<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/NCT03774368</url>
  </required_header>
  <id_info>
    <org_study_id>2018P001764</org_study_id>
    <nct_id>NCT03774368</nct_id>
  </id_info>
  <brief_title>Targeted Video Messaging About Emergency Contraception</brief_title>
  <official_title>Targeted Video Messaging About Emergency Contraception Via a Social Media Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Planned Parenthood League of Massachusetts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Planned Parenthood League of Massachusetts</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>
      This research study will assess the real-world effectiveness of Facebook advertising as a&#xD;
      strategy to reach women of reproductive age who are at risk of unintended pregnancy with a&#xD;
      brief educational intervention about emergency contraception (EC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study will assess the real-world effectiveness of Facebook advertising as a&#xD;
      strategy to reach women of reproductive age who are at risk of unintended pregnancy with a&#xD;
      brief educational intervention about emergency contraception (EC). The investigators will&#xD;
      assess whether a video or website link has superior reach, engagement, and return on&#xD;
      investment (measured as cost per click) through a Facebook ad campaign. The investigators&#xD;
      will also ensure that both modalities of consumer engagement (website and video) are&#xD;
      efficacious at ensuring adequate and improved knowledge of emergency contraception through a&#xD;
      laboratory-environment trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">June 7, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency contraception knowledge (binary)</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>This outcome is a binary outcome that reflects a participant's ability to correctly identify an emergency contraceptive method, when to use it, and how to access it</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Copper IUD as emergency contraception knowledge</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>This outcome is a binary outcomes that reflects a participant's ability to correctly identify the copper IUD as emergency contraception, when to use it, and how to access it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levonorgestrel pill as emergency contraception knowledge</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>This outcome is a binary outcomes that reflects a participant's ability to correctly identify the levonorgestrel pill as emergency contraception, when to use it, and how to access it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ulipristal pill as emergency contraception knowledge</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>This outcome is a binary outcomes that reflects a participant's ability to correctly identify the ulipristal pill as emergency contraception, when to use it, and how to access it.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency contraception knowledge (continuous)</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>This outcome reflects the participant's overall knowledge of emergency contraception after the website or video intervention, as measured by the proportion of questions they get correct on the survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emergency contraception knowledge pre- and post-intervention</measure>
    <time_frame>Immediately before and immediately after intervention</time_frame>
    <description>This outcome reflects the participant's change in knowledge of emergency contraception before and after the website or video intervention, as measured by the proportion of questions they get correct on the survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likelihood of using emergency contraception pre- and post-intervention</measure>
    <time_frame>Immediately before and immediately after intervention</time_frame>
    <description>This outcome reflects the participant's likelihood of using emergency contraception both before and after the intervention, as measured on a 6 point likert scale (I would definitely use it, Very likely, Somewhat likely, Somewhat unlikely, Very unlikely, I definitely would NOT use it)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Website about emergency contraception</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects are randomly assigned to view an existing website about emergency contraception. The website contains information about the three methods of emergency contraception: the copper IUD, ulipristal pill, and levonorgestrel pill. It includes information about their relative effectiveness and where to access emergency contraception.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video about emergency contraception</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects are randomly assigned to view an existing video about emergency contraception. The video is two minutes in length and contains information about the three methods of emergency contraception: the copper IUD, ulipristal pill, and levonorgestrel pill. It includes information about their relative effectiveness and where to access emergency contraception.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Emergency contraception website</intervention_name>
    <description>Existing website with factual information about emergency contraception</description>
    <arm_group_label>Website about emergency contraception</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Emergency contraception video</intervention_name>
    <description>Existing video with factual information about emergency contraception</description>
    <arm_group_label>Video about emergency contraception</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  18 to 29 years old&#xD;
&#xD;
          -  Living or seeking care in or around Boston, MA&#xD;
&#xD;
          -  Able to participate in an in-person visit at Planned Parenthood League of&#xD;
             Massachusetts (PPLM) Boston Health Center&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  Have at least one social media account (i.e. Facebook, Instagram, Twitter, Pinterest,&#xD;
             YouTube, Snapchat)&#xD;
&#xD;
          -  Endorse using social media at least once a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PPLM staff&#xD;
&#xD;
          -  Currently or ever employed in the reproductive health field&#xD;
&#xD;
          -  Currently using long-acting reversible contraception (LARC)&#xD;
&#xD;
          -  History of permanent sterilization (by participant or sexual partner)&#xD;
&#xD;
          -  Previous participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Principal Investigator, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Planned Parenthood League of Massachusetts</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PPLM</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT03774368
org study id: 2018P001764
nct id: NCT03774368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study will assess the real-world effectiveness of Facebook advertising as a
      strategy to reach women of reproductive age who are at risk of unintended pregnancy with a
      brief educational intervention about emergency contraception (EC).
This research study will assess the real-world effectiveness of Facebook advertising as a
      strategy to reach women of reproductive age who are at risk of unintended pregnancy with a
      brief educational intervention about emergency contraception (EC). The investigators will
      assess whether a video or website link has superior reach, engagement, and return on
      investment (measured as cost per click) through a Facebook ad campaign. The investigators
      will also ensure that both modalities of consumer engagement (website and video) are
      efficacious at ensuring adequate and improved knowledge of emergency contraception through a
      laboratory-environment trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Emergency contraception knowledge (binary)
time frame: Immediately after intervention
description: This outcome is a binary outcome that reflects a participant's ability to correctly identify an emergency contraceptive method, when to use it, and how to access it
measure: Copper IUD as emergency contraception knowledge
time frame: Immediately after intervention
description: This outcome is a binary outcomes that reflects a participant's ability to correctly identify the copper IUD as emergency contraception, when to use it, and how to access it.
measure: Levonorgestrel pill as emergency contraception knowledge
time frame: Immediately after intervention
description: This outcome is a binary outcomes that reflects a participant's ability to correctly identify the levonorgestrel pill as emergency contraception, when to use it, and how to access it.
measure: Ulipristal pill as emergency contraception knowledge
time frame: Immediately after intervention
description: This outcome is a binary outcomes that reflects a participant's ability to correctly identify the ulipristal pill as emergency contraception, when to use it, and how to access it.
measure: Emergency contraception knowledge (continuous)
time frame: Immediately after intervention
description: This outcome reflects the participant's overall knowledge of emergency contraception after the website or video intervention, as measured by the proportion of questions they get correct on the survey
measure: Change in emergency contraception knowledge pre- and post-intervention
time frame: Immediately before and immediately after intervention
description: This outcome reflects the participant's change in knowledge of emergency contraception before and after the website or video intervention, as measured by the proportion of questions they get correct on the survey.
measure: Likelihood of using emergency contraception pre- and post-intervention
time frame: Immediately before and immediately after intervention
description: This outcome reflects the participant's likelihood of using emergency contraception both before and after the intervention, as measured on a 6 point likert scale (I would definitely use it, Very likely, Somewhat likely, Somewhat unlikely, Very unlikely, I definitely would NOT use it)
arm group label: Website about emergency contraception
arm group type: Other
description: Subjects are randomly assigned to view an existing website about emergency contraception. The website contains information about the three methods of emergency contraception: the copper IUD, ulipristal pill, and levonorgestrel pill. It includes information about their relative effectiveness and where to access emergency contraception.
arm group label: Video about emergency contraception
arm group type: Other
description: Subjects are randomly assigned to view an existing video about emergency contraception. The video is two minutes in length and contains information about the three methods of emergency contraception: the copper IUD, ulipristal pill, and levonorgestrel pill. It includes information about their relative effectiveness and where to access emergency contraception.
intervention type: Other
intervention name: Emergency contraception website
description: Existing website with factual information about emergency contraception
arm group label: Website about emergency contraception
intervention type: Other
intervention name: Emergency contraception video
description: Existing video with factual information about emergency contraception
arm group label: Video about emergency contraception
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Principal Investigator, MD
role: Principal Investigator
affiliation: Planned Parenthood League of Massachusetts
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No