<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/NCT03000933</url>
  </required_header>
  <id_info>
    <org_study_id>Merck-54860</org_study_id>
    <nct_id>NCT03000933</nct_id>
  </id_info>
  <brief_title>Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)</brief_title>
  <acronym>HYPER2</acronym>
  <official_title>Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Alfred</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Australia was one of the countries to implement a universal school-based male vaccination&#xD;
      program - in 2013. This research project will examine the prevalence of HPV among young men&#xD;
      who have sex with men (MSM) who have been offered school-based HPV vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HYPER-2, will be a cross-section study, using the same recruitment and testing strategies&#xD;
      used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who&#xD;
      have sex with men aged 16-20 years. Given the differing age groups that will have been&#xD;
      offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first&#xD;
      year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the&#xD;
      participants included in the HYPER-2 study would have been eligible for the free male HPV&#xD;
      vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV&#xD;
      vaccination status for each participant will be verified against the National HPV Vaccination&#xD;
      Program Register.&#xD;
&#xD;
      This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of quadrivalent vaccine HPV types</measure>
    <time_frame>Baseline</time_frame>
    <description>The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Persistent HPV infection</measure>
    <time_frame>Day 7</time_frame>
    <description>Detection of same HPV type at the same site at both visits (day 0 and 7). The objective of repeat sampling at day 7 is to investigate whether this might distinguish transient HPV detection from infection. A brief questionnaire will be self-completed by participants at day 7 to ascertain whether there has been any sexual re-exposure between day 0 and 7 that might explain repeat HPV positivity at day 7.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Human Papillomavirus</condition>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>Young same-sex attracted men</arm_group_label>
    <description>Same-sex attracted men aged 16 to 20</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. Oral sampling for HPV&#xD;
&#xD;
        2. Anal sampling for HPV&amp;&#xD;
&#xD;
        3. Penile sampling for HPV&#xD;
&#xD;
        4. Blood for HPV, HIV, Syphilis&#xD;
&#xD;
        5. Anal swabs for rectal gonorrhoea and chlamydia&#xD;
&#xD;
        6. Pharyngeal swabs for gonorrhoea and chlamydia&#xD;
&#xD;
        7. Urine sample for gonorrhoea and chlamydia&#xD;
&#xD;
      Oral, penile, and anal specimens will be collected from each man at two visits 7 days apart.&#xD;
      Routine HIV and STI (chlamydia, gonorrhoea, and syphilis) screening will be performed at&#xD;
      baseline (Day 0).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Young same sex attracted men 16-20 years of age in Melbourne, Australia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017,&#xD;
             and aged 16-20 years from 1 January 2018 to 31 December 2018)&#xD;
&#xD;
          -  Report any previous type of sexual contact (including but not restricted to oral or&#xD;
             anal sex) with at least one other man ever&#xD;
&#xD;
          -  Able to complete all study requirements including questionnaire in English and&#xD;
             completion of 2 visits&#xD;
&#xD;
          -  Residing in Australia since 2013 (This is to ensure that males included in the study&#xD;
             were present in Australia at the time HPV vaccination was offered)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transgender male&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Melbourne Sexual Health Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <results_reference>
    <citation>Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24.</citation>
    <PMID>34043963</PMID>
  </results_reference>
  <results_reference>
    <citation>Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052. Erratum In: Clin Infect Dis. 2022 Apr 27;:</citation>
    <PMID>34971362</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>October 2, 2022</last_update_submitted>
  <last_update_submitted_qc>October 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Alfred</investigator_affiliation>
    <investigator_full_name>Eric Chow</investigator_full_name>
    <investigator_title>Senior Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Papillomavirus Infections</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/NCT03000933
org study id: Merck-54860
nct id: NCT03000933
lead sponsor: 
collaborator: 
has dmc: No
Australia was one of the countries to implement a universal school-based male vaccination
      program - in 2013. This research project will examine the prevalence of HPV among young men
      who have sex with men (MSM) who have been offered school-based HPV vaccination.
HYPER-2, will be a cross-section study, using the same recruitment and testing strategies
      used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who
      have sex with men aged 16-20 years. Given the differing age groups that will have been
      offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first
      year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the
      participants included in the HYPER-2 study would have been eligible for the free male HPV
      vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV
      vaccination status for each participant will be verified against the National HPV Vaccination
      Program Register.

      This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20
      years.
observational model: Ecologic or Community
time perspective: Prospective
measure: Prevalence of quadrivalent vaccine HPV types
time frame: Baseline
description: The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.
measure: Persistent HPV infection
time frame: Day 7
description: Detection of same HPV type at the same site at both visits (day 0 and 7). The objective of repeat sampling at day 7 is to investigate whether this might distinguish transient HPV detection from infection. A brief questionnaire will be self-completed by participants at day 7 to ascertain whether there has been any sexual re-exposure between day 0 and 7 that might explain repeat HPV positivity at day 7.
arm group label: Young same-sex attracted men
description: Same-sex attracted men aged 16 to 20
1. Oral sampling for HPV

        2. Anal sampling for HPV&

        3. Penile sampling for HPV

        4. Blood for HPV, HIV, Syphilis

        5. Anal swabs for rectal gonorrhoea and chlamydia

        6. Pharyngeal swabs for gonorrhoea and chlamydia

        7. Urine sample for gonorrhoea and chlamydia

      Oral, penile, and anal specimens will be collected from each man at two visits 7 days apart.
      Routine HIV and STI (chlamydia, gonorrhoea, and syphilis) screening will be performed at
      baseline (Day 0).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 16 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
citation: Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24.
PMID: 34043963
citation: Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052. Erratum In: Clin Infect Dis. 2022 Apr 27;:
PMID: 34971362
responsible party type: Principal Investigator
investigator affiliation: The Alfred
investigator full name: Eric Chow
investigator title: Senior Research Fellow
mesh term: Infections
mesh term: Papillomavirus Infections
sharing ipd: No