<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/NCT03253783</url>
  </required_header>
  <id_info>
    <org_study_id>TP2AH000038</org_study_id>
    <nct_id>NCT03253783</nct_id>
  </id_info>
  <brief_title>The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program</brief_title>
  <official_title>The Evaluation of Pulse: A Mobile Health App and Teen Pregnancy Prevention Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Healthy Teen Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Child Trends</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ewald and Wasserman</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Meta Media</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Healthy Teen Network</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 study uses a randomized controlled design to evaluate the efficacy of a new mobile app,&#xD;
      Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based&#xD;
      mobile health application that can be accessed through mobile smartphones and computers.&#xD;
      Pulse was designed to increase highly effective birth control use and reproductive and sexual&#xD;
      health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of&#xD;
      women with the following characteristics at study enrollment: aged 18-20, not pregnant or&#xD;
      trying to become pregnant, has daily access to a smartphone, currently living in the United&#xD;
      States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at&#xD;
      least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to&#xD;
      enroll up to 1,300 participants over a one-year enrollment period using social media,&#xD;
      including Facebook, Instagram, and Twitter.&#xD;
&#xD;
      Users access Pulse autonomously, on their own terms, and in their own time and place. The app&#xD;
      consists of 6 sections and includes 3 hours of unique content. It does not require the user&#xD;
      to follow a specific sequence of content viewed; however, all users will receive a monetary&#xD;
      incentive after registering with the apps. Youth randomized to the intervention condition are&#xD;
      given access to Pulse indefinitely and receive daily text messages related to sexual health&#xD;
      for 6 weeks. Control participants are directed to a free general health/fitness web-based&#xD;
      mobile application, also called Pulse, and receive text messages related to general health&#xD;
      for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain&#xD;
      different content. Participants in both the intervention and comparison groups receive a&#xD;
      baseline survey and a 6-week follow-up survey. Participants will also receive incentives once&#xD;
      they complete the baseline and post-intervention survey. Both surveys are conducted online&#xD;
      via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of&#xD;
      New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of&#xD;
      Health and Human Services' Office of Adolescent Health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unprotected sex, no contraceptive</measure>
    <time_frame>6-week post-baseline (in the past 6 weeks)</time_frame>
    <description>Ever having sexual intercourse without using any method of contraception (among full sample)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unprotected sex, no highly effective contraceptive</measure>
    <time_frame>6-week post-baseline (in the past 6 weeks)</time_frame>
    <description>Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reproductive and sexual health care utilization (among full sample)</measure>
    <time_frame>6-weeks post-baseline</time_frame>
    <description>Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey</description>
  </secondary_outcome>
  <enrollment type="Actual">1304</enrollment>
  <condition>Unprotected Sex</condition>
  <condition>Contraceptive Usage</condition>
  <condition>Reproductive and Sexual Health Care Utilization</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pulse</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: Female&#xD;
&#xD;
          -  Age Limit: 18-20&#xD;
&#xD;
          -  Must have daily access to a smartphone that receives text messages and can access to&#xD;
             the Internet&#xD;
&#xD;
          -  Must speak English or Spanish&#xD;
&#xD;
          -  Must live in the United States or a U.S. territory&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or trying to get pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Genevieve Martinez-Garcia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Healthy Teen Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Manlove, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Child Trends</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healthy Teen Network</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Healthy Teen Network</investigator_affiliation>
    <investigator_full_name>Martinez Garcia</investigator_full_name>
    <investigator_title>Dr. Genevieve Martínez-García</investigator_title>
  </responsible_party>
  <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/NCT03253783
org study id: TP2AH000038
nct id: NCT03253783
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study uses a randomized controlled design to evaluate the efficacy of a new mobile app,
      Pulse, in reducing the incidence of unprotected sex among young women. Pulse is a web-based
      mobile health application that can be accessed through mobile smartphones and computers.
      Pulse was designed to increase highly effective birth control use and reproductive and sexual
      health care utilization, and ultimately decrease teen pregnancy. The sample is comprised of
      women with the following characteristics at study enrollment: aged 18-20, not pregnant or
      trying to become pregnant, has daily access to a smartphone, currently living in the United
      States or a U.S. territory, and speaks either English or Spanish. Most of the sample (at
      least 70%) will be women who identify as Black and/or Latina. The evaluation team plans to
      enroll up to 1,300 participants over a one-year enrollment period using social media,
      including Facebook, Instagram, and Twitter.

      Users access Pulse autonomously, on their own terms, and in their own time and place. The app
      consists of 6 sections and includes 3 hours of unique content. It does not require the user
      to follow a specific sequence of content viewed; however, all users will receive a monetary
      incentive after registering with the apps. Youth randomized to the intervention condition are
      given access to Pulse indefinitely and receive daily text messages related to sexual health
      for 6 weeks. Control participants are directed to a free general health/fitness web-based
      mobile application, also called Pulse, and receive text messages related to general health
      for 6 weeks. The control and treatment apps look and feel similar aesthetically but contain
      different content. Participants in both the intervention and comparison groups receive a
      baseline survey and a 6-week follow-up survey. Participants will also receive incentives once
      they complete the baseline and post-intervention survey. Both surveys are conducted online
      via an electronic survey platform. This study is being conducted as a Rigorous Evaluation of
      New or Innovative Approaches to Prevent Teen Pregnancy funded by the U.S. Department of
      Health and Human Services' Office of Adolescent Health.
primary purpose: Prevention
masking: None (Open Label)
measure: Unprotected sex, no contraceptive
time frame: 6-week post-baseline (in the past 6 weeks)
description: Ever having sexual intercourse without using any method of contraception (among full sample)
measure: Unprotected sex, no highly effective contraceptive
time frame: 6-week post-baseline (in the past 6 weeks)
description: Ever having sexual intercourse without using a hormonal or LARC method of contraception (among full sample)
measure: Reproductive and sexual health care utilization (among full sample)
time frame: 6-weeks post-baseline
description: Visiting a health care provider for reproductive or sexual health services within the past 6 weeks for the 1st follow-up survey
intervention type: Behavioral
intervention name: Pulse
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Genevieve Martinez-Garcia, PhD
role: Principal Investigator
affiliation: Healthy Teen Network
last name: Jennifer Manlove, PhD
role: Principal Investigator
affiliation: Child Trends
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Healthy Teen Network
investigator full name: Martinez Garcia
investigator title: Dr. Genevieve Martínez-García
sharing ipd: No