<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/NCT02188797</url>
  </required_header>
  <id_info>
    <org_study_id>R34DA034813</org_study_id>
    <nct_id>NCT02188797</nct_id>
  </id_info>
  <brief_title>Substance Use and Sexual Risk Reduction Intervention for Homeless Youth</brief_title>
  <official_title>Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered&#xD;
      risk reduction program for homeless young adults. It is hypothesized that youth who&#xD;
      participate in the program will show greater reductions in substance use intentions, behavior&#xD;
      and consequences, as well as sexual activity intentions and risk behavior, over a 3-month&#xD;
      period compared to a usual care control sample of youth who do not participate in the&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study addresses an important gap in prevention services for homeless youth by conducting&#xD;
      a pilot test of an innovative 4-session integrated substance use and sexual risk reduction&#xD;
      program for this population that is feasible to deliver in settings where these youth seek&#xD;
      services. The study has 2 specific aims:&#xD;
&#xD;
      Aim 1: Investigate whether homeless youth who participate in the program show reductions in&#xD;
      substance use and intentions, behavior and consequences, as well as sexual activity&#xD;
      intentions and risk behavior, over a 3-month period compared to a usual care control sample&#xD;
      of youth who do not receive the program.&#xD;
&#xD;
      Aim 2: Gain a better understanding of intervention effects by exploring whether improvements&#xD;
      in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance&#xD;
      use and offers serve as explanatory mechanisms for reductions in substance use- and sexual&#xD;
      activity- related intentions and risk behaviors among youth who participate in the program.&#xD;
&#xD;
      The program will be evaluated using a form of group-randomized design, although with&#xD;
      crossover of conditions and groups to avoid the problems of power reduction associated with&#xD;
      conventional group randomization. The unit of analysis will be the individual, but&#xD;
      individuals will be assigned to groups based on the agency where they are seeking services.&#xD;
      Youth at two drop-in centers serving homeless youth will either be in the intervention&#xD;
      condition or a &quot;usual care&quot; control condition. The field period will be divided into four&#xD;
      phases. The two agencies will alternate across phases in serving as the &quot;intervention site&quot;&#xD;
      or &quot;control site,&quot; with each agency having a total of two intervention phases and two control&#xD;
      phases.&#xD;
&#xD;
      Intervention Condition: This condition involves a four-session voluntary intervention that is&#xD;
      delivered within a drop-in center setting and is based on the investigator's previous&#xD;
      intervention work with adolescents and young adults. Each session lasts approximately 1 hour.&#xD;
      The intervention focuses on both sexual risk behavior and substance use. Although some&#xD;
      sessions focus more heavily on sexual risk and others on substance use, each session includes&#xD;
      content that emphasizes the interrelated nature of these two risk behaviors. In all sessions,&#xD;
      participants will receive a personalized feedback sheet that specifically addresses a topic&#xD;
      being discussed during that particular session. An motivational interviewing approach will be&#xD;
      used to present material during the group sessions.&#xD;
&#xD;
      &quot;Usual Care&quot; Condition: The &quot;usual care&quot; condition reflects the resources typically available&#xD;
      in settings that serve homeless youth: an HIV informational brochure that discusses the&#xD;
      connection between substance use and HIV risk, and a Community Resource Guide that lists free&#xD;
      or low-cost substance use and HIV-related services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 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>Change in substance use</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in substance use intentions</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in negative consequences from drinking</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in use of drinking protective strategies</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of different sex partners</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in condom use</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in substance use before or during sex</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in HIV knowledge</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sex-related protective strategies</measure>
    <time_frame>baseline, 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sexual intentions</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in HIV testing</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Self-report of being tested in lifetime, past 3 months</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Substance Use</condition>
  <condition>Sexual Risk Behavior</condition>
  <arm_group>
    <arm_group_label>Group MI risk reduction program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive four 1-hour group motivational interviewing sessions focused on reducing substance use and sexual risk behavior. They also receive an HIV information brochure and Community Resource Guide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participant receive HIV information brochure and Community Resource Guide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group MI risk reduction program</intervention_name>
    <arm_group_label>Group MI risk reduction program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18-24 years, receiving services at one of the participating drop-in centers,&#xD;
             planning to be in the study area for the next month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obvious cognitive impairment observed during screening process; non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>My Friend's Place</name>
      <address>
        <city>Hollywood</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Safe Place for Youth</name>
      <address>
        <city>Venice Beach</city>
        <state>California</state>
        <zip>90291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>April 15, 2016</last_update_submitted>
  <last_update_submitted_qc>April 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>homeless</keyword>
  <keyword>young adults</keyword>
  <keyword>substance use</keyword>
  <keyword>HIV risk</keyword>
  <keyword>sexual risk behavior</keyword>
  <keyword>group motivational interviewing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02188797
org study id: R34DA034813
nct id: NCT02188797
lead sponsor: 
has dmc: Yes
The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered
      risk reduction program for homeless young adults. It is hypothesized that youth who
      participate in the program will show greater reductions in substance use intentions, behavior
      and consequences, as well as sexual activity intentions and risk behavior, over a 3-month
      period compared to a usual care control sample of youth who do not participate in the
      program.
This study addresses an important gap in prevention services for homeless youth by conducting
      a pilot test of an innovative 4-session integrated substance use and sexual risk reduction
      program for this population that is feasible to deliver in settings where these youth seek
      services. The study has 2 specific aims:

      Aim 1: Investigate whether homeless youth who participate in the program show reductions in
      substance use and intentions, behavior and consequences, as well as sexual activity
      intentions and risk behavior, over a 3-month period compared to a usual care control sample
      of youth who do not receive the program.

      Aim 2: Gain a better understanding of intervention effects by exploring whether improvements
      in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance
      use and offers serve as explanatory mechanisms for reductions in substance use- and sexual
      activity- related intentions and risk behaviors among youth who participate in the program.

      The program will be evaluated using a form of group-randomized design, although with
      crossover of conditions and groups to avoid the problems of power reduction associated with
      conventional group randomization. The unit of analysis will be the individual, but
      individuals will be assigned to groups based on the agency where they are seeking services.
      Youth at two drop-in centers serving homeless youth will either be in the intervention
      condition or a "usual care" control condition. The field period will be divided into four
      phases. The two agencies will alternate across phases in serving as the "intervention site"
      or "control site," with each agency having a total of two intervention phases and two control
      phases.

      Intervention Condition: This condition involves a four-session voluntary intervention that is
      delivered within a drop-in center setting and is based on the investigator's previous
      intervention work with adolescents and young adults. Each session lasts approximately 1 hour.
      The intervention focuses on both sexual risk behavior and substance use. Although some
      sessions focus more heavily on sexual risk and others on substance use, each session includes
      content that emphasizes the interrelated nature of these two risk behaviors. In all sessions,
      participants will receive a personalized feedback sheet that specifically addresses a topic
      being discussed during that particular session. An motivational interviewing approach will be
      used to present material during the group sessions.

      "Usual Care" Condition: The "usual care" condition reflects the resources typically available
      in settings that serve homeless youth: an HIV informational brochure that discusses the
      connection between substance use and HIV risk, and a Community Resource Guide that lists free
      or low-cost substance use and HIV-related services.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in substance use
time frame: baseline, 3 months
description: past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse
measure: Change in substance use intentions
time frame: baseline, 3 months
description: Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
measure: Change in negative consequences from drinking
time frame: baseline, 3 months
measure: Change in use of drinking protective strategies
time frame: baseline, 3 months
measure: Change in number of different sex partners
time frame: baseline, 3 months
measure: Change in condom use
time frame: baseline, 3 months
measure: Change in substance use before or during sex
time frame: baseline, 3 months
measure: Change in HIV knowledge
time frame: baseline, 3 months
measure: Change in sex-related protective strategies
time frame: baseline, 3 months
measure: Change in sexual intentions
time frame: baseline, 3 months
description: Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested
measure: Change in HIV testing
time frame: baseline, 3 months
description: Self-report of being tested in lifetime, past 3 months
arm group label: Group MI risk reduction program
arm group type: Experimental
description: Participants receive four 1-hour group motivational interviewing sessions focused on reducing substance use and sexual risk behavior. They also receive an HIV information brochure and Community Resource Guide.
arm group label: Usual care control
arm group type: No Intervention
description: Participant receive HIV information brochure and Community Resource Guide.
intervention type: Behavioral
intervention name: Group MI risk reduction program
arm group label: Group MI risk reduction program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders