<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/NCT04505371</url>
  </required_header>
  <id_info>
    <org_study_id>1R01CA243907-01</org_study_id>
    <nct_id>NCT04505371</nct_id>
  </id_info>
  <brief_title>Improving the Reach &amp; Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV</brief_title>
  <acronym>WISH</acronym>
  <official_title>Improving the Reach and Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Institute for Biomedical and Clinical Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Institute for Biomedical and Clinical Research</source>
  <oversight_info>
    <has_dmc>Yes</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 project will compare the effectiveness of an HIV-specific comprehensive wellness&#xD;
      intervention designed to have broad appeal to smokers living with HIV to the effectiveness of&#xD;
      standard care services that include referral to the National VA Quitline and SmokefreeVET&#xD;
      texting program. Participants in both arms will have access to pharmacotherapy available&#xD;
      through their Veterans Affairs (VA) healthcare providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tobacco use remains the leading preventable cause of death and illness in our society, and&#xD;
      smoking rates are disproportionately high among people living with HIV. NCI, nicotine&#xD;
      dependence researchers, and HIV clinicians have all called for research to evaluate targeted&#xD;
      and tailored smoking cessation programs for smokers living with HIV (SLWH). Research suggests&#xD;
      SLWH are largely unaware of the HIV-specific deleterious effects of smoking and often lack&#xD;
      motivation and confidence in their ability to quit. For these reasons, we developed the&#xD;
      Wellness Intervention for Smokers with HIV (WISH).&#xD;
&#xD;
      Similar to standard care cessation services available to Veterans, WISH is delivered remotely&#xD;
      by mobile phone (voice and text message). The program is designed for all SLWH, regardless of&#xD;
      their initial motivation to quit. WISH follows evidence-based, best practice guidelines for&#xD;
      nicotine dependence treatment, but is innovative in its use of a more comprehensive wellness&#xD;
      approach. That is, the intervention addresses both smoking and a number of other personally&#xD;
      relevant health behaviors (such as treatment engagement, medication adherence, stress and&#xD;
      mood management, social support, alcohol use, etc.), making it relevant and engaging to all&#xD;
      SLWH, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed&#xD;
      to build and strengthen motivation and self-confidence for quitting, while smokers also work&#xD;
      on other personal health goals.&#xD;
&#xD;
      Once ready to quit smoking, participants receive evidence-based cognitive-behavioral&#xD;
      counseling and encouragement to access nicotine replacement therapy (NRT) or other&#xD;
      appropriate pharmacotherapy through usual care VA procedures. Medications will not be&#xD;
      prescribed or dispensed by the study, allowing use of these standard services to be compared&#xD;
      across study groups.&#xD;
&#xD;
      In this two-group randomized trial, we will compare the effectiveness of WISH to standard&#xD;
      care services offered through the National VA Quitline and the SmokefreeVET texting program&#xD;
      (tobacco cessation services available to all Veterans). Participants in both study groups can&#xD;
      receive phone/ text counseling and have access to pharmacotherapy through VA. Cessation&#xD;
      services in both study groups will be provided and overseen by the non-VA sites that&#xD;
      developed each program.&#xD;
&#xD;
      Smoking-related outcomes will include 7-day point prevalence smoking abstinence and presence&#xD;
      of any 24-hour intentional quit attempts, prolonged abstinence, and change in cigarettes per&#xD;
      day. We will measure change in smoking-related knowledge, motivation and behavioral skills,&#xD;
      as well as intervention reach and implementation. We will also describe comorbidities and&#xD;
      explore intervention impact on markers of immune status and mortality risk using clinical&#xD;
      data resources available through the Veterans Aging Cohort Study (VACS).&#xD;
&#xD;
      If effective, WISH could meaningfully increase the reach of cessation services and reduce&#xD;
      smoking among HIV+ Veterans nationwide. To support this goal, dissemination efforts are&#xD;
      planned in Year 5 to share the WISH program with the National VA Quitline. Because VA is the&#xD;
      largest U.S. provider of HIV care, this research has the potential for significant public&#xD;
      health impact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 4, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-day point-prevalence abstinence (PPA)</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Smoking abstinence at 6-month follow-up by self-report and biochemically confirmed via saliva cotinine for a small selected group of individuals. Cotinine levels &lt; 10 ng/ml and a self-report of 7 day PPA will be required to be coded a nonsmoker.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any 24-hour intentional quit attempt</measure>
    <time_frame>3 and 6 months postrandomization</time_frame>
    <description>The primary outcome will be presence of an intentional quit attempt [yes/no] reported between randomization and 6 month follow-up. Quit attempts will be assessed at each follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Floating prolonged abstinence</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>A proxy for sustained abstinence appropriate for evaluating a motivational intervention, in which the start point floats based on one's actual quit date rather than a pre-determined quit date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>7-day self-report point-prevalence abstinence (PPA)</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>Self-report of abstinence from smoking, even a puff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day self-report point-prevalence abstinence (PPA)</measure>
    <time_frame>3, 6, 12 months post-randomization</time_frame>
    <description>Self-report of abstinence from smoking, even a puff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarettes smoked per day</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>Self-report; even a puff counts as smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV-specific smoking knowledge</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>Items validated in a survey of Smokers Living with HIV conducted by the study team during a study titled &quot;Smoking cessation-related information, motivation, and behavioral skills specific to HIV-infected smokers&quot; (likert scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation to quit smoking</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>1-10 likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking cessation related to self-efficacy</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nicotine withdrawal symptom management (behavioral skills)</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>Self-report Minnesota Smoking Withdrawal Scale, Revised</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cessation medication use and adherence (behavioral skills)</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>Self-report and health records (pharmacy) monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute CD4 count</measure>
    <time_frame>6 and 12 months post-randomization</time_frame>
    <description>Lab value of CD4 ascertained via EHR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VACS index 2.0</measure>
    <time_frame>6 and 12 months post-randomization</time_frame>
    <description>Composite score based of various lab values ascertained via EHR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intentional quit attempt frequency and duration</measure>
    <time_frame>3 and 6 months post-randomization</time_frame>
    <description>Behavioral Risk Factor Surveillance System (BRFSS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>HIV Infections</condition>
  <condition>Smoking</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Control - Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention - Wellness Intervention for Smokers with HIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Intervention for Smokers with HIV</intervention_name>
    <description>WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.&#xD;
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.</description>
    <arm_group_label>Intervention - Wellness Intervention for Smokers with HIV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In care in the VA&#xD;
&#xD;
          -  HIV+ serostatus&#xD;
&#xD;
          -  Currently smoking 5+ cigarettes daily&#xD;
&#xD;
          -  Access to cell phone with text messaging capabilities&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychosis, dementia or significant cognitive impairment documented in the EHR&#xD;
&#xD;
          -  Documented or observed hearing or comprehension difficulties that would preclude&#xD;
             participation in study telephone calls&#xD;
&#xD;
          -  Currently receiving cessation counseling or using an FDA approved treatment to quit&#xD;
             smoking&#xD;
&#xD;
          -  Institutionalized/imprisoned&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristina Crothers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound Health Care System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John Kundzins, BS</last_name>
    <phone>(206) 268-5278</phone>
    <email>John.Kundzins@VA.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristina Crothers, MD</last_name>
    <phone>(206) 277-3013</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System Seattle Division</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Kundzins, BS</last_name>
      <phone>206-768-5278</phone>
      <email>John.Kundzins@va.gov</email>
    </contact>
    <investigator>
      <last_name>Kristina A Crothers, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Smoking</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Remote Intervention</keyword>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Veterans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04505371
org study id: 1R01CA243907-01
nct id: NCT04505371
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project will compare the effectiveness of an HIV-specific comprehensive wellness
      intervention designed to have broad appeal to smokers living with HIV to the effectiveness of
      standard care services that include referral to the National VA Quitline and SmokefreeVET
      texting program. Participants in both arms will have access to pharmacotherapy available
      through their Veterans Affairs (VA) healthcare providers.
Tobacco use remains the leading preventable cause of death and illness in our society, and
      smoking rates are disproportionately high among people living with HIV. NCI, nicotine
      dependence researchers, and HIV clinicians have all called for research to evaluate targeted
      and tailored smoking cessation programs for smokers living with HIV (SLWH). Research suggests
      SLWH are largely unaware of the HIV-specific deleterious effects of smoking and often lack
      motivation and confidence in their ability to quit. For these reasons, we developed the
      Wellness Intervention for Smokers with HIV (WISH).

      Similar to standard care cessation services available to Veterans, WISH is delivered remotely
      by mobile phone (voice and text message). The program is designed for all SLWH, regardless of
      their initial motivation to quit. WISH follows evidence-based, best practice guidelines for
      nicotine dependence treatment, but is innovative in its use of a more comprehensive wellness
      approach. That is, the intervention addresses both smoking and a number of other personally
      relevant health behaviors (such as treatment engagement, medication adherence, stress and
      mood management, social support, alcohol use, etc.), making it relevant and engaging to all
      SLWH, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed
      to build and strengthen motivation and self-confidence for quitting, while smokers also work
      on other personal health goals.

      Once ready to quit smoking, participants receive evidence-based cognitive-behavioral
      counseling and encouragement to access nicotine replacement therapy (NRT) or other
      appropriate pharmacotherapy through usual care VA procedures. Medications will not be
      prescribed or dispensed by the study, allowing use of these standard services to be compared
      across study groups.

      In this two-group randomized trial, we will compare the effectiveness of WISH to standard
      care services offered through the National VA Quitline and the SmokefreeVET texting program
      (tobacco cessation services available to all Veterans). Participants in both study groups can
      receive phone/ text counseling and have access to pharmacotherapy through VA. Cessation
      services in both study groups will be provided and overseen by the non-VA sites that
      developed each program.

      Smoking-related outcomes will include 7-day point prevalence smoking abstinence and presence
      of any 24-hour intentional quit attempts, prolonged abstinence, and change in cigarettes per
      day. We will measure change in smoking-related knowledge, motivation and behavioral skills,
      as well as intervention reach and implementation. We will also describe comorbidities and
      explore intervention impact on markers of immune status and mortality risk using clinical
      data resources available through the Veterans Aging Cohort Study (VACS).

      If effective, WISH could meaningfully increase the reach of cessation services and reduce
      smoking among HIV+ Veterans nationwide. To support this goal, dissemination efforts are
      planned in Year 5 to share the WISH program with the National VA Quitline. Because VA is the
      largest U.S. provider of HIV care, this research has the potential for significant public
      health impact.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: 7-day point-prevalence abstinence (PPA)
time frame: 6 months post-randomization
description: Smoking abstinence at 6-month follow-up by self-report and biochemically confirmed via saliva cotinine for a small selected group of individuals. Cotinine levels < 10 ng/ml and a self-report of 7 day PPA will be required to be coded a nonsmoker.
measure: Any 24-hour intentional quit attempt
time frame: 3 and 6 months postrandomization
description: The primary outcome will be presence of an intentional quit attempt [yes/no] reported between randomization and 6 month follow-up. Quit attempts will be assessed at each follow-up.
measure: Floating prolonged abstinence
time frame: 3 and 6 months post-randomization
description: A proxy for sustained abstinence appropriate for evaluating a motivational intervention, in which the start point floats based on one's actual quit date rather than a pre-determined quit date
measure: 7-day self-report point-prevalence abstinence (PPA)
time frame: 3 and 6 months post-randomization
description: Self-report of abstinence from smoking, even a puff
measure: 30-day self-report point-prevalence abstinence (PPA)
time frame: 3, 6, 12 months post-randomization
description: Self-report of abstinence from smoking, even a puff
measure: Cigarettes smoked per day
time frame: 3 and 6 months post-randomization
description: Self-report; even a puff counts as smoking
measure: HIV-specific smoking knowledge
time frame: 3 and 6 months post-randomization
description: Items validated in a survey of Smokers Living with HIV conducted by the study team during a study titled "Smoking cessation-related information, motivation, and behavioral skills specific to HIV-infected smokers" (likert scale)
measure: Motivation to quit smoking
time frame: 3 and 6 months post-randomization
description: 1-10 likert scale
measure: Smoking cessation related to self-efficacy
time frame: 3 and 6 months post-randomization
description: 1-10 likert scale on domains (each) of quitting smoking, reducing smoking, managing cravings, and stimulus control
measure: Nicotine withdrawal symptom management (behavioral skills)
time frame: 3 and 6 months post-randomization
description: Self-report Minnesota Smoking Withdrawal Scale, Revised
measure: Cessation medication use and adherence (behavioral skills)
time frame: 3 and 6 months post-randomization
description: Self-report and health records (pharmacy) monitoring
measure: Absolute CD4 count
time frame: 6 and 12 months post-randomization
description: Lab value of CD4 ascertained via EHR
measure: VACS index 2.0
time frame: 6 and 12 months post-randomization
description: Composite score based of various lab values ascertained via EHR
measure: Intentional quit attempt frequency and duration
time frame: 3 and 6 months post-randomization
description: Behavioral Risk Factor Surveillance System (BRFSS)
arm group label: Control - Standard Care
arm group type: No Intervention
description: The control intervention is referral to standard evidence-based cessation services available nationally to Veterans, including the National VA Quitline and SmokefreeVET texting program.
arm group label: Intervention - Wellness Intervention for Smokers with HIV
arm group type: Experimental
description: The experimental WISH intervention is an HIV-specific comprehensive wellness program designed to offer integrated phone and text counseling regardless of readiness to quit.
intervention type: Behavioral
intervention name: Wellness Intervention for Smokers with HIV
description: WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study.
arm group label: Intervention - Wellness Intervention for Smokers with HIV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristina Crothers, MD
role: Principal Investigator
affiliation: VA Puget Sound Health Care System
last name: John Kundzins, BS
phone: (206) 268-5278
email: John.Kundzins@VA.gov
last name: Kristina Crothers, MD
phone: (206) 277-3013
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: Undecided