<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/NCT03027531</url>
  </required_header>
  <id_info>
    <org_study_id>32030-B</org_study_id>
    <secondary_id>5K23HD052621</secondary_id>
    <nct_id>NCT03027531</nct_id>
  </id_info>
  <brief_title>eKISS: Electronic KIOSK Intervention for Safer-Sex</brief_title>
  <acronym>eKISS</acronym>
  <official_title>eKISS Electronic KIOSK Intervention for Safer-Sex: A Pilot Randomized Controlled Trial of an Interactive Computer-based Intervention for Sexual Health in Adolescents and Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</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 is a randomized controlled trial to test acceptability, feasibility and&#xD;
      preliminary efficacy of an interactive computer-based intervention with individualized&#xD;
      feedback to promote sexual health in adolescents and young adults with assessment of&#xD;
      behavioral and biomarker outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial to test acceptability, feasibility and&#xD;
      preliminary efficacy of an interactive computer-based intervention (ICBI) with individualized&#xD;
      feedback to promote sexual health in adolescents and young adults. The intervention uses&#xD;
      physician avatars and uses elements of motivational interviewing to elicit sexual risk&#xD;
      behaviors and motivation to change risky behavior. Feedback includes instructive video&#xD;
      modules. Participants were asked to identify one behavior to change and were reassessed at&#xD;
      3-month follow-up for interim sexual behavior including condom and birth control use.&#xD;
      Participants were tested for chlamydia, gonorrhea, and pregnancy(females) at baseline and&#xD;
      3-month follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Actual">June 30, 2013</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unprotected sex (no condoms) from self-report via computerized survey</measure>
    <time_frame>during last 2 months (asked at 3 month follow-up visit)</time_frame>
    <description>number of unprotected sex events when participant did not use condom during sex</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unprotected sex (no birth control) from self-report via computerized survey</measure>
    <time_frame>during last 2 months (asked at the 3-month follow-up visit)</time_frame>
    <description>number of unprotected sex events when participant did not use birth control during sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sex partners from self-report via computerized survey</measure>
    <time_frame>during last 2 months (asked at the 3-month follow-up visit)</time_frame>
    <description>number of partners with which the participant had sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers: urine sample tested with nucleic acid amplification test for STDs and urine sample pregnancy test</measure>
    <time_frame>over last 3 months (asked at the 3-month follow-up visit)</time_frame>
    <description>Incident chlamydia, gonorrhea, and pregnancy since baseline visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Reproductive Behavior</condition>
  <condition>Contraception</condition>
  <condition>Sexually Transmitted Diseases</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control group entered sexual history via computer assisted self-interview and provided specimens for chlamydia, gonorrhea and pregnancy(females) testing. The do not receive the feedback intervention of eKISS: electronic KIOSK for safer-sex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group entered sexual history via computer assisted self-interview and received the interactive computer-based intervention with individualized feedback eKISS: electronic KIOSK for safer-sex. They provided specimens for chlamydia, gonorrhea and pregnancy(females) testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eKISS: electronic KIOSK for Safer-Sex</intervention_name>
    <description>An interactive computer-based intervention for safer-sex which provides individualized feedback about protective and risky sexual behaviors; offers instructive video modules for safe-sex; elicits change behavior and identification of behavior change goal using elements of motivational interviewing.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking and reading&#xD;
&#xD;
          -  Report at least one episode of unprotected vaginal sex (no condom OR no birth control)&#xD;
             in the last 2 months&#xD;
&#xD;
          -  Not currently pregnant or actively seeking pregnancy in self or partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently pregnant or actively seeking pregnancy in self or partner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taraneh Shafii, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>King K Holmes, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington; Center for AIDS and STD</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Taraneh Shafii</investigator_full_name>
    <investigator_title>Associate Professor, Department of Pediatrics, Division of Adolescent Medicine</investigator_title>
  </responsible_party>
  <keyword>reproductive health, condoms, sexually transmitted diseases, contraception</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</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/NCT03027531
org study id: 32030-B
secondary id: 5K23HD052621
nct id: NCT03027531
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled trial to test acceptability, feasibility and
      preliminary efficacy of an interactive computer-based intervention with individualized
      feedback to promote sexual health in adolescents and young adults with assessment of
      behavioral and biomarker outcomes.
This study is a randomized controlled trial to test acceptability, feasibility and
      preliminary efficacy of an interactive computer-based intervention (ICBI) with individualized
      feedback to promote sexual health in adolescents and young adults. The intervention uses
      physician avatars and uses elements of motivational interviewing to elicit sexual risk
      behaviors and motivation to change risky behavior. Feedback includes instructive video
      modules. Participants were asked to identify one behavior to change and were reassessed at
      3-month follow-up for interim sexual behavior including condom and birth control use.
      Participants were tested for chlamydia, gonorrhea, and pregnancy(females) at baseline and
      3-month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Unprotected sex (no condoms) from self-report via computerized survey
time frame: during last 2 months (asked at 3 month follow-up visit)
description: number of unprotected sex events when participant did not use condom during sex
measure: Unprotected sex (no birth control) from self-report via computerized survey
time frame: during last 2 months (asked at the 3-month follow-up visit)
description: number of unprotected sex events when participant did not use birth control during sex
measure: Number of sex partners from self-report via computerized survey
time frame: during last 2 months (asked at the 3-month follow-up visit)
description: number of partners with which the participant had sex
measure: Biomarkers: urine sample tested with nucleic acid amplification test for STDs and urine sample pregnancy test
time frame: over last 3 months (asked at the 3-month follow-up visit)
description: Incident chlamydia, gonorrhea, and pregnancy since baseline visit
arm group label: Control
arm group type: Experimental
description: Control group entered sexual history via computer assisted self-interview and provided specimens for chlamydia, gonorrhea and pregnancy(females) testing. The do not receive the feedback intervention of eKISS: electronic KIOSK for safer-sex
arm group label: Intervention
arm group type: Experimental
description: Intervention group entered sexual history via computer assisted self-interview and received the interactive computer-based intervention with individualized feedback eKISS: electronic KIOSK for safer-sex. They provided specimens for chlamydia, gonorrhea and pregnancy(females) testing.
intervention type: Behavioral
intervention name: eKISS: electronic KIOSK for Safer-Sex
description: An interactive computer-based intervention for safer-sex which provides individualized feedback about protective and risky sexual behaviors; offers instructive video modules for safe-sex; elicits change behavior and identification of behavior change goal using elements of motivational interviewing.
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Taraneh Shafii, MD, MPH
role: Principal Investigator
affiliation: University of Washington
last name: King K Holmes, MD, PhD
role: Principal Investigator
affiliation: University of Washington; Center for AIDS and STD
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Taraneh Shafii
investigator title: Associate Professor, Department of Pediatrics, Division of Adolescent Medicine
mesh term: Sexually Transmitted Diseases
sharing ipd: No