<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/NCT01698073</url>
  </required_header>
  <id_info>
    <org_study_id>12-0241</org_study_id>
    <nct_id>NCT01698073</nct_id>
  </id_info>
  <brief_title>Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents</brief_title>
  <acronym>COL/AS+</acronym>
  <official_title>Teen Pregnancy Prevention Among Native Youth of the Northern Plains</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Youth who participate in the Circle of Life (COL) program will report less sexual risk taking&#xD;
      behavior compared to youth who do not receive the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Youth who participate in the Circle of Life (COL) program will report less sexual risk taking&#xD;
      behavior and fewer pregnancies compared to youth who do not receive the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ever had sexual intercourse</measure>
    <time_frame>Baseline, 3 months, 1 year</time_frame>
    <description>Ever had sexual intercourse is measured by youth self-reported answers in an online survey to a question on lifetime sexual activity. Specifically, youth are coded &quot;1&quot; if they report having had sex ever before in their lifetimes, &quot;0&quot; otherwise. This question is repeated at each data collection point with youth.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Teen Pregnancy Prevention</condition>
  <arm_group>
    <arm_group_label>mCOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mCircle of Life is a culturally-based HIV-prevention intervention designed for American Indian and Alaska Native 10-12 year-olds. It includes both online and facilitated material.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AS+</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After-School Science Plus is a curriculum designed for youth to teach science and literacy using everyday materials. It helps youth see how science is a part of everyday life and provides role models of scientists who come from different backgrounds and ethnicities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mCOL</intervention_name>
    <arm_group_label>mCOL</arm_group_label>
    <other_name>mCircle of Life</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AS+</intervention_name>
    <arm_group_label>AS+</arm_group_label>
    <other_name>After-School Science Plus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-12 years old at baseline&#xD;
&#xD;
          -  A member of participating Native Boys and Girls Club&#xD;
&#xD;
          -  Signed Parental Consent Form&#xD;
&#xD;
          -  Signed Parental Permission Form&#xD;
&#xD;
          -  Signed Child Assent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None Noted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol E Kaufman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado - Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kaufman CE, Litchfield A, Schupman E, Mitchell CM. Circle of Life HIV/AIDS-prevention intervention for American Indian and Alaska Native youth. Am Indian Alsk Native Ment Health Res. 2012;19(1):140-53. doi: 10.5820/aian.1901.2012.140.</citation>
    <PMID>22569729</PMID>
  </reference>
  <reference>
    <citation>Kaufman CE, Whitesell NR, Keane EM, Desserich JA, Giago C, Sam A, Mitchell CM. Effectiveness of Circle of Life, an HIV-preventive intervention for American Indian middle school youths: a group randomized trial in a Northern Plains tribe. Am J Public Health. 2014 Jun;104(6):e106-12. doi: 10.2105/AJPH.2013.301822. Epub 2014 Apr 22.</citation>
    <PMID>24754555</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>January 7, 2016</last_update_submitted>
  <last_update_submitted_qc>January 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Teen pregnancy prevention</keyword>
  <keyword>American Indian</keyword>
  <keyword>Group-randomized trial</keyword>
  <!-- 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/NCT01698073
org study id: 12-0241
nct id: NCT01698073
lead sponsor: 
has dmc: No
Youth who participate in the Circle of Life (COL) program will report less sexual risk taking
      behavior compared to youth who do not receive the program.
Youth who participate in the Circle of Life (COL) program will report less sexual risk taking
      behavior and fewer pregnancies compared to youth who do not receive the program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Ever had sexual intercourse
time frame: Baseline, 3 months, 1 year
description: Ever had sexual intercourse is measured by youth self-reported answers in an online survey to a question on lifetime sexual activity. Specifically, youth are coded "1" if they report having had sex ever before in their lifetimes, "0" otherwise. This question is repeated at each data collection point with youth.
arm group label: mCOL
arm group type: Experimental
description: mCircle of Life is a culturally-based HIV-prevention intervention designed for American Indian and Alaska Native 10-12 year-olds. It includes both online and facilitated material.
arm group label: AS+
arm group type: Active Comparator
description: After-School Science Plus is a curriculum designed for youth to teach science and literacy using everyday materials. It helps youth see how science is a part of everyday life and provides role models of scientists who come from different backgrounds and ethnicities.
intervention type: Behavioral
intervention name: mCOL
arm group label: mCOL
other name: mCircle of Life
intervention type: Other
intervention name: AS+
arm group label: AS+
other name: After-School Science Plus
criteria: 
gender: All
minimum age: 10 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carol E Kaufman, PhD
role: Principal Investigator
affiliation: University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health
facility: 
country: United States
citation: Kaufman CE, Litchfield A, Schupman E, Mitchell CM. Circle of Life HIV/AIDS-prevention intervention for American Indian and Alaska Native youth. Am Indian Alsk Native Ment Health Res. 2012;19(1):140-53. doi: 10.5820/aian.1901.2012.140.
PMID: 22569729
citation: Kaufman CE, Whitesell NR, Keane EM, Desserich JA, Giago C, Sam A, Mitchell CM. Effectiveness of Circle of Life, an HIV-preventive intervention for American Indian middle school youths: a group randomized trial in a Northern Plains tribe. Am J Public Health. 2014 Jun;104(6):e106-12. doi: 10.2105/AJPH.2013.301822. Epub 2014 Apr 22.
PMID: 24754555
responsible party type: Sponsor