<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/NCT02994290</url>
  </required_header>
  <id_info>
    <org_study_id>2000020062</org_study_id>
    <secondary_id>1K07CA230234-01</secondary_id>
    <nct_id>NCT02994290</nct_id>
  </id_info>
  <brief_title>Evaluation of the Implementation and Effectiveness of IPP-HPV</brief_title>
  <official_title>Evaluation of the Implementation and Effectiveness of a Pilot Quality Improvement Program to Increase HPV Vaccine Uptake: Inpatient Postpartum HPV Immunization (IPP-HPV) Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed pilot study is to assess the implementation of IPP-HPV&#xD;
      immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and&#xD;
      facilitators of this intervention to optimize its feasibility and effectiveness. It is&#xD;
      imperative that innovative interventions be developed to achieve comprehensive utilization of&#xD;
      this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and&#xD;
      other HPV associated cancers, and address cancer disparities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Administration of the HPV vaccine during the inpatient postpartum hospital stay has the&#xD;
      potential to be an innovative intervention to improve HPV immunization rates. Following onset&#xD;
      of pregnancy, the postpartum period becomes the next available opportunity to immunize with&#xD;
      the HPV vaccine, which is safe in breastfeeding women. The benefits of such an intervention&#xD;
      include a focus on women engaged with the health care system who are often highly motivated&#xD;
      to invest in their personal health.&#xD;
&#xD;
      Specific Aims Aim 1: To evaluate receptivity and concerns of postpartum women with receiving&#xD;
      the HPV vaccine during the inpatient postpartum admission as part of the Inpatient Postpartum&#xD;
      HPV Immunization Quality Improvement Program (IPP-HPV).&#xD;
&#xD;
      Aim 2: To evaluate receptivity and concerns of healthcare providers with inpatient postpartum&#xD;
      HPV immunization as part of IPP-HPV and to identify facilitators of and barriers to its&#xD;
      implementation.&#xD;
&#xD;
      Aim 3: To assess the uptake and effectiveness of a Pilot Quality Improvement Program to&#xD;
      increase HPV vaccine uptake (IPP-HPV) for Yale New Haven Hospital (YNHH) Women's Center and&#xD;
      Center for Women's Health and Midwifery (CWHM) postpartum patients ≤ 26 years of age who&#xD;
      deliver at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Count of Eligible Patients Agreeing to Receive a Dose of Vaccine</measure>
    <time_frame>12 months</time_frame>
    <description>Data gathered via medical charts for which participants agreed to receive a dose and which did not</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HPV Vaccine Receptivity Thematic Interview</measure>
    <time_frame>up to 6 weeks postpartum</time_frame>
    <description>In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barriers to Receiving the HPV Vaccine Thematic Interview</measure>
    <time_frame>up to 6 weeks postpartum</time_frame>
    <description>In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received or Did Not Receive a Dose of Vaccine</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Data gathered via medical charts for which participants received vaccine as inpatient and which did not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receptivity of Healthcare Providers Thematic Interviews</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concerns of Healthcare Providers Thematic Interview</measure>
    <time_frame>up to 12 months</time_frame>
    <description>The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.</measure>
    <time_frame>12 months postpartum</time_frame>
    <description>Data gathered via medical charts</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">817</enrollment>
  <condition>HPV Vaccination</condition>
  <arm_group>
    <arm_group_label>receive inpatient HPV vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>decline the inpatient dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPV vaccine</intervention_name>
    <description>After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.</description>
    <arm_group_label>receive inpatient HPV vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inpatient Postpartum HPV Immunization Quality Improvement Program</intervention_name>
    <description>The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
    <arm_group_label>decline the inpatient dose</arm_group_label>
    <arm_group_label>receive inpatient HPV vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women participating in the IPP-HPV Quality Improvement Program:&#xD;
&#xD;
          -  Postpartum YNHH Women's Center and CWHM patients&#xD;
&#xD;
          -  ≤ 26 years at time of delivery who deliver at YNHH YSC or SRC&#xD;
&#xD;
          -  Have not already received 3 doses of the HPV vaccine at time of delivery&#xD;
&#xD;
          -  Fluent in English or Spanish&#xD;
&#xD;
          -  Able and willing to provide consent&#xD;
&#xD;
        AND&#xD;
&#xD;
          -  Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and&#xD;
             Midwifery (CWHM) postpartum patients&#xD;
&#xD;
          -  ≤ 26 years of age&#xD;
&#xD;
          -  Delivered at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC) in the first&#xD;
             year of the IPP-HPV program or in the one year preceding implementation of the program&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  YNHH inpatient postpartum nurses or Women's Center outpatient postpartum nurses or&#xD;
             inpatient or outpatient obstetric providers affiliated with the Women's Center or&#xD;
             Center for Women's Health and Midwifery&#xD;
&#xD;
          -  Able and willing to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangini Sheth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital, Women's Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>October 31, 2022</results_first_submitted>
  <results_first_submitted_qc>December 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2023</results_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT02994290/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>787 participants and 30 providers</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Receive Inpatient HPV Vaccine</title>
          <description>The investigators will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
        <group group_id="P2">
          <title>Decline the Inpatient Dose</title>
          <description>The investigators will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
        <group group_id="P3">
          <title>Providers</title>
          <description>Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="491"/>
                <participants group_id="P2" count="296"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="491"/>
                <participants group_id="P2" count="296"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>787 total eligible participants and 30 providers</population>
      <group_list>
        <group group_id="B1">
          <title>Receive Inpatient HPV Vaccine</title>
          <description>The investigators will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until a thematic saturation is reached. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
        <group group_id="B2">
          <title>Decline the Inpatient Dose</title>
          <description>The investigators will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until a thematic saturation is reached. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
        <group group_id="B3">
          <title>Providers</title>
          <description>Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="491"/>
            <count group_id="B2" value="296"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="817"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>mean age in years at delivery</description>
          <population>this is for patient participants</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="491"/>
                    <count group_id="B2" value="296"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.5" spread="2.7"/>
                    <measurement group_id="B2" value="22.5" spread="2.7"/>
                    <measurement group_id="B4" value="22.5" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <population>this data was only collected for providers</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Providers age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;40</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>41-60</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>61+</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Did not report</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>only post-partum women were eligible, data was not collected for providers</description>
          <population>was not collected for providers</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="491"/>
                    <count group_id="B2" value="296"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="491"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="787"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>787 participants and 30 providers</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="491"/>
                    <count group_id="B2" value="296"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="817"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="183"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="265"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="375"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="491"/>
                    <count group_id="B2" value="296"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="817"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="491"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preferred Language</title>
          <description>data was not collected for providers</description>
          <population>this data was only collected for participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="491"/>
                    <count group_id="B2" value="296"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="787"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>English</title>
                  <measurement_list>
                    <measurement group_id="B1" value="244"/>
                    <measurement group_id="B2" value="190"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="434"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Spanish</title>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Providers Job Title</title>
          <description>data was only collected for providers</description>
          <population>this data was only collected for providers</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="30"/>
                    <count group_id="B4" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Registered Nurse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Certified Nurse-Midwife</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Physician</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Physician Assistant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Advanced Practice Registered Nurse</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Count of Eligible Patients Agreeing to Receive a Dose of Vaccine</title>
        <description>Data gathered via medical charts for which participants agreed to receive a dose and which did not</description>
        <time_frame>12 months</time_frame>
        <population>787 total eligible participants</population>
        <group_list>
          <group group_id="O1">
            <title>Eligible to Receive Inpatient HPV Vaccine</title>
            <description>The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group).&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Eligible Patients Agreeing to Receive a Dose of Vaccine</title>
          <description>Data gathered via medical charts for which participants agreed to receive a dose and which did not</description>
          <population>787 total eligible participants</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="787"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Agreed to Receive IPP-HPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not agree to receive IPP-HPV Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>HPV Vaccine Receptivity Thematic Interview</title>
        <description>In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.</description>
        <time_frame>up to 6 weeks postpartum</time_frame>
        <population>a random sub sample of overall participants that completed the thematic interview</population>
        <group_list>
          <group group_id="O1">
            <title>Receive Inpatient HPV Vaccine</title>
            <description>The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
          <group group_id="O2">
            <title>Decline the Inpatient Dose</title>
            <description>The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>HPV Vaccine Receptivity Thematic Interview</title>
          <description>In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.</description>
          <population>a random sub sample of overall participants that completed the thematic interview</population>
          <units>themes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Barriers to Receiving the HPV Vaccine Thematic Interview</title>
        <description>In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.</description>
        <time_frame>up to 6 weeks postpartum</time_frame>
        <population>a random sub sample of participants that completed the thematic interview</population>
        <group_list>
          <group group_id="O1">
            <title>Receive Inpatient HPV Vaccine</title>
            <description>The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
          <group group_id="O2">
            <title>Decline the Inpatient Dose</title>
            <description>The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Barriers to Receiving the HPV Vaccine Thematic Interview</title>
          <description>In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.</description>
          <population>a random sub sample of participants that completed the thematic interview</population>
          <units>themes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received or Did Not Receive a Dose of Vaccine</title>
        <description>Data gathered via medical charts for which participants received vaccine as inpatient and which did not.</description>
        <time_frame>12 months postpartum</time_frame>
        <population>787 total eligible participants</population>
        <group_list>
          <group group_id="O1">
            <title>Eligible to Receive Inpatient HPV Vaccine</title>
            <description>The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group).&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received or Did Not Receive a Dose of Vaccine</title>
          <description>Data gathered via medical charts for which participants received vaccine as inpatient and which did not.</description>
          <population>787 total eligible participants</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="787"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Received IPP-HPV Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not receive IPP-HPV Dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Receptivity of Healthcare Providers Thematic Interviews</title>
        <description>The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.</description>
        <time_frame>up to 12 months</time_frame>
        <population>30 providers</population>
        <group_list>
          <group group_id="O1">
            <title>Providers</title>
            <description>Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Receptivity of Healthcare Providers Thematic Interviews</title>
          <description>The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.</description>
          <population>30 providers</population>
          <units>themes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concerns of Healthcare Providers Thematic Interview</title>
        <description>The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.</description>
        <time_frame>up to 12 months</time_frame>
        <population>30 providers</population>
        <group_list>
          <group group_id="O1">
            <title>Providers</title>
            <description>Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Concerns of Healthcare Providers Thematic Interview</title>
          <description>The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.</description>
          <population>30 providers</population>
          <units>themes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.</title>
        <description>Data gathered via medical charts</description>
        <time_frame>12 months postpartum</time_frame>
        <population>data was not collected for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Eligible to Receive Inpatient HPV Vaccine</title>
            <description>We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.</title>
          <description>Data gathered via medical charts</description>
          <population>data was not collected for this outcome</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse events were not tracked as it was not part of the study protocol</desc>
      <group_list>
        <group group_id="E1">
          <title>Eligible to Receive Inpatient HPV Vaccine</title>
          <description>We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.&#xD;
HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.&#xD;
Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.&#xD;
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.&#xD;
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sangini Sheth</name_or_title>
      <organization>Yale University</organization>
      <phone>203-785-5545</phone>
      <email>Sangini.Sheth@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02994290
org study id: 2000020062
secondary id: 1K07CA230234-01
nct id: NCT02994290
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the proposed pilot study is to assess the implementation of IPP-HPV
      immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and
      facilitators of this intervention to optimize its feasibility and effectiveness. It is
      imperative that innovative interventions be developed to achieve comprehensive utilization of
      this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and
      other HPV associated cancers, and address cancer disparities.
Administration of the HPV vaccine during the inpatient postpartum hospital stay has the
      potential to be an innovative intervention to improve HPV immunization rates. Following onset
      of pregnancy, the postpartum period becomes the next available opportunity to immunize with
      the HPV vaccine, which is safe in breastfeeding women. The benefits of such an intervention
      include a focus on women engaged with the health care system who are often highly motivated
      to invest in their personal health.

      Specific Aims Aim 1: To evaluate receptivity and concerns of postpartum women with receiving
      the HPV vaccine during the inpatient postpartum admission as part of the Inpatient Postpartum
      HPV Immunization Quality Improvement Program (IPP-HPV).

      Aim 2: To evaluate receptivity and concerns of healthcare providers with inpatient postpartum
      HPV immunization as part of IPP-HPV and to identify facilitators of and barriers to its
      implementation.

      Aim 3: To assess the uptake and effectiveness of a Pilot Quality Improvement Program to
      increase HPV vaccine uptake (IPP-HPV) for Yale New Haven Hospital (YNHH) Women's Center and
      Center for Women's Health and Midwifery (CWHM) postpartum patients ≤ 26 years of age who
      deliver at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Count of Eligible Patients Agreeing to Receive a Dose of Vaccine
time frame: 12 months
description: Data gathered via medical charts for which participants agreed to receive a dose and which did not
measure: HPV Vaccine Receptivity Thematic Interview
time frame: up to 6 weeks postpartum
description: In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.
measure: Barriers to Receiving the HPV Vaccine Thematic Interview
time frame: up to 6 weeks postpartum
description: In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.
measure: Number of Participants Who Received or Did Not Receive a Dose of Vaccine
time frame: 12 months postpartum
description: Data gathered via medical charts for which participants received vaccine as inpatient and which did not.
measure: Receptivity of Healthcare Providers Thematic Interviews
time frame: up to 12 months
description: The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.
measure: Concerns of Healthcare Providers Thematic Interview
time frame: up to 12 months
description: The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.
measure: Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.
time frame: 12 months postpartum
description: Data gathered via medical charts
arm group label: receive inpatient HPV vaccine
arm group type: Experimental
description: We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.
arm group label: decline the inpatient dose
arm group type: Experimental
description: We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.
intervention type: Drug
intervention name: HPV vaccine
description: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.
arm group label: receive inpatient HPV vaccine
intervention type: Behavioral
intervention name: Inpatient Postpartum HPV Immunization Quality Improvement Program
description: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.
Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.
All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.
arm group label: decline the inpatient dose
arm group label: receive inpatient HPV vaccine
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 26 Years
healthy volunteers: No
last name: Sangini Sheth, MD
role: Principal Investigator
affiliation: Yale School of Medicine
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 