<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/NCT03012932</url>
  </required_header>
  <id_info>
    <org_study_id>20161052</org_study_id>
    <nct_id>NCT03012932</nct_id>
  </id_info>
  <brief_title>HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women</brief_title>
  <official_title>HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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 proposed study will examine the implementation of a Human Papilloma Virus (HPV)&#xD;
      self-sampling intervention for under screened LBQ women living in South Florida. The study&#xD;
      will enroll participants to receive the self-sampling intervention in community venues. The&#xD;
      purpose of this study is to pilot the self-sampler for feasibility and acceptability within&#xD;
      this underserved population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">March 24, 2018</completion_date>
  <primary_completion_date type="Actual">March 24, 2018</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV Self-sampling uptake</measure>
    <time_frame>through study completion, up to 1 year</time_frame>
    <description>Percentage of eligible women who complete HPV self-sampling</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Cervical Cancer Screening</condition>
  <arm_group>
    <arm_group_label>HPV Self-sampling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV self-sampling</intervention_name>
    <description>All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.</description>
    <arm_group_label>HPV Self-sampling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identify as lesbian, bisexual, or queer woman&#xD;
&#xD;
          -  Assigned female sex at birth&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  ages 25-65 years&#xD;
&#xD;
          -  report not having had a pap smear in the last three years (per USPSTF guidelines)&#xD;
&#xD;
          -  if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years&#xD;
             (per USPSTF guidelines)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  report having had a hysterectomy&#xD;
&#xD;
          -  report having history of cervical cancer&#xD;
&#xD;
          -  unable to consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Seay, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>September 24, 2018</last_update_submitted>
  <last_update_submitted_qc>September 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Julia Seay</investigator_full_name>
    <investigator_title>Research Assistant Professor</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/NCT03012932
org study id: 20161052
nct id: NCT03012932
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study will examine the implementation of a Human Papilloma Virus (HPV)
      self-sampling intervention for under screened LBQ women living in South Florida. The study
      will enroll participants to receive the self-sampling intervention in community venues. The
      purpose of this study is to pilot the self-sampler for feasibility and acceptability within
      this underserved population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: HPV Self-sampling uptake
time frame: through study completion, up to 1 year
description: Percentage of eligible women who complete HPV self-sampling
arm group label: HPV Self-sampling
arm group type: Other
description: All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
intervention type: Behavioral
intervention name: HPV self-sampling
description: All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
arm group label: HPV Self-sampling
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Seay, PhD
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Julia Seay
investigator title: Research Assistant Professor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No