<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/NCT02190643</url>
  </required_header>
  <id_info>
    <org_study_id>R21DA035629</org_study_id>
    <nct_id>NCT02190643</nct_id>
  </id_info>
  <brief_title>Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers</brief_title>
  <official_title>Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive&#xD;
      smokers focused on improving adherence to using the nicotine skin patch.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Continuous abstinence</measure>
    <time_frame>3 months post-quit date</time_frame>
    <description>No smoking from the target quit date through the 3-month follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>biochemically-verified 7-day point prevalence abstinence</measure>
    <time_frame>3 months post-quit date</time_frame>
    <description>No smoking in the 7 prior days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nicotine patch adherence</measure>
    <time_frame>3 months post-quit date</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Adherence condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cessation counseling with adherence focus</intervention_name>
    <arm_group_label>Adherence condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cessation counseling without adherence focus</intervention_name>
    <arm_group_label>Standard condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Latino&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  current, daily smoker&#xD;
&#xD;
          -  ready to set quit date in next 30 days&#xD;
&#xD;
          -  willing to try the nicotine patch&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suffering from any medical condition which would prevent using the nicotine patch&#xD;
&#xD;
          -  currently using other tobacco products or e-cigarettes&#xD;
&#xD;
          -  currently receiving counseling or medication to quit or reduce smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bienestar Human Services Inc</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</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 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 5, 2016</last_update_submitted>
  <last_update_submitted_qc>April 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>HIV</keyword>
  <keyword>Latino</keyword>
  <keyword>Cessation</keyword>
  <keyword>Nicotine patch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Seropositivity</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/NCT02190643
org study id: R21DA035629
nct id: NCT02190643
lead sponsor: 
has dmc: No
The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive
      smokers focused on improving adherence to using the nicotine skin patch.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Continuous abstinence
time frame: 3 months post-quit date
description: No smoking from the target quit date through the 3-month follow-up
measure: biochemically-verified 7-day point prevalence abstinence
time frame: 3 months post-quit date
description: No smoking in the 7 prior days
measure: Nicotine patch adherence
time frame: 3 months post-quit date
arm group label: Adherence condition
arm group type: Experimental
description: Brief smoking cessation counseling session (based on 5 A's approach) that includes a module focused on improving adherence to using the nicotine patch, plus 8-week supply of nicotine patches.
arm group label: Standard condition
arm group type: Active Comparator
description: Brief smoking cessation counseling session (based on 5 A's approach) that does not include a module focused on improving nicotine patch adherence, plus 8-week supply of nicotine patches.
intervention type: Behavioral
intervention name: Cessation counseling with adherence focus
arm group label: Adherence condition
intervention type: Behavioral
intervention name: Cessation counseling without adherence focus
arm group label: Standard condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: HIV Seropositivity