<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/NCT03033550</url>
  </required_header>
  <id_info>
    <org_study_id>H-34457</org_study_id>
    <nct_id>NCT03033550</nct_id>
  </id_info>
  <brief_title>Integrating Primary &amp; Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings</brief_title>
  <official_title>A Single-arm Proof of Concept, Open Trial Clinical Study Investigating the Feasibility and Efficacy of Integrating Behavioral and Mobile Health Educational Interventions for Primary and Secondary Prevention in the Primary Care Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a mobile health educational intervention&#xD;
      for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary&#xD;
      Care settings is a feasible behavioral intervention to integrate as a primary and secondary&#xD;
      cervical cancer prevention approach.Study Design: The investigators will conduct an open&#xD;
      feasibility proof-of-concept trial using a single experimental group with all subjects&#xD;
      receiving the behavioral intervention being studied.&#xD;
&#xD;
      Outcome measures. The primary outcome of interest is receipt of the first dose and completion&#xD;
      of the three-dose series of HPV vaccine within 6 month of intervention, this will be&#xD;
      evaluated by Electronic medical review review.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Nearly 80 million people in the US are infected with HPV and 14 million new cases&#xD;
      are diagnosed annually. There is an increasing HPV prevalence among women through the young&#xD;
      adult years. Although the body clears many HPV infections persistent infections can progress&#xD;
      to cancer and other HPV-related diseases. Cervical cancer is the most common cancer caused by&#xD;
      HPV.&#xD;
&#xD;
      Many of the HPV-associated cancers are preventable with a series of safe and effective HPV&#xD;
      vaccines. To date, no state has attained the 80% target vaccination rate for HPV. Despite the&#xD;
      proven benefits and safety of HPV vaccine, usage remains suboptimal (only 38% had completed&#xD;
      the three-dose series) and lower than other recommended adolescent vaccines.&#xD;
&#xD;
      Objective/Hypothesis: Our short term objective is to increase HPV vaccine initiation and&#xD;
      completion rates among all age-eligible adolescent girls for whom vaccine is not&#xD;
      contraindicated; and explore and examine acceptability of providing HPV vaccination to female&#xD;
      youth during her adult female guardian's (AFG) cervical cancer screening appointment.&#xD;
&#xD;
      The investigators hypothesize that a combined intervention which includes (1) a motivational&#xD;
      web-based education aimed at AFGs and youth females in their Primary Care site; and (2) text&#xD;
      message reminders and an informational web-link on HPV vaccine and cervical cancer screening&#xD;
      will increase HPV vaccination rates among youth females and will increase cervical cancer&#xD;
      screening rates among their respective AFGs.&#xD;
&#xD;
      The investigators propose the following Aim:&#xD;
&#xD;
      Specific Aim: Conduct a single-arm proof of concept, open trial clinical study investigating&#xD;
      the feasibility and efficacy of integrating primary and secondary prevention model for HPV&#xD;
      and cervical cancer: a mobile educational and automated electronic interactive messaging&#xD;
      intervention that will remind AFG and youth females of scheduled and missed second and third&#xD;
      HPV vaccination appointments, and deliver brief text and video educational messaging on HPV,&#xD;
      HPV vaccine, and cervical cancer screening.&#xD;
&#xD;
      Study Design: The investigators will conduct an open feasibility proof-of-concept trial using&#xD;
      a single experimental group with all subjects receiving the behavioral intervention being&#xD;
      studied.&#xD;
&#xD;
      Outcome measures. The primary outcome of interest is receipt of the first dose and completion&#xD;
      of the three-dose series of HPV vaccine within 6 month of intervention, this will be&#xD;
      evaluated by Electronic medical review review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Actual">June 8, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The primary outcome of interest is receipt of the first dose and completion of the three or two-dose series of HPV vaccine by participants within 6 month of intervention, this will be evaluated by Electronic Measure Review. Unit of measure: Number of participants who received the first doses and who competed the total number of does based - recorded as percentage who receive the first dose, and completed the two or 3 doses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient knowledge and provider-patient communication</measure>
    <time_frame>over 6 months</time_frame>
    <description>The secondary outcomes are: (a) Change in knowledge of HPV, HPV vaccination, and cervical cancer screening as evaluated by pre/post intervention survey: unit of Measure: based on a 1-10 point scale, with 10 being the highest score;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>provider communication about HPV vaccine</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>greater provider communication about HPV vaccine : Unit of measure- the number of participants who responded yes to provider communication about HPV vaccine</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cervical cancer screening rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Cervical cancer screening rate as evaluated by Electronic Medical Review review: Unit of Measure: Number of participants who has cervical cancer screening within the time guideline ( as measured and reported as percentage who screened within the pap smear guideline</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>HPV-Related Carcinoma</condition>
  <arm_group>
    <arm_group_label>single</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single arm- behavioral educational intervention of a brief negotiated mobile application</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>brief negotiated mobile application</intervention_name>
    <description>The intervention will supplement the standard of care with the following steps: (1) mobile- based brief negotiated Intervention ( BNI); (2) a customized companion communication vaccine report to be given before AFG sees provider; and (3) automated interactive Electronic Recall/Reminder Messages (Text messaging), including text messaging and access to a website which includes information about HPV, HPV Vaccine, and cervical cancer screening guideline.</description>
    <arm_group_label>single</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AFG ages 30 years and older who receive primary care at the study sites.&#xD;
&#xD;
          -  AFG consent to have cervical cancer screening status checked in Electronic Medical&#xD;
             Record.&#xD;
&#xD;
          -  AFG has a daughter between the ages of 11 to 17 who receive primary care at either&#xD;
&#xD;
          -  Family Medicine or Pediatric and Adolescent primary care clinic at Boston Medical&#xD;
             Center.&#xD;
&#xD;
          -  AFG consent to have daughter's HPV vaccination status checked in Electronic Medical&#xD;
             Record.&#xD;
&#xD;
          -  AFG's daughter has neither initiated the HPV vaccine nor completed the three vaccine&#xD;
             series&#xD;
&#xD;
          -  AFG and daughter have the ability to read and write in English.&#xD;
&#xD;
          -  AFG and daughter each have a cell phone with text messages capabilities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigators will exclude based on the following criteria:&#xD;
&#xD;
          -  AFG being seen for a sick visit.&#xD;
&#xD;
          -  AFG has an adolescent daughter who is pregnant or is a mother.&#xD;
&#xD;
          -  AFG has a daughter who has completed the three dose HPV vaccine series.&#xD;
&#xD;
          -  AFG, in the opinion of the clinical staff, is cognitively impaired and unable to give&#xD;
             informed consent and may not participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natalie Joseph, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>July 5, 2018</last_update_submitted>
  <last_update_submitted_qc>July 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Medical Center</investigator_affiliation>
    <investigator_full_name>Natalie Pierre-Joseph</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>HPV vaccination</keyword>
  <keyword>Cervical cancer screening</keyword>
  <keyword>Primary care setting</keyword>
  <keyword>Primary prevention of cervical cancer</keyword>
  <keyword>Secondary prevention of cervical cancer</keyword>
  <keyword>Mobile health information</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03033550
org study id: H-34457
nct id: NCT03033550
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether a mobile health educational intervention
      for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary
      Care settings is a feasible behavioral intervention to integrate as a primary and secondary
      cervical cancer prevention approach.Study Design: The investigators will conduct an open
      feasibility proof-of-concept trial using a single experimental group with all subjects
      receiving the behavioral intervention being studied.

      Outcome measures. The primary outcome of interest is receipt of the first dose and completion
      of the three-dose series of HPV vaccine within 6 month of intervention, this will be
      evaluated by Electronic medical review review.
Background: Nearly 80 million people in the US are infected with HPV and 14 million new cases
      are diagnosed annually. There is an increasing HPV prevalence among women through the young
      adult years. Although the body clears many HPV infections persistent infections can progress
      to cancer and other HPV-related diseases. Cervical cancer is the most common cancer caused by
      HPV.

      Many of the HPV-associated cancers are preventable with a series of safe and effective HPV
      vaccines. To date, no state has attained the 80% target vaccination rate for HPV. Despite the
      proven benefits and safety of HPV vaccine, usage remains suboptimal (only 38% had completed
      the three-dose series) and lower than other recommended adolescent vaccines.

      Objective/Hypothesis: Our short term objective is to increase HPV vaccine initiation and
      completion rates among all age-eligible adolescent girls for whom vaccine is not
      contraindicated; and explore and examine acceptability of providing HPV vaccination to female
      youth during her adult female guardian's (AFG) cervical cancer screening appointment.

      The investigators hypothesize that a combined intervention which includes (1) a motivational
      web-based education aimed at AFGs and youth females in their Primary Care site; and (2) text
      message reminders and an informational web-link on HPV vaccine and cervical cancer screening
      will increase HPV vaccination rates among youth females and will increase cervical cancer
      screening rates among their respective AFGs.

      The investigators propose the following Aim:

      Specific Aim: Conduct a single-arm proof of concept, open trial clinical study investigating
      the feasibility and efficacy of integrating primary and secondary prevention model for HPV
      and cervical cancer: a mobile educational and automated electronic interactive messaging
      intervention that will remind AFG and youth females of scheduled and missed second and third
      HPV vaccination appointments, and deliver brief text and video educational messaging on HPV,
      HPV vaccine, and cervical cancer screening.

      Study Design: The investigators will conduct an open feasibility proof-of-concept trial using
      a single experimental group with all subjects receiving the behavioral intervention being
      studied.

      Outcome measures. The primary outcome of interest is receipt of the first dose and completion
      of the three-dose series of HPV vaccine within 6 month of intervention, this will be
      evaluated by Electronic medical review review.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review
time frame: up to 6 months
description: The primary outcome of interest is receipt of the first dose and completion of the three or two-dose series of HPV vaccine by participants within 6 month of intervention, this will be evaluated by Electronic Measure Review. Unit of measure: Number of participants who received the first doses and who competed the total number of does based - recorded as percentage who receive the first dose, and completed the two or 3 doses.
measure: Patient knowledge and provider-patient communication
time frame: over 6 months
description: The secondary outcomes are: (a) Change in knowledge of HPV, HPV vaccination, and cervical cancer screening as evaluated by pre/post intervention survey: unit of Measure: based on a 1-10 point scale, with 10 being the highest score;
measure: provider communication about HPV vaccine
time frame: through study completion, an average of 1 year
description: greater provider communication about HPV vaccine : Unit of measure- the number of participants who responded yes to provider communication about HPV vaccine
measure: Cervical cancer screening rate
time frame: through study completion, an average of 1 year
description: Cervical cancer screening rate as evaluated by Electronic Medical Review review: Unit of Measure: Number of participants who has cervical cancer screening within the time guideline ( as measured and reported as percentage who screened within the pap smear guideline
arm group label: single
arm group type: Experimental
description: single arm- behavioral educational intervention of a brief negotiated mobile application
intervention type: Behavioral
intervention name: brief negotiated mobile application
description: The intervention will supplement the standard of care with the following steps: (1) mobile- based brief negotiated Intervention ( BNI); (2) a customized companion communication vaccine report to be given before AFG sees provider; and (3) automated interactive Electronic Recall/Reminder Messages (Text messaging), including text messaging and access to a website which includes information about HPV, HPV Vaccine, and cervical cancer screening guideline.
arm group label: single
criteria: 
gender: Female
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Natalie Joseph, MD MPH
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Medical Center
investigator full name: Natalie Pierre-Joseph
investigator title: Assistant Professor of Pediatrics
mesh term: Neoplasm Metastasis
mesh term: Uterine Cervical Neoplasms
sharing ipd: No