<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/NCT04430907</url>
  </required_header>
  <id_info>
    <org_study_id>13831</org_study_id>
    <nct_id>NCT04430907</nct_id>
  </id_info>
  <brief_title>HPV Vaccine in Postpartum Women</brief_title>
  <official_title>Increasing Human Papillomavirus Vaccination in Postpartum Women at Penn State Hershey Medical Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the acceptability of HPV vaccination in postpartum&#xD;
      women in Central Pennsylvania. Participants will be recruited while inpatient in the&#xD;
      postpartum unit. Participants will complete a survey asking about knowledge, attitudes, and&#xD;
      beliefs around vaccination, including HPV vaccination, as well as breastfeeding intentions.&#xD;
      After survey completion, the participant will have the option to receive the HPV vaccine,&#xD;
      Gardasil 9, prior to discharge from the hospital. All participants will then be contacted 1-&#xD;
      week later for the follow-up survey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pilot study is to determine if postpartum women serve as a potential&#xD;
      population to target in order to increase human papillomavirus (HPV) vaccination in Central&#xD;
      Pennsylvania.&#xD;
&#xD;
      Despite being available for almost a decade, uptake of the HPV vaccine in the US remains&#xD;
      below other countries, including England, Scotland, and Australia. In fact, in 2017, only 67%&#xD;
      of US girls aged 13-17 had obtained even one dose of the HPV vaccine series. Due to low rates&#xD;
      of HPV vaccination in the United States and Central Pennsylvania, effective interventions are&#xD;
      needed to help increase these rates.&#xD;
&#xD;
      While vaccination is recommended at a younger age, it is effective among women 18-25 years&#xD;
      old. Based on clinical trial data, giving the vaccine to this age group has resulted in&#xD;
      reduced abnormal Pap test findings, referral for colposcopy, and treatment related to&#xD;
      abnormal cervical cytology. However, the HPV vaccine is not usually discussed during prenatal&#xD;
      care or routinely administered during pregnancy. Previous studies have shown that offering&#xD;
      other vaccines postpartum (e.g. tetanus or pertussis) has been successful.&#xD;
&#xD;
      By offering the vaccine to this demographic group, the investigators could potentially&#xD;
      discover an untapped target population to help increase rates of HPV vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Revising protocol.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2021</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2022</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>Prevalence of postpartum women who agree to HPV vaccination</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of HPV vaccination</measure>
    <time_frame>Day 8</time_frame>
    <description>Perception of HPV vaccination as measured via Likert scale questions in pre- and post survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction to receive the HPV vaccine</measure>
    <time_frame>Day 8</time_frame>
    <description>Patient satisfaction with her decision to receive (or not receive) the HPV vaccine as measured via Likert scale questions in pre and post survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of vaccines in general</measure>
    <time_frame>Day 1</time_frame>
    <description>Perception of vaccines overall (not specific to HPV) as measured via Likert scale questions in pre-survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding intentions and practices</measure>
    <time_frame>Days 1 and 8</time_frame>
    <description>Differences in breastfeeding intentions/practices for women who get HPV vaccine in the postpartum setting versus women who refuse HPV vaccine in the postpartum setting as measured by pre- and post-surveys.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>HPV Infection</condition>
  <arm_group>
    <arm_group_label>Vaccine Accepting</arm_group_label>
    <description>This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaccine Rejecting</arm_group_label>
    <description>This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HPV 9-valent Vaccine, Recombinant</intervention_name>
    <description>After consent, participants will complete an intake survey confirming eligibility. Participants will also complete a survey asking about knowledge, attitudes, and beliefs around vaccination, including HPV vaccination, as well as breastfeeding intentions.&#xD;
After survey completion, the participant will be asked if they would like to be administered the HPV vaccine, Gardasil 9. If participants do not agree, they will be contacted 1-week later for the follow-up survey. If participants do agree, the project coordinator will notify the study physician, who will place an order for the vaccine. The vaccine will be administered to the patient prior to discharge from the hospital. Participants will be contacted 1-week later for the follow-up survey.</description>
    <arm_group_label>Vaccine Accepting</arm_group_label>
    <other_name>Gardasil-9</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women postpartum with a live birth at Penn State Hershey Medical Center (PSHMC), either&#xD;
        vaginal or cesarean delivery between the ages of 18-26 (inclusive).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women postpartum with a live birth at Penn State Hershey Medical Center (PSHMC),&#xD;
             either vaginal or cesarean delivery.&#xD;
&#xD;
          2. Women aged 18-26 (inclusive) years&#xD;
&#xD;
          3. Women who are on a Floor Status level of care.&#xD;
&#xD;
          4. Women who have completed 0 or 1 doses of the HPV vaccine STUDY00013831 Approval:&#xD;
             5/8/2020 Page 6 of 24 (V.01/21/2019)&#xD;
&#xD;
          5. Fluent in written and spoken English and other languages in which the Human Subjects&#xD;
             Protection Office (HSPO) Consent Short From is available (French, Italian, Russian,&#xD;
             Spanish, Vietnamese, Hindi, Chinese and Nepali)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who have completed 2 or 3 doses of the HPV vaccine&#xD;
&#xD;
          2. Hypersensitivity, including severe allergic reactions to yeast (a vaccine component),&#xD;
             or after a previous dose of GARDASIL 9 or GARDASIL®.&#xD;
&#xD;
          3. Allergic reaction to amorphous aluminum hydroxyphosphate sulfate or polysorbate 80&#xD;
&#xD;
          4. Women being actively treated for cancer.&#xD;
&#xD;
          5. Have a fever over 100.4 degrees Fahrenheit (38.0 degrees Celsius)&#xD;
&#xD;
          6. Women who are at an ICU level of Care&#xD;
&#xD;
          7. Women who are on a Labor and Delivery Level of Care&#xD;
&#xD;
          8. Women receiving continuous IV magnesium.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacey L Milunic, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State College of Medicine</affiliation>
  </overall_official>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Stacey Milunic</investigator_full_name>
    <investigator_title>Associate Professor, Family and Community Medicine</investigator_title>
  </responsible_party>
  <keyword>HPV vaccination</keyword>
  <keyword>cervical cancer</keyword>
  <keyword>postpartum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04430907
org study id: 13831
nct id: NCT04430907
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to determine the acceptability of HPV vaccination in postpartum
      women in Central Pennsylvania. Participants will be recruited while inpatient in the
      postpartum unit. Participants will complete a survey asking about knowledge, attitudes, and
      beliefs around vaccination, including HPV vaccination, as well as breastfeeding intentions.
      After survey completion, the participant will have the option to receive the HPV vaccine,
      Gardasil 9, prior to discharge from the hospital. All participants will then be contacted 1-
      week later for the follow-up survey.
The purpose of this pilot study is to determine if postpartum women serve as a potential
      population to target in order to increase human papillomavirus (HPV) vaccination in Central
      Pennsylvania.

      Despite being available for almost a decade, uptake of the HPV vaccine in the US remains
      below other countries, including England, Scotland, and Australia. In fact, in 2017, only 67%
      of US girls aged 13-17 had obtained even one dose of the HPV vaccine series. Due to low rates
      of HPV vaccination in the United States and Central Pennsylvania, effective interventions are
      needed to help increase these rates.

      While vaccination is recommended at a younger age, it is effective among women 18-25 years
      old. Based on clinical trial data, giving the vaccine to this age group has resulted in
      reduced abnormal Pap test findings, referral for colposcopy, and treatment related to
      abnormal cervical cytology. However, the HPV vaccine is not usually discussed during prenatal
      care or routinely administered during pregnancy. Previous studies have shown that offering
      other vaccines postpartum (e.g. tetanus or pertussis) has been successful.

      By offering the vaccine to this demographic group, the investigators could potentially
      discover an untapped target population to help increase rates of HPV vaccination.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of postpartum women who agree to HPV vaccination
time frame: Day 1
description: Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting
measure: Perception of HPV vaccination
time frame: Day 8
description: Perception of HPV vaccination as measured via Likert scale questions in pre- and post survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.
measure: Satisfaction to receive the HPV vaccine
time frame: Day 8
description: Patient satisfaction with her decision to receive (or not receive) the HPV vaccine as measured via Likert scale questions in pre and post survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.
measure: Perception of vaccines in general
time frame: Day 1
description: Perception of vaccines overall (not specific to HPV) as measured via Likert scale questions in pre-survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.
measure: Breastfeeding intentions and practices
time frame: Days 1 and 8
description: Differences in breastfeeding intentions/practices for women who get HPV vaccine in the postpartum setting versus women who refuse HPV vaccine in the postpartum setting as measured by pre- and post-surveys.
arm group label: Vaccine Accepting
description: This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.
arm group label: Vaccine Rejecting
description: This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.
intervention type: Biological
intervention name: HPV 9-valent Vaccine, Recombinant
description: After consent, participants will complete an intake survey confirming eligibility. Participants will also complete a survey asking about knowledge, attitudes, and beliefs around vaccination, including HPV vaccination, as well as breastfeeding intentions.
After survey completion, the participant will be asked if they would like to be administered the HPV vaccine, Gardasil 9. If participants do not agree, they will be contacted 1-week later for the follow-up survey. If participants do agree, the project coordinator will notify the study physician, who will place an order for the vaccine. The vaccine will be administered to the patient prior to discharge from the hospital. Participants will be contacted 1-week later for the follow-up survey.
arm group label: Vaccine Accepting
other name: Gardasil-9
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stacey L Milunic, MD
role: Principal Investigator
affiliation: Penn State College of Medicine
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Stacey Milunic
investigator title: Associate Professor, Family and Community Medicine
mesh term: Papillomavirus Infections
sharing ipd: No