<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/NCT03252769</url>
  </required_header>
  <id_info>
    <org_study_id>WT 15/15</org_study_id>
    <nct_id>NCT03252769</nct_id>
  </id_info>
  <brief_title>Vaginal Self-sampling for Non-attenders</brief_title>
  <official_title>Vaginal Self-sampling for High-risk HPV Detection in Women Who do Not Attend Cervical Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Health and Social Care Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cervical cytology screening coverage in Northern Ireland (the proportion of eligible women,&#xD;
      aged 25-64 years who have had a test result recorded in the previous five years) has&#xD;
      increased steadily since 2005 to 78% in 2012/2013; almost reaching the 80% coverage target.&#xD;
      The uptake of cervical screening among women in the 25-29 year age group in Northern Ireland&#xD;
      however, has remained consistently lower (70-73%) than all other age groups except for the&#xD;
      60-64 year age group where the coverage rate is similar. The main barriers preventing women&#xD;
      from attending for cervical screening are: embarrassment; inconvenience; time and discomfort&#xD;
      associated with obtaining cervical samples. Studies have shown that offering women the&#xD;
      opportunity to collect a vaginal self-sample to test for HPV (the main risk factor for&#xD;
      cervical cancer) could increase screening coverage. Non-attenders in the Western and Belfast&#xD;
      Health and Social Care Trust area, aged 25-29 years, will be identified by GPs. Letters with&#xD;
      information relating to the study and collection devices will be sent to women giving them&#xD;
      two options: 1. inviting them to book a normal screening appointment; 2. inviting them to&#xD;
      collect a self-sample for HPV testing with either a swab or brush collection device.&#xD;
      Participants for receipt of swab or brush will be randomised. Acceptance to participate in&#xD;
      the study will be indicated by signed consent. Returned self-collected samples will be HPV&#xD;
      tested. If a sample is negative, no further investigation is required and the woman will be&#xD;
      encouraged to accept her next screening invitation. If a sample is positive the woman will be&#xD;
      encouraged to book a screening appointment. The study will evaluate: impact on screening&#xD;
      uptake, acceptance of self-sampling for both devices, practicality and cost-effectiveness of&#xD;
      the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women aged 25-29 years who have not attended for cervical screening 9 months after being&#xD;
      called initially will be considered non-attenders and therefore eligible participants. GPs&#xD;
      will identify non-attenders and pass lists to cytology Audit Officers. A group of age-matched&#xD;
      non-attenders will act as controls. Potential participants/controls will be ramdomly&#xD;
      allocated to each group as cases arise. Study packs containing: invitation letters,&#xD;
      participant information, consent forms and HPV self-sampling devices/instructions with return&#xD;
      sample packaging will be sent to non-attenders, 3 months after their GP final reminder, by&#xD;
      the Audit Officers inviting them to participate in the study by collecting a vaginal&#xD;
      self-sample for HPV testing. The letter will contain two options for non-attenders: 1.&#xD;
      inviting them to book a normal screening appointment (non-participation); 2. inviting them to&#xD;
      participate in the study by collecting a self-sample for HPV testing with either a swab or&#xD;
      brush collection device. Potential participants for receipt of swab or brush will be&#xD;
      randomised. The participant information sheet will explain the purpose of the study, how the&#xD;
      test is conducted, by the woman and at the laboratory, how the results will be conveyed to&#xD;
      the woman and her GP and the implications of the HPV test result. The consent form will seek&#xD;
      permission from the woman to process the sample, report the results to the woman, her GP and&#xD;
      the screening office. In addition permission for the research team to check the patient&#xD;
      LabCentre database for subsequent cervical screening results in the event of the woman&#xD;
      testing HPV positive.&#xD;
&#xD;
      Women will return the self-sample to the Cytology laboratory, Altnaelvin in the pre-paid&#xD;
      envelope provided. The sample will be HPV tested by the research team and the results sent to&#xD;
      the woman, her GP and the screening office. Women who test HPV positive will be sent a&#xD;
      results letter and advised to attend for cervical screening. The woman's GP will also be&#xD;
      advised of the management recommendations. Women who test HPV positive will also be given a&#xD;
      helpline number if they wish to discuss their result.&#xD;
&#xD;
      The research team will be responsible for recalling women who test HPV positive for cervical&#xD;
      screening. A reminder letter will be sent to women who test HPV positive if they have not&#xD;
      attended cervical screening 3 months post self-sampling intervention. Women who test HPV&#xD;
      negative do not require further investigation so will be reassured and encouraged to accept&#xD;
      their next screening invitation.&#xD;
&#xD;
      Women who have tested HPV positive but have negative cytology will be offered repeat HPV&#xD;
      testing (GP collected sample) in 12 months and if this is still HPV positive the woman will&#xD;
      be offered a further HPV test 12 months later. The research team will issue these invitations&#xD;
      in conjunction with the woman's GP. Women with a persistent HPV infection will be referred to&#xD;
      colposcopy by the research team.&#xD;
&#xD;
      The number of women returning the self-sampling devices and the number of HPV positive women&#xD;
      attending for subsequent cervical screening will be monitored by the research team. The Audit&#xD;
      Officers will provide anonymised cervical screening uptake data for control groups in order&#xD;
      to ascertain the proportion of cervical screening samples that were obtained as a result of&#xD;
      self-sampling/HPV positivity. Outcomes will be measured at 6 and 12 months post intervention&#xD;
      result.&#xD;
&#xD;
      The study will last 18 months. The end of trial will be when the LabCentre database has been&#xD;
      checked for cervical screening results obtained as a result of the intervention for all&#xD;
      participants at the maximum time limit for return of self-samples plus 3 months to allow for&#xD;
      return of HPV results to participants and recording of any cervical screening results on&#xD;
      LabCentre.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The uptake rate of cervical screening in response to the intervention</measure>
    <time_frame>4 weeks - 6 months</time_frame>
    <description>The uptake rate of cervical screening in response to the intervention</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1950</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Self-sampling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Invitation to self-sample</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-sampling</intervention_name>
    <arm_group_label>Self-sampling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 25-29y and 55-64y&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged below 25y; between 30-54y or aged over 64y&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary McMenamin</last_name>
    <role>Principal Investigator</role>
    <affiliation>WHSCT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary McMenamin</last_name>
    <phone>02871345171</phone>
    <phone_ext>213978</phone_ext>
    <email>mary.mcmenamin2@westhealth.n-i.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>WHSCT</name>
      <address>
        <city>Londonderry</city>
        <state>Northern Ireland</state>
        <zip>BT476SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary McMenamin, PhD</last_name>
      <phone>02871345171</phone>
      <phone_ext>213978</phone_ext>
      <email>mary.mcmenamin2@westhealth.n-i.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>October 2, 2018</last_update_submitted>
  <last_update_submitted_qc>October 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Health and Social Care Trust</investigator_affiliation>
    <investigator_full_name>Dr. Mary McMenamin</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03252769
org study id: WT 15/15
nct id: NCT03252769
lead sponsor: 
has dmc: No
Cervical cytology screening coverage in Northern Ireland (the proportion of eligible women,
      aged 25-64 years who have had a test result recorded in the previous five years) has
      increased steadily since 2005 to 78% in 2012/2013; almost reaching the 80% coverage target.
      The uptake of cervical screening among women in the 25-29 year age group in Northern Ireland
      however, has remained consistently lower (70-73%) than all other age groups except for the
      60-64 year age group where the coverage rate is similar. The main barriers preventing women
      from attending for cervical screening are: embarrassment; inconvenience; time and discomfort
      associated with obtaining cervical samples. Studies have shown that offering women the
      opportunity to collect a vaginal self-sample to test for HPV (the main risk factor for
      cervical cancer) could increase screening coverage. Non-attenders in the Western and Belfast
      Health and Social Care Trust area, aged 25-29 years, will be identified by GPs. Letters with
      information relating to the study and collection devices will be sent to women giving them
      two options: 1. inviting them to book a normal screening appointment; 2. inviting them to
      collect a self-sample for HPV testing with either a swab or brush collection device.
      Participants for receipt of swab or brush will be randomised. Acceptance to participate in
      the study will be indicated by signed consent. Returned self-collected samples will be HPV
      tested. If a sample is negative, no further investigation is required and the woman will be
      encouraged to accept her next screening invitation. If a sample is positive the woman will be
      encouraged to book a screening appointment. The study will evaluate: impact on screening
      uptake, acceptance of self-sampling for both devices, practicality and cost-effectiveness of
      the intervention.
Women aged 25-29 years who have not attended for cervical screening 9 months after being
      called initially will be considered non-attenders and therefore eligible participants. GPs
      will identify non-attenders and pass lists to cytology Audit Officers. A group of age-matched
      non-attenders will act as controls. Potential participants/controls will be ramdomly
      allocated to each group as cases arise. Study packs containing: invitation letters,
      participant information, consent forms and HPV self-sampling devices/instructions with return
      sample packaging will be sent to non-attenders, 3 months after their GP final reminder, by
      the Audit Officers inviting them to participate in the study by collecting a vaginal
      self-sample for HPV testing. The letter will contain two options for non-attenders: 1.
      inviting them to book a normal screening appointment (non-participation); 2. inviting them to
      participate in the study by collecting a self-sample for HPV testing with either a swab or
      brush collection device. Potential participants for receipt of swab or brush will be
      randomised. The participant information sheet will explain the purpose of the study, how the
      test is conducted, by the woman and at the laboratory, how the results will be conveyed to
      the woman and her GP and the implications of the HPV test result. The consent form will seek
      permission from the woman to process the sample, report the results to the woman, her GP and
      the screening office. In addition permission for the research team to check the patient
      LabCentre database for subsequent cervical screening results in the event of the woman
      testing HPV positive.

      Women will return the self-sample to the Cytology laboratory, Altnaelvin in the pre-paid
      envelope provided. The sample will be HPV tested by the research team and the results sent to
      the woman, her GP and the screening office. Women who test HPV positive will be sent a
      results letter and advised to attend for cervical screening. The woman's GP will also be
      advised of the management recommendations. Women who test HPV positive will also be given a
      helpline number if they wish to discuss their result.

      The research team will be responsible for recalling women who test HPV positive for cervical
      screening. A reminder letter will be sent to women who test HPV positive if they have not
      attended cervical screening 3 months post self-sampling intervention. Women who test HPV
      negative do not require further investigation so will be reassured and encouraged to accept
      their next screening invitation.

      Women who have tested HPV positive but have negative cytology will be offered repeat HPV
      testing (GP collected sample) in 12 months and if this is still HPV positive the woman will
      be offered a further HPV test 12 months later. The research team will issue these invitations
      in conjunction with the woman's GP. Women with a persistent HPV infection will be referred to
      colposcopy by the research team.

      The number of women returning the self-sampling devices and the number of HPV positive women
      attending for subsequent cervical screening will be monitored by the research team. The Audit
      Officers will provide anonymised cervical screening uptake data for control groups in order
      to ascertain the proportion of cervical screening samples that were obtained as a result of
      self-sampling/HPV positivity. Outcomes will be measured at 6 and 12 months post intervention
      result.

      The study will last 18 months. The end of trial will be when the LabCentre database has been
      checked for cervical screening results obtained as a result of the intervention for all
      participants at the maximum time limit for return of self-samples plus 3 months to allow for
      return of HPV results to participants and recording of any cervical screening results on
      LabCentre.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The uptake rate of cervical screening in response to the intervention
time frame: 4 weeks - 6 months
description: The uptake rate of cervical screening in response to the intervention
arm group label: Self-sampling
arm group type: Other
description: Invitation to self-sample
intervention type: Other
intervention name: Self-sampling
arm group label: Self-sampling
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mary McMenamin
role: Principal Investigator
affiliation: WHSCT
last name: Mary McMenamin
phone: 02871345171
phone ext: 213978
email: mary.mcmenamin2@westhealth.n-i.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Western Health and Social Care Trust
investigator full name: Dr. Mary McMenamin
investigator title: Dr.
mesh term: Uterine Cervical Neoplasms
sharing ipd: No