<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/NCT03759236</url>
  </required_header>
  <id_info>
    <org_study_id>48789</org_study_id>
    <nct_id>NCT03759236</nct_id>
  </id_info>
  <brief_title>Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging</brief_title>
  <official_title>Increasing Human Papillomavirus (HPV) Vaccine Uptake Via General Health Messaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</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>
      Background: Prevention of cervical cancer and genital warts could be achieved by immunization&#xD;
      with the prophylactic human papillomavirus (HPV) vaccines commercially available. However, in&#xD;
      the U.S. only 38% of females and 14% of males in the recommended age group (9-26 years)&#xD;
      receive the complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the&#xD;
      Vaccine for Children Program, the underinsured and uninsured have no-cost access.&#xD;
      Nonetheless, data from Los Angeles county suggest that HPV vaccination rates among the&#xD;
      uninsured and underinsured groups are significantly lower than the national average, likely&#xD;
      related to knowledge of the vaccine, transportation, number of doses and concern of side&#xD;
      effects.&#xD;
&#xD;
      Aim: To evaluate the efficacy of health oriented text messaging to increase HPV vaccine&#xD;
      uptake versus standard health messaging (Center for Disease Control and Prevention (CDC) HPV&#xD;
      vaccine information flyers).&#xD;
&#xD;
      Hypothesis: The investigators hypothesize that receiving general health messaging, including&#xD;
      messages regarding the benefits of the HPV vaccine, will increase HPV vaccine uptake. Text&#xD;
      messaging will also be more successful in reaching the uninsured and underinsured populations&#xD;
      than will traditional flyers/information pamphlets used in clinics.&#xD;
&#xD;
      Methods: A cluster randomized trial design will be used to recruit participants from four&#xD;
      clinics in Los Angeles County which offer pediatric vaccination to uninsured and underinsured&#xD;
      children. The sample will include women aged 18-45 years of age. Two of the sites will be&#xD;
      randomized to the text messaging arm and the other clinic will be randomized to the control&#xD;
      arm (standard messaging: CDC flyers and pamphlets available for patients at the clinic).&#xD;
      Outcome measures will be HPV vaccinations rates at those clinics. Rates will be defined into&#xD;
      groups who received 1 dose, 2 doses and 3 doses.&#xD;
&#xD;
      Anticipated Results: The investigators expect to find statistically significant higher HPV&#xD;
      vaccination rates among children and women in the text messaging study arm compared to the&#xD;
      control arm.&#xD;
&#xD;
      Implications and Future Studies: This pilot study will give us preliminary data to submit a&#xD;
      larger randomized controlled trial to examine the efficacy of text messaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevention of cervical cancer and genital warts could be achieved by immunization with the&#xD;
      prophylactic human papillomavirus (HPV) vaccines commercially available. However, in the U.S.&#xD;
      only 38% of females and 14% of males in the recommended age group (9-26 years) receive the&#xD;
      complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the Vaccine for&#xD;
      Children Program, the underinsured and uninsured have no-cost access. Nonetheless, data from&#xD;
      Los Angeles county suggest that HPV vaccination rates among the uninsured and underinsured&#xD;
      groups are significantly lower than the national average, likely related to knowledge of the&#xD;
      vaccine, transportation, number of doses and concern of side effects. The primary objective&#xD;
      of this pilot study is to evaluate the efficacy of health oriented text messaging to increase&#xD;
      HPV vaccine uptake versus standard health messaging (Center for Disease Control and&#xD;
      Prevention (CDC) HPV vaccine information flyers).&#xD;
&#xD;
      The investigators hypothesize HPV vaccine uptake will be improved through the receipt of&#xD;
      general health messaging that includes HPV vaccine messages. Such messaging will increase&#xD;
      knowledge about HPV vaccine availability, as well as improve the perceptions around HPV&#xD;
      vaccination. Text messaging will also be more successful in reaching large population groups&#xD;
      than traditional flyers/information pamphlets used in clinics.&#xD;
&#xD;
      First, among our three participating clinics, the investigators convened community advisory&#xD;
      boards (CABs) of individuals who are English and Spanish speaking to identify appropriate&#xD;
      text messages including content, length of message and frequency of messaging (once a week,&#xD;
      every other week). Topics included HPV vaccine messages, contraceptive information on&#xD;
      hormonal contraception, long-acting reversible contraceptive (LARC) methods, dysmenorrhea,&#xD;
      frequent menses, and vaginal discharge. The investigators focused on all topics and&#xD;
      specifically messaging of HPV vaccine that are considered neutral and yet compelling. The&#xD;
      investigators built upon the feedback obtained from the CAB. Each clinic serves at least 500&#xD;
      uninsured and underinsured children that offer regular HPV vaccination to these children. Of&#xD;
      these three clinics, two of the sites will be randomized to the intervention arm (text&#xD;
      messaging) and 1 site to have CDC flyers only. The sites currently collect information on all&#xD;
      immunization given at their site. The sites will de-identify their vaccine rates for HPV at&#xD;
      the end of the study and send us the de-identified data sets for vaccine rates, age (not&#xD;
      birth date) and number of nursing/doctor visits made by age group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2018</start_date>
  <completion_date type="Actual">February 19, 2020</completion_date>
  <primary_completion_date type="Actual">February 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two clinics are randomized to receive the health messaging via SMS and the third clinic is randomized to receive standard CDC health education materials.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV Vaccination Rate</measure>
    <time_frame>1 year</time_frame>
    <description>In both arms of the study, we will collect data on the number of females aged 9- 26 years who made any visit to the clinic (denominator) and the number of females aged 9-26 vaccinated (numerator). Vaccination rates will be defined into groups who received at least 1 dose, compared to receiving none. We will also examine those receiving at least 2 doses vs 1 vs none.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Human Papilloma Virus</condition>
  <arm_group>
    <arm_group_label>Health Messaging via SMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinics randomized to this arm will receive the health messaging via SMS intervention. Flyers and information cards will be made available in all exam rooms and the waiting room, which contain information about the health messaging program. Patients must voluntarily elect to enroll in the program using their mobile device. Patients who enroll will receive a variety of health messages on topics including HPV Vaccine, Cervical Cancer screening, Birth Control options, Menstrual Problems, diet and exercise. Text messages are sent out using a third party interface, Twilio, at a frequency of 2 times each week for a duration of 1 year. These are one-way messages which only allow for texts to be sent to the participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CDC Pamphlets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The clinic randomized to this control arm will receive standard Center for Disease Control health pamphlets about the HPV Vaccine. Flyers are posted in the clinic waiting room and exam room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Messaging via SMS</intervention_name>
    <description>This intervention aims to provide health education on topics including HPV Vaccination, Cervical Cancer screening, contraceptive methods, menstrual problems, diet and exercise geared towards women with children of vaccination age.</description>
    <arm_group_label>Health Messaging via SMS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CDC Health Pamphlets</intervention_name>
    <description>This intervention aims to provide health education on the HPV Vaccination to women with children of vaccination age.</description>
    <arm_group_label>CDC Pamphlets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are patients at the clinic&#xD;
&#xD;
          -  Age 18+&#xD;
&#xD;
          -  Have a working mobile phone with SMS capability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  Do not have a working mobile phone with SMS capability&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna-Barbara Moscicki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Anna-Barbara Moscicki, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Health Messaging</keyword>
  <keyword>Health Education</keyword>
  <keyword>Human Papilloma Virus</keyword>
  <keyword>HPV Vaccination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papilloma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03759236
org study id: 48789
nct id: NCT03759236
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Prevention of cervical cancer and genital warts could be achieved by immunization
      with the prophylactic human papillomavirus (HPV) vaccines commercially available. However, in
      the U.S. only 38% of females and 14% of males in the recommended age group (9-26 years)
      receive the complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the
      Vaccine for Children Program, the underinsured and uninsured have no-cost access.
      Nonetheless, data from Los Angeles county suggest that HPV vaccination rates among the
      uninsured and underinsured groups are significantly lower than the national average, likely
      related to knowledge of the vaccine, transportation, number of doses and concern of side
      effects.

      Aim: To evaluate the efficacy of health oriented text messaging to increase HPV vaccine
      uptake versus standard health messaging (Center for Disease Control and Prevention (CDC) HPV
      vaccine information flyers).

      Hypothesis: The investigators hypothesize that receiving general health messaging, including
      messages regarding the benefits of the HPV vaccine, will increase HPV vaccine uptake. Text
      messaging will also be more successful in reaching the uninsured and underinsured populations
      than will traditional flyers/information pamphlets used in clinics.

      Methods: A cluster randomized trial design will be used to recruit participants from four
      clinics in Los Angeles County which offer pediatric vaccination to uninsured and underinsured
      children. The sample will include women aged 18-45 years of age. Two of the sites will be
      randomized to the text messaging arm and the other clinic will be randomized to the control
      arm (standard messaging: CDC flyers and pamphlets available for patients at the clinic).
      Outcome measures will be HPV vaccinations rates at those clinics. Rates will be defined into
      groups who received 1 dose, 2 doses and 3 doses.

      Anticipated Results: The investigators expect to find statistically significant higher HPV
      vaccination rates among children and women in the text messaging study arm compared to the
      control arm.

      Implications and Future Studies: This pilot study will give us preliminary data to submit a
      larger randomized controlled trial to examine the efficacy of text messaging.
Prevention of cervical cancer and genital warts could be achieved by immunization with the
      prophylactic human papillomavirus (HPV) vaccines commercially available. However, in the U.S.
      only 38% of females and 14% of males in the recommended age group (9-26 years) receive the
      complete, three-dose HPV vaccine. Because the HPV vaccine is covered under the Vaccine for
      Children Program, the underinsured and uninsured have no-cost access. Nonetheless, data from
      Los Angeles county suggest that HPV vaccination rates among the uninsured and underinsured
      groups are significantly lower than the national average, likely related to knowledge of the
      vaccine, transportation, number of doses and concern of side effects. The primary objective
      of this pilot study is to evaluate the efficacy of health oriented text messaging to increase
      HPV vaccine uptake versus standard health messaging (Center for Disease Control and
      Prevention (CDC) HPV vaccine information flyers).

      The investigators hypothesize HPV vaccine uptake will be improved through the receipt of
      general health messaging that includes HPV vaccine messages. Such messaging will increase
      knowledge about HPV vaccine availability, as well as improve the perceptions around HPV
      vaccination. Text messaging will also be more successful in reaching large population groups
      than traditional flyers/information pamphlets used in clinics.

      First, among our three participating clinics, the investigators convened community advisory
      boards (CABs) of individuals who are English and Spanish speaking to identify appropriate
      text messages including content, length of message and frequency of messaging (once a week,
      every other week). Topics included HPV vaccine messages, contraceptive information on
      hormonal contraception, long-acting reversible contraceptive (LARC) methods, dysmenorrhea,
      frequent menses, and vaginal discharge. The investigators focused on all topics and
      specifically messaging of HPV vaccine that are considered neutral and yet compelling. The
      investigators built upon the feedback obtained from the CAB. Each clinic serves at least 500
      uninsured and underinsured children that offer regular HPV vaccination to these children. Of
      these three clinics, two of the sites will be randomized to the intervention arm (text
      messaging) and 1 site to have CDC flyers only. The sites currently collect information on all
      immunization given at their site. The sites will de-identify their vaccine rates for HPV at
      the end of the study and send us the de-identified data sets for vaccine rates, age (not
      birth date) and number of nursing/doctor visits made by age group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two clinics are randomized to receive the health messaging via SMS and the third clinic is randomized to receive standard CDC health education materials.
primary purpose: Prevention
masking: None (Open Label)
measure: HPV Vaccination Rate
time frame: 1 year
description: In both arms of the study, we will collect data on the number of females aged 9- 26 years who made any visit to the clinic (denominator) and the number of females aged 9-26 vaccinated (numerator). Vaccination rates will be defined into groups who received at least 1 dose, compared to receiving none. We will also examine those receiving at least 2 doses vs 1 vs none.
arm group label: Health Messaging via SMS
arm group type: Experimental
description: Clinics randomized to this arm will receive the health messaging via SMS intervention. Flyers and information cards will be made available in all exam rooms and the waiting room, which contain information about the health messaging program. Patients must voluntarily elect to enroll in the program using their mobile device. Patients who enroll will receive a variety of health messages on topics including HPV Vaccine, Cervical Cancer screening, Birth Control options, Menstrual Problems, diet and exercise. Text messages are sent out using a third party interface, Twilio, at a frequency of 2 times each week for a duration of 1 year. These are one-way messages which only allow for texts to be sent to the participant.
arm group label: CDC Pamphlets
arm group type: Active Comparator
description: The clinic randomized to this control arm will receive standard Center for Disease Control health pamphlets about the HPV Vaccine. Flyers are posted in the clinic waiting room and exam room.
intervention type: Behavioral
intervention name: Health Messaging via SMS
description: This intervention aims to provide health education on topics including HPV Vaccination, Cervical Cancer screening, contraceptive methods, menstrual problems, diet and exercise geared towards women with children of vaccination age.
arm group label: Health Messaging via SMS
intervention type: Behavioral
intervention name: CDC Health Pamphlets
description: This intervention aims to provide health education on the HPV Vaccination to women with children of vaccination age.
arm group label: CDC Pamphlets
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anna-Barbara Moscicki, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Anna-Barbara Moscicki, MD
investigator title: Principal Investigator
mesh term: Papilloma
sharing ipd: No