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/NCT05989464</url>
    </required_header>
    <id_info>
      <org_study_id>2022-00672</org_study_id>
      <nct_id>NCT05989464</nct_id>
    </id_info>
    <brief_title>Self-Collected Swabs for Primary Human Papilloma Virus (HPV) Screening</brief_title>
    <official_title>Self-Collected Swabs for Primary Primary Human Papilloma Virus (HPV) Screening</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Hawaii</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Hawaii</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, the investigators will assess whether implementing a self-swab protocol for&#xD;
        primary Human Papilloma Virus (HPV) testing is an effective method to increase cervical&#xD;
        cancer screening in a sample of unscreened women in Hawaii. The findings of this study may&#xD;
        support adoption of HPV self swab protocols both at Kalihi Palama Health Center (KPHC) and&#xD;
        other Federally Qualified Health Centers (FQHC) in Hawaii.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cervical cancer is the fourth most common cancer worldwide. In the United States, the&#xD;
        majority of cervical cancer diagnoses are made in individuals who have not been adequately&#xD;
        screened. Cervical cancer prevention relies on adequate screening using one of three methods:&#xD;
        pap smear cytology, Human Papilloma Virus (HPV) testing alone, or a combination of these two&#xD;
        tests. These screening tests are performed by clinicians comfortable performing a pelvic&#xD;
        exam, most commonly a women's health provider. Currently, less than 60% of individuals with&#xD;
        an indication for cervical cancer screening in the Kalihi Palama Health Center (KPHC) are&#xD;
        up-to-date on their cervical cancer screening test. Even patients who regularly see their&#xD;
        primary care provider (PCP) can face major barriers to attending an appointment with a&#xD;
        women's health provider. These barriers include practical issues such as inability to take&#xD;
        time off, cost concerns, and lack of transportation. Emotional barriers include&#xD;
        embarrassment, lack of privacy, and discomfort associated with the test.&#xD;
  &#xD;
        Self-collected swabs for HPV testing is a proven strategy for populations with low screening&#xD;
        rates. Prior studies have demonstrated increased screening rates for transgender men, African&#xD;
        American women in the Mississippi Delta, and Women From Appalachian Ohio. Studies also&#xD;
        reported patient evaluations of the self-sampling to be comfortable, convenient, and&#xD;
        user-friendly; and one study found a majority preference of self-sampling over&#xD;
        practitioner-sampling for the next screening.&#xD;
  &#xD;
        Self-collected samples have also demonstrated good concordance with practitioner-collected&#xD;
        cervical samples, as seen in multiple studies. The multiple benefits of self-swabbing without&#xD;
        compromising screening accuracy enables the HPV self swab protocol to be an effective&#xD;
        alternative for under screened populations. In fact, multiple countries have adopted national&#xD;
        guidelines for self-sampled HPV screening for either under screened populations or as primary&#xD;
        screening for all women, and more countries are piloting self-sampling to date.&#xD;
  &#xD;
        In this study, the investigators will assess whether implementing a self-swab protocol for&#xD;
        primary HPV testing is an effective method to increase cervical cancer screening in a sample&#xD;
        of unscreened women in Hawaii. The findings of this study may support adoption of HSS&#xD;
        protocols both at (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of swabs with result</measure>
      <time_frame>Within 1 week of swab collection</time_frame>
      <description>Percentage of swabs with result</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants with abnormal result</measure>
      <time_frame>Within 1 week of swab collection</time_frame>
      <description>Percentage of participants with abnormal result</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self reported ease of collecting the swab</measure>
      <time_frame>Immediately after swab is collected</time_frame>
      <description>Self reported ease of collecting the swab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Willingness to collect this swab again in the future</measure>
      <time_frame>Immediately after swab is collected</time_frame>
      <description>Participants will be asked via written questionnaire: &quot;Would you be willing to self collect this swab again in the future?&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self reported level of worry concerning collecting self swab</measure>
      <time_frame>Immediately after swab is collected</time_frame>
      <description>Self reported level of worry concerning collecting self swab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of HPV</measure>
      <time_frame>Immediately after swab is collected</time_frame>
      <description>Participants will be asked a true or false question concerning the prevalence of HPV in the United States on a written questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of cervical cancer</measure>
      <time_frame>Immediately after swab is collected</time_frame>
      <description>Participants will be asked a true or false question concerning the prevalence of cervical cancer in the United States on a written questionnaire.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">84</enrollment>
    <condition>HPV</condition>
    <arm_group>
      <arm_group_label>Human Papilloma Virus (HPV) Self swab</arm_group_label>
      <description>Enrolled participants will be instructed to perform a self swab for genital Human Papilloma Virus (HPV) infection. Additionally, a short survey will be administered to collect demographic information, evaluate knowledge of HPV/cervical cancer, and assess acceptability of HPV self swab.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Self-swab for genital HPV</intervention_name>
      <description>Participants will insert a swab in the vagina to collect a sample for HPV testing.</description>
      <arm_group_label>Human Papilloma Virus (HPV) Self swab</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Self-Collected Vaginal Swabs&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Eligible participants will be identified by their primary care clinician at the Kalihi&#xD;
          Palama Health Center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age of 25 years or older&#xD;
  &#xD;
            -  Have a cervix&#xD;
  &#xD;
            -  Have an indication for cervical cancer screening per Accreditation Council for&#xD;
               Continuing Medical Education (ASCCP) guidelines&#xD;
  &#xD;
            -  Have been previously referred to women's health in the past 5 years or subjects have&#xD;
               declined a women's health referral.&#xD;
  &#xD;
            -  Subjects must not have been seen in women's health clinic since referral was placed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects unable to consent in one of the following languages: English, Chuukese, or&#xD;
               Marshallese&#xD;
  &#xD;
            -  Subjects with known history of cervical cancer&#xD;
  &#xD;
            -  Subjects that are currently pregnant or within 3 months of giving birth&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ann Chang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Hawaii</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jonathan Riel</last_name>
      <phone>(808) 203-6502</phone>
      <email>jriel@hawaii.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Paris Stowers, MD</last_name>
      <email>stowersp@hawaii.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kalihi Palama</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>17460</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ann Chang, MD</last_name>
        <phone>808-222-9305</phone>
        <email>annchang@hawaii.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Hawaii</investigator_affiliation>
      <investigator_full_name>Ann Chang</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>hpv</keyword>
    <keyword>self swab</keyword>
    <keyword>cervical cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Papilloma</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/NCT05989464
  org study id: 2022-00672
  nct id: NCT05989464
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  In this study, the investigators will assess whether implementing a self-swab protocol for
        primary Human Papilloma Virus (HPV) testing is an effective method to increase cervical
        cancer screening in a sample of unscreened women in Hawaii. The findings of this study may
        support adoption of HPV self swab protocols both at Kalihi Palama Health Center (KPHC) and
        other Federally Qualified Health Centers (FQHC) in Hawaii.
  Cervical cancer is the fourth most common cancer worldwide. In the United States, the
        majority of cervical cancer diagnoses are made in individuals who have not been adequately
        screened. Cervical cancer prevention relies on adequate screening using one of three methods:
        pap smear cytology, Human Papilloma Virus (HPV) testing alone, or a combination of these two
        tests. These screening tests are performed by clinicians comfortable performing a pelvic
        exam, most commonly a women's health provider. Currently, less than 60% of individuals with
        an indication for cervical cancer screening in the Kalihi Palama Health Center (KPHC) are
        up-to-date on their cervical cancer screening test. Even patients who regularly see their
        primary care provider (PCP) can face major barriers to attending an appointment with a
        women's health provider. These barriers include practical issues such as inability to take
        time off, cost concerns, and lack of transportation. Emotional barriers include
        embarrassment, lack of privacy, and discomfort associated with the test.
  
        Self-collected swabs for HPV testing is a proven strategy for populations with low screening
        rates. Prior studies have demonstrated increased screening rates for transgender men, African
        American women in the Mississippi Delta, and Women From Appalachian Ohio. Studies also
        reported patient evaluations of the self-sampling to be comfortable, convenient, and
        user-friendly; and one study found a majority preference of self-sampling over
        practitioner-sampling for the next screening.
  
        Self-collected samples have also demonstrated good concordance with practitioner-collected
        cervical samples, as seen in multiple studies. The multiple benefits of self-swabbing without
        compromising screening accuracy enables the HPV self swab protocol to be an effective
        alternative for under screened populations. In fact, multiple countries have adopted national
        guidelines for self-sampled HPV screening for either under screened populations or as primary
        screening for all women, and more countries are piloting self-sampling to date.
  
        In this study, the investigators will assess whether implementing a self-swab protocol for
        primary HPV testing is an effective method to increase cervical cancer screening in a sample
        of unscreened women in Hawaii. The findings of this study may support adoption of HSS
        protocols both at (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.
  observational model: Cohort
  time perspective: Prospective
  measure: Percentage of swabs with result
  time frame: Within 1 week of swab collection
  description: Percentage of swabs with result
  measure: Percentage of participants with abnormal result
  time frame: Within 1 week of swab collection
  description: Percentage of participants with abnormal result
  measure: Self reported ease of collecting the swab
  time frame: Immediately after swab is collected
  description: Self reported ease of collecting the swab
  measure: Willingness to collect this swab again in the future
  time frame: Immediately after swab is collected
  description: Participants will be asked via written questionnaire: "Would you be willing to self collect this swab again in the future?"
  measure: Self reported level of worry concerning collecting self swab
  time frame: Immediately after swab is collected
  description: Self reported level of worry concerning collecting self swab
  measure: Knowledge of HPV
  time frame: Immediately after swab is collected
  description: Participants will be asked a true or false question concerning the prevalence of HPV in the United States on a written questionnaire.
  measure: Knowledge of cervical cancer
  time frame: Immediately after swab is collected
  description: Participants will be asked a true or false question concerning the prevalence of cervical cancer in the United States on a written questionnaire.
  arm group label: Human Papilloma Virus (HPV) Self swab
  description: Enrolled participants will be instructed to perform a self swab for genital Human Papilloma Virus (HPV) infection. Additionally, a short survey will be administered to collect demographic information, evaluate knowledge of HPV/cervical cancer, and assess acceptability of HPV self swab.
  intervention type: Diagnostic Test
  intervention name: Self-swab for genital HPV
  description: Participants will insert a swab in the vagina to collect a sample for HPV testing.
  arm group label: Human Papilloma Virus (HPV) Self swab
  Self-Collected Vaginal Swabs
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 25 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ann Chang, MD
  role: Principal Investigator
  affiliation: University of Hawaii
  last name: Jonathan Riel
  phone: (808) 203-6502
  email: jriel@hawaii.edu
  last name: Paris Stowers, MD
  email: stowersp@hawaii.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Hawaii
  investigator full name: Ann Chang
  investigator title: Associate Professor
  mesh term: Papilloma
  sharing ipd: No