<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/NCT03765255</url>
  </required_header>
  <id_info>
    <org_study_id>90AP2688</org_study_id>
    <nct_id>NCT03765255</nct_id>
  </id_info>
  <brief_title>Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth</brief_title>
  <acronym>PREIS</acronym>
  <official_title>Personal Responsibility Education Program Innovative Strategies: Digital Initiative for Youth; An Innovative Youth-Centered Initiative to Improve the Sexual Health and Socio-Economic Well-Being of Youth in Fresno County, California</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Youth+Tech+Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fresno Economic Opportunities Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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 randomized control trial (RCT) will assess an innovative demonstration project to&#xD;
      improve adolescent sexual and reproductive health among highly mobile and marginalized youth&#xD;
      in Fresno County, California. The Digital Initiative for Youth intervention combines&#xD;
      existing, in-person, group-based, comprehensive sexual health education with wraparound&#xD;
      digital technologies. The technological component was designed by Youth+Tech+Health using a&#xD;
      &quot;youth-centered&quot; design approach and the intervention is implemented by Fresno Economic&#xD;
      Opportunities Commission (Fresno EOC). The University of California, San Francisco is the&#xD;
      external evaluator. The RCT will assess health and behavioral outcomes at three time points&#xD;
      (baseline, 4 months, 10 months).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Digital Initiative for Youth (DIY) is an innovative, youth-centered, digital intervention&#xD;
      that aims to improve the health and well-being of adolescents ages 13-19 in Fresno County,&#xD;
      California. In particular, it will address the needs of homeless and unstably housed youth,&#xD;
      youth of color, sexual minority youth, and Native American youth using a trauma-informed&#xD;
      approach and positive youth development framework.&#xD;
&#xD;
      DIY combines existing, in-person, group-based, comprehensive sexual health education with an&#xD;
      app designed in consultation with youth. DIY is built on three strategies: positive youth&#xD;
      development, youth-centered design, and wraparound technologies. It will focus on four main&#xD;
      areas: sexual health and contraceptive use, healthy relationships, educational and career&#xD;
      development, and life skills. The intervention includes six hours of in-person education and&#xD;
      an app that includes a resource locator, goal setting, text message reminders, and additional&#xD;
      information and referrals.&#xD;
&#xD;
      This study is funded through the Personal Responsibility Education Program Innovative&#xD;
      Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of&#xD;
      Health and Human Services,&#xD;
&#xD;
      Fresno EOC is responsible for site and participant recruitment as well as the implementation&#xD;
      of the intervention. Participants are randomized at the cohort (group) level. All control&#xD;
      group participants will be invited to participate after completion of the long-term follow up&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</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>Adolescents will be randomly assigned to treatment or control by cohort (groups of 5-25 adolescents). Adolescents will consent to participation and complete baseline survey prior to randomization. Enrollment will continue by cohort for approximately 2 years. Approximately 15 sites will participate with 2-4 cohorts per site per year.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The adolescents and the staff enrolling the participants will not know of study assignment until after completing recruitment, consent, and baseline. At that point, they will open an envelope stating if it is a control or treatment cohort. The researcher conducting the outcomes analysis will not know enrollment status of an individual.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported condom/contraceptive use or no sex in the last three months on survey</measure>
    <time_frame>Short term follow up (3 months)</time_frame>
    <description>Answered some or all of the time to: In the past 3 months, how often did you or a partner use birth control when you had vaginal sex OR In the past 3 months, how often did you use condoms when you had anal sex? Respondents complete computer-based survey. Survey developed by University of California, San Francisco (UCSF).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported use of any clinic services in the last three months on survey</measure>
    <time_frame>Long-term follow up (9 months)</time_frame>
    <description>Checked any services from survey list after question, &quot;Please check all of the services you have received from a doctor, counselor, therapist, social worker, or clinic in the past 3 months.&quot; Respondents complete computer-based survey. Survey developed by UCSF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported sexual risk behavior on survey</measure>
    <time_frame>Short-term follow up (3 months)</time_frame>
    <description>Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported knowledge of local clinical services on survey</measure>
    <time_frame>Short-term follow up (3 months)</time_frame>
    <description>Answered yes to question on computer-based survey: &quot;Have you heard of a clinic or doctor in your community where teens can get sexual health information and services such as condoms, birth control, pregnancy tests, sexually transmitted infection (STI) tests/treatment, and/or HIV tests?&quot; Survey developed by UCSF.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-reported healthy relationship skills on survey</measure>
    <time_frame>Short-term follow up (3 months)</time_frame>
    <description>Increased number of correct answers on knowledge about healthy relationships questions on computer-based survey between baseline and short-term follow up. Survey developed by UCSF.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported career and education skills on survey</measure>
    <time_frame>Long-term follow up (9 months)</time_frame>
    <description>Respondents answer they are or have been enrolled in career training, internships, or educational support. Respondents complete computer-based survey. Survey developed by UCSF.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported goal setting skills on survey</measure>
    <time_frame>Short-term follow up (3 months)</time_frame>
    <description>Aggregate responses to &quot;worked on an educational and/or career goal&quot; and &quot;made plans to reach your goals&quot; on computer-based survey. Survey developed by UCSF.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1260</enrollment>
  <condition>Reproductive Health</condition>
  <condition>Contraception</condition>
  <condition>Sexually Transmitted Diseases</condition>
  <arm_group>
    <arm_group_label>In the Know (ITK): sexual health education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohorts/participants in the experimental (treatment) arm receive an intervention that combines 6 hours of in-person sexual health and adolescent development education with an app that includes a resource locator, text message reminders (for one month), goal setting, and other resources.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: do not receive ITK intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Cohorts/participants in the no intervention arm do not receive either the in-person education or the app. However, after completing the 10 month survey, they will have access to the app and will be invited to participate in the in-person program after the study implementation phase is completed (years 4 and 5).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In the Know: sexual health education</intervention_name>
    <description>The in-person sessions include modules on: sexual and reproductive health (2 hours - anatomy, gender and sexual orientation, pregnancy, contraception, sexually transmitted infections); healthy relationships and life skills (2 hours - communication and negotiation, consent, violence, online dating, goal setting, strengths); and educational and career success (2 hours - educational and career options, applying for scholarships and financial aid, job readiness, resume preparation, interview skills). The app includes: online referrals, personal life plans/goal setting, text message reminders, quizzes, and other resources.</description>
    <arm_group_label>In the Know (ITK): sexual health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Speak/understand Spanish or English&#xD;
&#xD;
          -  Live within Fresno County, California at baseline (may move out afterward)&#xD;
&#xD;
          -  Age between 13-19&#xD;
&#xD;
          -  Have access to a smart phone or internet (does not need to own)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not live in Fresno County, California at baseline&#xD;
&#xD;
          -  Do not speak or understand Spanish or English&#xD;
&#xD;
          -  Severe mental health issues that prevent them from participating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mara J Decker, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fresno Economic Opportunities Commission</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>youth</keyword>
  <keyword>adolescent</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>Yes</sharing_ipd>
    <ipd_description>We are in discussion with our federal sponsor to determine the sharing plan for a public use dataset.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available on or before October 2021.</ipd_time_frame>
    <ipd_access_criteria>Requirements for access is being developed by the federal sponsors.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03765255/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03765255
org study id: 90AP2688
nct id: NCT03765255
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized control trial (RCT) will assess an innovative demonstration project to
      improve adolescent sexual and reproductive health among highly mobile and marginalized youth
      in Fresno County, California. The Digital Initiative for Youth intervention combines
      existing, in-person, group-based, comprehensive sexual health education with wraparound
      digital technologies. The technological component was designed by Youth+Tech+Health using a
      "youth-centered" design approach and the intervention is implemented by Fresno Economic
      Opportunities Commission (Fresno EOC). The University of California, San Francisco is the
      external evaluator. The RCT will assess health and behavioral outcomes at three time points
      (baseline, 4 months, 10 months).
The Digital Initiative for Youth (DIY) is an innovative, youth-centered, digital intervention
      that aims to improve the health and well-being of adolescents ages 13-19 in Fresno County,
      California. In particular, it will address the needs of homeless and unstably housed youth,
      youth of color, sexual minority youth, and Native American youth using a trauma-informed
      approach and positive youth development framework.

      DIY combines existing, in-person, group-based, comprehensive sexual health education with an
      app designed in consultation with youth. DIY is built on three strategies: positive youth
      development, youth-centered design, and wraparound technologies. It will focus on four main
      areas: sexual health and contraceptive use, healthy relationships, educational and career
      development, and life skills. The intervention includes six hours of in-person education and
      an app that includes a resource locator, goal setting, text message reminders, and additional
      information and referrals.

      This study is funded through the Personal Responsibility Education Program Innovative
      Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of
      Health and Human Services,

      Fresno EOC is responsible for site and participant recruitment as well as the implementation
      of the intervention. Participants are randomized at the cohort (group) level. All control
      group participants will be invited to participate after completion of the long-term follow up
      period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Adolescents will be randomly assigned to treatment or control by cohort (groups of 5-25 adolescents). Adolescents will consent to participation and complete baseline survey prior to randomization. Enrollment will continue by cohort for approximately 2 years. Approximately 15 sites will participate with 2-4 cohorts per site per year.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The adolescents and the staff enrolling the participants will not know of study assignment until after completing recruitment, consent, and baseline. At that point, they will open an envelope stating if it is a control or treatment cohort. The researcher conducting the outcomes analysis will not know enrollment status of an individual.
measure: Self-reported condom/contraceptive use or no sex in the last three months on survey
time frame: Short term follow up (3 months)
description: Answered some or all of the time to: In the past 3 months, how often did you or a partner use birth control when you had vaginal sex OR In the past 3 months, how often did you use condoms when you had anal sex? Respondents complete computer-based survey. Survey developed by University of California, San Francisco (UCSF).
measure: Self-reported use of any clinic services in the last three months on survey
time frame: Long-term follow up (9 months)
description: Checked any services from survey list after question, "Please check all of the services you have received from a doctor, counselor, therapist, social worker, or clinic in the past 3 months." Respondents complete computer-based survey. Survey developed by UCSF.
measure: Self-reported sexual risk behavior on survey
time frame: Short-term follow up (3 months)
description: Respondents provide number of sexual partners in past 3 months on computer-based survey. Survey developed by UCSF.
measure: Self-reported knowledge of local clinical services on survey
time frame: Short-term follow up (3 months)
description: Answered yes to question on computer-based survey: "Have you heard of a clinic or doctor in your community where teens can get sexual health information and services such as condoms, birth control, pregnancy tests, sexually transmitted infection (STI) tests/treatment, and/or HIV tests?" Survey developed by UCSF.
measure: Self-reported healthy relationship skills on survey
time frame: Short-term follow up (3 months)
description: Increased number of correct answers on knowledge about healthy relationships questions on computer-based survey between baseline and short-term follow up. Survey developed by UCSF.
measure: Self-reported career and education skills on survey
time frame: Long-term follow up (9 months)
description: Respondents answer they are or have been enrolled in career training, internships, or educational support. Respondents complete computer-based survey. Survey developed by UCSF.
measure: Self-reported goal setting skills on survey
time frame: Short-term follow up (3 months)
description: Aggregate responses to "worked on an educational and/or career goal" and "made plans to reach your goals" on computer-based survey. Survey developed by UCSF.
arm group label: In the Know (ITK): sexual health education
arm group type: Experimental
description: Cohorts/participants in the experimental (treatment) arm receive an intervention that combines 6 hours of in-person sexual health and adolescent development education with an app that includes a resource locator, text message reminders (for one month), goal setting, and other resources.
arm group label: Control: do not receive ITK intervention
arm group type: No Intervention
description: Cohorts/participants in the no intervention arm do not receive either the in-person education or the app. However, after completing the 10 month survey, they will have access to the app and will be invited to participate in the in-person program after the study implementation phase is completed (years 4 and 5).
intervention type: Other
intervention name: In the Know: sexual health education
description: The in-person sessions include modules on: sexual and reproductive health (2 hours - anatomy, gender and sexual orientation, pregnancy, contraception, sexually transmitted infections); healthy relationships and life skills (2 hours - communication and negotiation, consent, violence, online dating, goal setting, strengths); and educational and career success (2 hours - educational and career options, applying for scholarships and financial aid, job readiness, resume preparation, interview skills). The app includes: online referrals, personal life plans/goal setting, text message reminders, quizzes, and other resources.
arm group label: In the Know (ITK): sexual health education
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mara J Decker, DrPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sexually Transmitted Diseases
sharing ipd: Yes
ipd description: We are in discussion with our federal sponsor to determine the sharing plan for a public use dataset.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available on or before October 2021.
ipd access criteria: Requirements for access is being developed by the federal sponsors.
provided document: 