<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/NCT02234271</url>
  </required_header>
  <id_info>
    <org_study_id>UCLA_IRB_14-000821</org_study_id>
    <nct_id>NCT02234271</nct_id>
  </id_info>
  <brief_title>Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <brief_summary>
    <textblock>
      The primary objective of the investigators study was to design a comprehensive and medically&#xD;
      accurate contraception counseling mobile health application and evaluate the effects of this&#xD;
      contraception counseling application on the contraceptive methods that patients selected and&#xD;
      their knowledge of that method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contraception choice</measure>
    <time_frame>Participants were followed for the duration of their clinic visit which was up to one day</time_frame>
    <description>Choice of birth control selected by participant was recorded into electronic database system and compared between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of contraception method chosen</measure>
    <time_frame>Participants were followed for the duration of their clinic visit which was up to one day</time_frame>
    <description>A knowledge questionnaire was administered at the end of patient's visit and results were analyzed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Mobile Applications</condition>
  <condition>Contraception</condition>
  <condition>Contraception Behavior</condition>
  <arm_group>
    <arm_group_label>Health Educator Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health Educator for contraception information</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mobile Health Application Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plan A Birth Control - iPad based application for contraception information</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health Application</intervention_name>
    <description>Mobile Health application for contraception information</description>
    <arm_group_label>Mobile Health Application Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Educator Counseling</intervention_name>
    <description>Counseling via health educator</description>
    <arm_group_label>Health Educator Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years of age&#xD;
&#xD;
          -  literate in English&#xD;
&#xD;
          -  not at that time using a contraceptive method&#xD;
&#xD;
          -  willing to switch to a new reversible contraceptive method&#xD;
&#xD;
          -  currently sexually active with a male partner and&#xD;
&#xD;
          -  intending to avoid pregnancy for at least one year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women not at risk for unintended pregnancy&#xD;
&#xD;
          -  those who were pregnant&#xD;
&#xD;
          -  seeking pregnancy within the next 12 months&#xD;
&#xD;
          -  history of surgical sterilization or&#xD;
&#xD;
          -  a current partner who had had a vasectomy&#xD;
&#xD;
          -  using long acting reversible birth control method&#xD;
&#xD;
          -  menopausal&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aparna Sridhar, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Medical Clinic</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>September 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</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>UCLA Women's Health Clinical Research Unit</investigator_full_name>
    <investigator_title>Department of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <!-- 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/NCT02234271
org study id: UCLA_IRB_14-000821
nct id: NCT02234271
lead sponsor: 
The primary objective of the investigators study was to design a comprehensive and medically
      accurate contraception counseling mobile health application and evaluate the effects of this
      contraception counseling application on the contraceptive methods that patients selected and
      their knowledge of that method.
allocation: Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Contraception choice
time frame: Participants were followed for the duration of their clinic visit which was up to one day
description: Choice of birth control selected by participant was recorded into electronic database system and compared between the two groups.
measure: Knowledge of contraception method chosen
time frame: Participants were followed for the duration of their clinic visit which was up to one day
description: A knowledge questionnaire was administered at the end of patient's visit and results were analyzed.
arm group label: Health Educator Arm
arm group type: Active Comparator
description: Health Educator for contraception information
arm group label: Mobile Health Application Arm
arm group type: Experimental
description: Plan A Birth Control - iPad based application for contraception information
intervention type: Other
intervention name: Mobile Health Application
description: Mobile Health application for contraception information
arm group label: Mobile Health Application Arm
intervention type: Other
intervention name: Health Educator Counseling
description: Counseling via health educator
arm group label: Health Educator Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aparna Sridhar, MD, MPH
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: UCLA Women's Health Clinical Research Unit
investigator title: Department of Obstetrics and Gynecology