<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/NCT03808714</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-160204003</org_study_id>
    <nct_id>NCT03808714</nct_id>
  </id_info>
  <brief_title>Smoking Cessation Tailored to Rural Young Adult African American Men:</brief_title>
  <official_title>Development, Implementation, and Evaluation of a Smoking Cessation Tailored to Rural Young Adult African American Men: Toward Scalability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      Our preliminary data shows that 39.9% of AA men between 19 and 30 years of age who resided in&#xD;
      rural Alabama smoke cigarettes. Although it has been well established that a combination of&#xD;
      pharmacotherapy and advice-oriented counseling and/or cognitive behavioral interventions are&#xD;
      efficacious in promoting smoking cessation across diverse populations, these evidence-based&#xD;
      treatments for tobacco dependence have not proven to be effective/efficacious (or even&#xD;
      accessible) among some subpopulations suffering disproportionally from tobacco-related&#xD;
      morbidity and mortality. The overall goal of this feasibility study is to make adaptations to&#xD;
      these evidence-based approaches, and develop, implement, and examine the feasibility and&#xD;
      scalability of a theory-based, culturally relevant smoking cessation intervention for young&#xD;
      adult AA men in rural Alabama who smoke cigarettes. Our formative assessments point to a&#xD;
      cognitive-behavioral intervention delivered by a trained Community Health Worker with the&#xD;
      support from an &quot;expert&quot; physician who can deliver the pharmacological component via Skype&#xD;
      through an integrated approach. The proposed study will address the next three steps in this&#xD;
      process: development of the intervention, pretesting, and feasibility. First, we will develop&#xD;
      the intervention with input from a Community Advisory Committee, followed by an iterative&#xD;
      process by which the target audience will be exposed to materials and messages to provide&#xD;
      feedback (pretesting). Once all intervention components are finalized, we will recruit&#xD;
      participants, randomly assign them to intervention/control groups, pilot test, and evaluate&#xD;
      the intervention. The comparison group will be the Alabama Tobacco Quitline with 8 weeks of&#xD;
      Nicotine Replacement Therapy to be consistent with the pharmacological approach proposed for&#xD;
      the intervention. The primary outcome will be 7-day point prevalence abstinence (defined as&#xD;
      no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide&#xD;
      levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and&#xD;
      scalability assessments (acceptability, feasibility, potential reach and adoption, alignment&#xD;
      with the strategic context) to inform a full-scale efficacy trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite smoking fewer cigarettes daily, African American (AA) men suffer higher morbidity and&#xD;
      mortality associated with tobacco-related disorders than whites. Our preliminary data shows&#xD;
      that 39.9% of AA men between 19 and 30 years of age who resided in rural Alabama smoke&#xD;
      cigarettes. Although it has been well established that a combination of pharmacotherapy and&#xD;
      advice-oriented counseling and/or cognitive behavioral interventions are efficacious in&#xD;
      promoting smoking cessation across diverse populations, these evidence-based treatments for&#xD;
      tobacco dependence have not proven to be effective/efficacious (or even accessible) among&#xD;
      some subpopulations suffering disproportionally from tobacco-related morbidity and mortality.&#xD;
      The overall goal of this feasibility study is to make adaptations to these evidence-based&#xD;
      approaches, and develop, implement, and examine the feasibility and scalability of a&#xD;
      theory-based, culturally relevant smoking cessation intervention for young adult AA men in&#xD;
      rural Alabama who smoke cigarettes. Our formative assessments point to a cognitive-behavioral&#xD;
      intervention delivered by a trained Community Health Worker with the support from an &quot;expert&quot;&#xD;
      physician who can deliver the pharmacological component via Skype through an integrated&#xD;
      approach. The proposed study will address the next three steps in this process: development&#xD;
      of the intervention, pretesting, and feasibility. First, we will develop the intervention&#xD;
      with input from a Community Advisory Committee, followed by an iterative process by which the&#xD;
      target audience will be exposed to materials and messages to provide feedback (pretesting).&#xD;
      Once all intervention components are finalized, we will recruit participants, randomly assign&#xD;
      them to intervention/control groups, pilot test, and evaluate the intervention. The&#xD;
      comparison group will be the Alabama Tobacco Quitline with 8 weeks of Nicotine Replacement&#xD;
      Therapy to be consistent with the pharmacological approach proposed for the intervention. The&#xD;
      primary outcome will be 7-day point prevalence abstinence (defined as no cigarettes in the&#xD;
      past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month&#xD;
      follow-up. We will also conduct detailed treatment fidelity and scalability assessments&#xD;
      (acceptability, feasibility, potential reach and adoption, alignment with the strategic&#xD;
      context) to inform a full-scale efficacy trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulties in recruitment due to COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">April 26, 2016</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention - smoking cessation program delivered by Community Health Worker with pharmacological support by a specialist at the university Control - Alabama Quitline</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cessation</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome will be a 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month follow-up.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We expect the intervention to consist of 3 to 4 group sessions and at least one individual session (delivered by a trained Community Health Worker) plus pharmacological consultation(s) via telemedicine, but this will be determined during pretesting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Alabama Tobacco Quitline, which is considered the &quot;standard-of-care&quot; for smoking cessation in Alabama.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TOUCHDOWN</intervention_name>
    <description>We expect the intervention to consist of 3 to 4 group sessions and at least one individual session plus pharmacological consultation(s) via Skype, but this will be determined during pretesting. CHWs will have IPads with cellular connectivity and will be present when the pharmacological approach is discussed with the participant so that they can reinforce the message with the participant and be the liaisons between the participant and physician.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Alabama Quitline</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (a) African American; (b) men; (c) between the ages of 18 and 30; (d) residing in Sumter&#xD;
        and Greene counties; and (e) smoked cigarettes within the past seven days. For the&#xD;
        feasibility testing of the intervention, participants must have a permanent residence in&#xD;
        the county and no intent to move within the next 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent MI and unstable angina.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>African American men between the ages of 18 and 30 living in the participating rural counties</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabel C Scarinci, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Carroll, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Isabel Scarinci</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>african american, smoking cessation, rural, young adults</keyword>
  <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/NCT03808714
org study id: IRB-160204003
nct id: NCT03808714
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our preliminary data shows that 39.9% of AA men between 19 and 30 years of age who resided in
      rural Alabama smoke cigarettes. Although it has been well established that a combination of
      pharmacotherapy and advice-oriented counseling and/or cognitive behavioral interventions are
      efficacious in promoting smoking cessation across diverse populations, these evidence-based
      treatments for tobacco dependence have not proven to be effective/efficacious (or even
      accessible) among some subpopulations suffering disproportionally from tobacco-related
      morbidity and mortality. The overall goal of this feasibility study is to make adaptations to
      these evidence-based approaches, and develop, implement, and examine the feasibility and
      scalability of a theory-based, culturally relevant smoking cessation intervention for young
      adult AA men in rural Alabama who smoke cigarettes. Our formative assessments point to a
      cognitive-behavioral intervention delivered by a trained Community Health Worker with the
      support from an "expert" physician who can deliver the pharmacological component via Skype
      through an integrated approach. The proposed study will address the next three steps in this
      process: development of the intervention, pretesting, and feasibility. First, we will develop
      the intervention with input from a Community Advisory Committee, followed by an iterative
      process by which the target audience will be exposed to materials and messages to provide
      feedback (pretesting). Once all intervention components are finalized, we will recruit
      participants, randomly assign them to intervention/control groups, pilot test, and evaluate
      the intervention. The comparison group will be the Alabama Tobacco Quitline with 8 weeks of
      Nicotine Replacement Therapy to be consistent with the pharmacological approach proposed for
      the intervention. The primary outcome will be 7-day point prevalence abstinence (defined as
      no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide
      levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and
      scalability assessments (acceptability, feasibility, potential reach and adoption, alignment
      with the strategic context) to inform a full-scale efficacy trial.
Despite smoking fewer cigarettes daily, African American (AA) men suffer higher morbidity and
      mortality associated with tobacco-related disorders than whites. Our preliminary data shows
      that 39.9% of AA men between 19 and 30 years of age who resided in rural Alabama smoke
      cigarettes. Although it has been well established that a combination of pharmacotherapy and
      advice-oriented counseling and/or cognitive behavioral interventions are efficacious in
      promoting smoking cessation across diverse populations, these evidence-based treatments for
      tobacco dependence have not proven to be effective/efficacious (or even accessible) among
      some subpopulations suffering disproportionally from tobacco-related morbidity and mortality.
      The overall goal of this feasibility study is to make adaptations to these evidence-based
      approaches, and develop, implement, and examine the feasibility and scalability of a
      theory-based, culturally relevant smoking cessation intervention for young adult AA men in
      rural Alabama who smoke cigarettes. Our formative assessments point to a cognitive-behavioral
      intervention delivered by a trained Community Health Worker with the support from an "expert"
      physician who can deliver the pharmacological component via Skype through an integrated
      approach. The proposed study will address the next three steps in this process: development
      of the intervention, pretesting, and feasibility. First, we will develop the intervention
      with input from a Community Advisory Committee, followed by an iterative process by which the
      target audience will be exposed to materials and messages to provide feedback (pretesting).
      Once all intervention components are finalized, we will recruit participants, randomly assign
      them to intervention/control groups, pilot test, and evaluate the intervention. The
      comparison group will be the Alabama Tobacco Quitline with 8 weeks of Nicotine Replacement
      Therapy to be consistent with the pharmacological approach proposed for the intervention. The
      primary outcome will be 7-day point prevalence abstinence (defined as no cigarettes in the
      past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month
      follow-up. We will also conduct detailed treatment fidelity and scalability assessments
      (acceptability, feasibility, potential reach and adoption, alignment with the strategic
      context) to inform a full-scale efficacy trial.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Intervention - smoking cessation program delivered by Community Health Worker with pharmacological support by a specialist at the university Control - Alabama Quitline
primary purpose: Prevention
masking: None (Open Label)
measure: Cessation
time frame: 6 months
description: The primary outcome will be a 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month follow-up.
arm group label: Intervention
arm group type: Active Comparator
description: We expect the intervention to consist of 3 to 4 group sessions and at least one individual session (delivered by a trained Community Health Worker) plus pharmacological consultation(s) via telemedicine, but this will be determined during pretesting.
arm group label: Control
arm group type: Active Comparator
description: Alabama Tobacco Quitline, which is considered the "standard-of-care" for smoking cessation in Alabama.
intervention type: Behavioral
intervention name: TOUCHDOWN
description: We expect the intervention to consist of 3 to 4 group sessions and at least one individual session plus pharmacological consultation(s) via Skype, but this will be determined during pretesting. CHWs will have IPads with cellular connectivity and will be present when the pharmacological approach is discussed with the participant so that they can reinforce the message with the participant and be the liaisons between the participant and physician.
arm group label: Intervention
intervention type: Behavioral
intervention name: Control Group
description: Alabama Quitline
arm group label: Control
criteria: 
gender: Male
gender based: Yes
gender description: African American men between the ages of 18 and 30 living in the participating rural counties
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Isabel C Scarinci, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: William Carroll, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Isabel Scarinci
investigator title: Primary Investigator
sharing ipd: No