screen exam, either by a self-sample or by a&#xD;
        physician-taken Pap smear, at 12 months after initiation of the intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 25, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Response rate</measure>
      <time_frame>10 months (until 31/03/2024)</time_frame>
      <description>Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.&#xD;
  *PP: participation in intervention arm measured by self-sample analyses only&#xD;
  **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Compliance</measure>
      <time_frame>19 months (until 31/12/2024)</time_frame>
      <description>Compliance to a hrHPV positive result on a self-sample measured by standard of care follow-up, i.e., a Pap smear taken by a clinician.&#xD;
  Compliance to an abnormal Pap smear measured by standard of care follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preference</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Preference and attitudes of women between intervention arms (measured via a questionnaire)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Age-related differences in response rate</measure>
      <time_frame>10 months (until 31/03/2024)</time_frame>
      <description>Age-related differences in response rates within and between different study arms&#xD;
  Response rates: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.&#xD;
  *PP: participation in intervention arm measured by self-sample analyses only&#xD;
  **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Socio-economic status-related differences differences in response rate</measure>
      <time_frame>10 months (until 31/03/2024)</time_frame>
      <description>Socio-economic status-related differences in response rates within and between different study arms&#xD;
  Response rates: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.&#xD;
  *PP: participation in intervention arm measured by self-sample analyses only&#xD;
  **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical accuracy of HPV assay</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ of a hrHPV positive result on a self-sample in un(der)-screened women; absolute measures in each arm and ratios of measures between arms.&#xD;
  Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical accuracy of methylation assay</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate CIN2+ of a methylation-based reflex test (index test) to triage hrHPV positive self-sample in un(der)screened women, compared to reflex cytology on a Pap smear (comparator test); absolute measures in each arm and ratios of measures between arms.&#xD;
  Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Differences in time needed per women to obtain a test result between study arms&#xD;
  Differences in costs per women between the different study arms&#xD;
  Differences in total cost between the different study arms&#xD;
  The above differences in time and costs will be combined to report cost-effectiveness.</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">48000</enrollment>
    <condition>Cervix Cancer</condition>
    <condition>Cervical Intraepithelial Neoplasia</condition>
    <condition>Human Papilloma Virus</condition>
    <condition>HPV-Related Cervical Carcinoma</condition>
    <arm_group>
      <arm_group_label>Control - no intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician.&#xD;
  No reminder letter will be sent.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control - (recall) invitation letter</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening).&#xD;
  A reminder letter will be sent after 5-6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-out first-void urine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a first-void urine self-sampling study package at home.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.&#xD;
  A reminder letter will be sent after 5-6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-in first-void urine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.&#xD;
  A reminder letter will be sent after 5-6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-out vaginal self-sample</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a vaginal self-sampling study package at home.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.&#xD;
  A reminder letter will be sent after 5-6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Opt-in vaginal self-sample</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.&#xD;
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.&#xD;
  A reminder letter will be sent after 5-6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Colli-Pee Small Volumes</intervention_name>
      <description>Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.</description>
      <arm_group_label>Opt-in first-void urine</arm_group_label>
      <arm_group_label>Opt-out first-void urine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Evalyn Brush</intervention_name>
      <description>Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.</description>
      <arm_group_label>Opt-in vaginal self-sample</arm_group_label>
      <arm_group_label>Opt-out vaginal self-sample</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eligible for cervical cancer screening within the organized Population-based Screening&#xD;
               Program in Flanders:&#xD;
  &#xD;
                 -  Female&#xD;
  &#xD;
                 -  Residing in Flanders, Belgium&#xD;
  &#xD;
                 -  Not actively opted out of the organized cervical cancer screening program&#xD;
  &#xD;
                 -  No history of total hysterectomy (data available since 2002)&#xD;
  &#xD;
                 -  No (former) diagnosis of cervical or uterine cancer (data available as of 2008)&#xD;
  &#xD;
                 -  Not included in other CvKO pilot projects&#xD;
  &#xD;
            -  No cervical result registered in the cytohistopathological register of BCR and no&#xD;
               information in the administrative data from health insurance companies (IMA) on PAP&#xD;
               smears taken for at least the last 6 years (i.e., two screening rounds)&#xD;
  &#xD;
            -  31-64 years old (birth year 1959-1992)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being pregnant or 6 weeks postpartum (self-reported after receiving the study&#xD;
               letter/package)&#xD;
  &#xD;
            -  Participation during menstruation or within the 3 following days is a contraindication&#xD;
  &#xD;
            -  Not able to understand the study materials and participation form (informed consent&#xD;
               form)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>31 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pierre Van Damme, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universiteit Antwerpen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Severien Van Keer, MSc, PhD</last_name>
      <phone>03 265 41 92</phone>
      <phone_ext>+32</phone_ext>
      <email>severien.vankeer@uantwerpen.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alex Vorsters, Ir, PhD</last_name>
      <phone>03 265 91 30</phone>
      <phone_ext>+32</phone_ext>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Universiteit Antwerpen</name>
        <address>
          <city>Edegem</city>
          <state>Antwerp</state>
          <zip>2650</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Severien Van Keer, MSc, PhD</last_name>
        <phone>03 265 41 92</phone>
        <phone_ext>+32</phone_ext>
        <email>severien.vankeer@uantwerpen.be</email>
      </contact>
      <contact_backup>
        <last_name>Alex Vorsters, Ir, PhD</last_name>
        <phone>03 265 91 30</phone>
        <phone_ext>+32</phone_ext>
        <email>alex.vorsters@uantwerpen.be</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
      <investigator_full_name>Pierre Van Damme</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Biomarker</keyword>
    <keyword>First-void urine</keyword>
    <keyword>Vaginal sample</keyword>
    <keyword>Screening</keyword>
    <keyword>Triage</keyword>
    <keyword>Self-sampling</keyword>
    <keyword>Prevention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
      <mesh_term>Papilloma</mesh_term>
      <mesh_term>Uterine Cervical Dysplasia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05996783
  org study id: B3002023000026
  nct id: NCT05996783
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance and
        compliance to follow-up by offering a first-void urine self-sampling alternative to women who
        are currently not participating in the organized cervical cancer screening program (defined
        in this project as un(der)-screened women), either on the woman or her physician's personal
        initiative, or by responding on the invitation letter.
  Patient: In this population-based study we target real un(der)-screened women, i.e., women
        (31-64y) eligible for the Flemish population-based cervical cancer screening program without
        any cytology/histology/pathological result retrieved from the Belgian Cancer Registry (BCR)
        for at least the last six years (i.e., two screening rounds). Women who opted out of the
        screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had)
        cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot
        projects are not eligible.
  
        Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish
        organized cervical cancer screening program, which is coordinated by CvKO under governance of
        the Flemish government. The goal is to reach women who are eligible but do not participate in
        cervical cancer screening, by offering two self-sampling methods (first-void urine and
        vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for
        primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1)
        cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test).
  
        Comparison: The two control arms include 1) no intervention; and 2) sending (recall)
        invitation letters to women, inviting them to make an appointment for a Pap smear (i.e.,
        current practise within the organized cervical cancer screening program in Flanders).
  
        Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women
        that participate in each intervention and in the control arms at 12 months after initiation
        of the intervention (the intervention being one of six study arms). Response in this project
        is defined as having a preventive cervical screen exam, either by a self-sample or by a
        physician-taken Pap smear, at 12 months after initiation of the intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Response rate
  time frame: 10 months (until 31/03/2024)
  description: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.
  *PP: participation in intervention arm measured by self-sample analyses only
  **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
  measure: Compliance
  time frame: 19 months (until 31/12/2024)
  description: Compliance to a hrHPV positive result on a self-sample measured by standard of care follow-up, i.e., a Pap smear taken by a clinician.
  Compliance to an abnormal Pap smear measured by standard of care follow-up.
  measure: Preference
  time frame: Through study completion, an average of 1 year
  description: Preference and attitudes of women between intervention arms (measured via a questionnaire)
  measure: Age-related differences in response rate
  time frame: 10 months (until 31/03/2024)
  description: Age-related differences in response rates within and between different study arms
  Response rates: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.
  *PP: participation in intervention arm measured by self-sample analyses only
  **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
  measure: Socio-economic status-related differences differences in response rate
  time frame: 10 months (until 31/03/2024)
  description: Socio-economic status-related differences in response rates within and between different study arms
  Response rates: Proportions of women that participate in each intervention (measured by PP* and ITT*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.
  *PP: participation in intervention arm measured by self-sample analyses only
  **ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken
  measure: Clinical accuracy of HPV assay
  time frame: Through study completion, an average of 1 year
  description: Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ of a hrHPV positive result on a self-sample in un(der)-screened women; absolute measures in each arm and ratios of measures between arms.
  Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.
  measure: Clinical accuracy of methylation assay
  time frame: Through study completion, an average of 1 year
  description: Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate CIN2+ of a methylation-based reflex test (index test) to triage hrHPV positive self-sample in un(der)screened women, compared to reflex cytology on a Pap smear (comparator test); absolute measures in each arm and ratios of measures between arms.
  Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.
  measure: Cost-effectiveness
  time frame: Through study completion, an average of 1 year
  description: Differences in time needed per women to obtain a test result between study arms
  Differences in costs per women between the different study arms
  Differences in total cost between the different study arms
  The above differences in time and costs will be combined to report cost-effectiveness.
  arm group label: Control - no intervention
  arm group type: No Intervention
  description: This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician.
  No reminder letter will be sent.
  arm group label: Control - (recall) invitation letter
  arm group type: No Intervention
  description: This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening).
  A reminder letter will be sent after 5-6 months.
  arm group label: Opt-out first-void urine
  arm group type: Experimental
  description: Women will receive a first-void urine self-sampling study package at home.
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  A reminder letter will be sent after 5-6 months.
  arm group label: Opt-in first-void urine
  arm group type: Experimental
  description: Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.
  The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  A reminder letter will be sent after 5-6 months.
  arm group label: Opt-out vaginal self-sample
  arm group type: Experimental
  description: Women will receive a vaginal self-sampling study package at home.
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  A reminder letter will be sent after 5-6 months.
  arm group label: Opt-in vaginal self-sample
  arm group type: Experimental
  description: Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.
  The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.
  A reminder letter will be sent after 5-6 months.
  intervention type: Device
  intervention name: Colli-Pee Small Volumes
  description: Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
  arm group label: Opt-in first-void urine
  arm group label: Opt-out first-void urine
  intervention type: Device
  intervention name: Evalyn Brush
  description: Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.
  arm group label: Opt-in vaginal self-sample
  arm group label: Opt-out vaginal self-sample
  criteria: 
  gender: Female
  minimum age: 31 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pierre Van Damme, MD, PhD
  role: Principal Investigator
  affiliation: Universiteit Antwerpen
  last name: Severien Van Keer, MSc, PhD
  phone: 03 265 41 92
  phone ext: +32
  email: severien.vankeer@uantwerpen.be
  last name: Alex Vorsters, Ir, PhD
  phone: 03 265 91 30
  phone ext: +32
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: Universiteit Antwerpen
  investigator full name: Pierre Van Damme
  investigator title: Principal Investigator
  mesh term: Uterine Cervical Neoplasms
  mesh term: Papilloma
  mesh term: Uterine Cervical Dysplasia
  sharing ipd: No