<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/NCT02982772</url>
  </required_header>
  <id_info>
    <org_study_id>FloridaIU</org_study_id>
    <nct_id>NCT02982772</nct_id>
  </id_info>
  <brief_title>Patch Study - Intervention for HIV Positive Smokers</brief_title>
  <official_title>Biobehavioral Intervention for Smokers Living With HIV (Human Immunodeficiency Virus)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>dr. maria miguez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida International University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and&#xD;
      Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these&#xD;
      excessive levels will enhance the efficacy of the intervention. To test researchers proposed&#xD;
      model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a&#xD;
      double-blind randomized clinical trial intent-to-treat design, comparing a standard&#xD;
      well-validated brief smoking intervention, that following national guidelines + nicotine&#xD;
      replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized&#xD;
      doses of nicotine replacement therapy). The primary outcome for this study will be rates of&#xD;
      smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified&#xD;
      continuous abstinence 3-, 6-, and 12-months post scheduled quit day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and&#xD;
      Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these&#xD;
      excessive levels will enhance the efficacy of the intervention. This will be accomplished by&#xD;
      assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge&#xD;
      has not been used in cessation studies among people living with HIV (PLWH), and 3) providing&#xD;
      tailored feedback to the participants, based on the assumption that the higher the knowledge&#xD;
      and perception of risk, the higher the interest in modifying a risky behavior(s). To test&#xD;
      researchers proposed model based in proven smoking prevention and control methods 600 PLWH&#xD;
      ready to quit smokers will be enrolled in a double-blind randomized clinical trial&#xD;
      intent-to-treat design, comparing a standard well-validated brief smoking intervention, that&#xD;
      following national guidelines will consist on brief advice + nicotine replacement therapy,&#xD;
      versus the tailored one (brief smoking intervention + personalized doses of nicotine&#xD;
      replacement therapy (NRT). The primary outcome for this study will be rates of smoking&#xD;
      cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous&#xD;
      abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the&#xD;
      potential to provide a more complete bio-behavioral model to the intervention field. The&#xD;
      proposed study if successful will provide a new tailored, replicable, and manual-based&#xD;
      intervention for people living with HIV. It can also provide much need it information in&#xD;
      regards to key mediators and moderators of smoking cessation interventions in this vulnerable&#xD;
      population. Researchers long term goal is to reduce the burden of one of the most devastating&#xD;
      causes of morbi-mortality in researchers time and improve their quality of life. The study&#xD;
      could also pave the path to use a similar model to tailor smoking interventions for other&#xD;
      populations (e.g., menthol users, older women, adolescents, older adults).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of Smoking Cessation</measure>
    <time_frame>3 months</time_frame>
    <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of Smoking Cessation</measure>
    <time_frame>6 months</time_frame>
    <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of Smoking Cessation</measure>
    <time_frame>12 months</time_frame>
    <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:&#xD;
CD4 (counts and percentage).&#xD;
HIV Viral load (logs).&#xD;
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).&#xD;
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].&#xD;
In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Verified Continuous Abstinence</measure>
    <time_frame>3 months</time_frame>
    <description>Verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Side Effects-safety</measure>
    <time_frame>Baseline-6 months</time_frame>
    <description>Total number of self reported side effects from Baseline through 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Outcomes</measure>
    <time_frame>12 months</time_frame>
    <description>The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:&#xD;
CD4 (counts and percentage).&#xD;
HIV Viral load (logs).&#xD;
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).&#xD;
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)&#xD;
- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Verified Continuous Abstinence</measure>
    <time_frame>6 months</time_frame>
    <description>verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Verified Continuous Abstinence</measure>
    <time_frame>12 months</time_frame>
    <description>verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Side Effects-safety</measure>
    <time_frame>6 through 12 months</time_frame>
    <description>Total number of self reported side effects from 6 through 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">488</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Tailored Combination Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Doses will be tailored and adjust as need it</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combination Therapy</intervention_name>
    <description>Brief behavioral intervention&#xD;
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
    <arm_group_label>Tailored Combination Therapy</arm_group_label>
    <other_name>Nicoderm, Nicorette</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care Intervention</intervention_name>
    <description>Brief Behavioral Intervention&#xD;
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
    <arm_group_label>Standard Care Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV infected smokers&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  Fluent in English or Spanish&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
          -  Ready to quit smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotic or disabling psychiatric disorders&#xD;
&#xD;
          -  Six months post-myocardial infarction or stroke&#xD;
&#xD;
          -  Diabetes requiring insulin&#xD;
&#xD;
          -  Treatment for vascular problems&#xD;
&#xD;
          -  Non-treated hypertension,&#xD;
&#xD;
          -  Severe liver or kidney disease&#xD;
&#xD;
          -  History of allergies to the nicotine patches&#xD;
&#xD;
          -  Severe eczema or psoriasis&#xD;
&#xD;
          -  Temporal-mandibular joint disease or dental appliances&#xD;
&#xD;
          -  Pregnant women or women that are breastfeeding&#xD;
&#xD;
          -  Subjects participating in other interventions/research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Jose Miguez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida International University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guillermo Castro, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>April 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>July 9, 2021</results_first_submitted>
  <results_first_submitted_qc>August 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2021</results_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Florida International University</investigator_affiliation>
    <investigator_full_name>dr. maria miguez</investigator_full_name>
    <investigator_title>Research Professor</investigator_title>
  </responsible_party>
  <keyword>Nicotine Replacement</keyword>
  <keyword>Smoking</keyword>
  <keyword>HIV</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data will be available only after the study have 2 years of completion. The data to be shared will be de-identified and without data associated with medical records. Access will be provided upon submission of study protocol and if the IRB approves sharing the data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will be available only after two years of study completion</ipd_time_frame>
    <ipd_access_criteria>Requires full disclosure of aims and hypothesis Approval by the center and the IRB committees Signing a limited use agreement</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02982772/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02982772/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02982772/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited with flyers and by referrals.</recruitment_details>
      <pre_assignment_details>488 participants signed consent forms, a total 11 were excluded (6 did not meet smoking criteria, 3 were not compliant, and 2 had pre-existing medical conditions).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tailored Combination Therapy</title>
          <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Standard Care Intervention</title>
          <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrollment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="245"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="245"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="245"/>
                <participants group_id="P2" count="243"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="226"/>
                <participants group_id="P2" count="230"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1M Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="226"/>
                <participants group_id="P2" count="230"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3M Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="205"/>
                <participants group_id="P2" count="212"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="188"/>
                <participants group_id="P2" count="201"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6M Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="188"/>
                <participants group_id="P2" count="201"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="192"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12M Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="192"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
                <participants group_id="P2" count="187"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tailored Combination Therapy</title>
          <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Standard Care Intervention</title>
          <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="245"/>
            <count group_id="B2" value="243"/>
            <count group_id="B3" value="488"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.1" lower_limit="20" upper_limit="69"/>
                    <measurement group_id="B2" value="51.1" lower_limit="21" upper_limit="67"/>
                    <measurement group_id="B3" value="51.1" lower_limit="20" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="245"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rates of Smoking Cessation</title>
        <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
        <time_frame>3 months</time_frame>
        <population>This is the total number of participants in each arm that quit smoking at 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Smoking Cessation</title>
          <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
          <population>This is the total number of participants in each arm that quit smoking at 3 months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rates of Smoking Cessation</title>
        <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
        <time_frame>6 months</time_frame>
        <population>This is the total number of participants in each arm that quit smoking at 6 months. However due to the pandemic we could not verified with biomarkers</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Smoking Cessation</title>
          <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
          <population>This is the total number of participants in each arm that quit smoking at 6 months. However due to the pandemic we could not verified with biomarkers</population>
          <units>Number of pts that quit</units>
          <param>Count of Units</param>
          <units_analyzed>Number of pts that quit</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of pts that quit</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rates of Smoking Cessation</title>
        <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
        <time_frame>12 months</time_frame>
        <population>This is the total number of participants in each arm that quit smoking at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Rates of Smoking Cessation</title>
          <description>verified continuous abstinence (carbon monoxide &lt; 10ppm and cotinine &lt;15 ng/mL).</description>
          <population>This is the total number of participants in each arm that quit smoking at 12 months.</population>
          <units>Number of pts that quit</units>
          <param>Count of Units</param>
          <units_analyzed>Number of pts that quit</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of pts that quit</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Outcomes</title>
        <description>The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:&#xD;
CD4 (counts and percentage).&#xD;
HIV Viral load (logs).&#xD;
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).&#xD;
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].&#xD;
In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</description>
        <time_frame>6 months</time_frame>
        <population>Quality of Life change at 6 months.&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Outcomes</title>
          <description>The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:&#xD;
CD4 (counts and percentage).&#xD;
HIV Viral load (logs).&#xD;
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).&#xD;
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].&#xD;
In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</description>
          <population>Quality of Life change at 6 months.&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</population>
          <units>score on a scale/change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="8.8"/>
                    <measurement group_id="O2" value="0.38" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Verified Continuous Abstinence</title>
        <description>Verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
        <time_frame>3 months</time_frame>
        <population>Verified abstinence at 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Verified Continuous Abstinence</title>
          <description>Verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
          <population>Verified abstinence at 3 months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prevalence of Side Effects-safety</title>
        <description>Total number of self reported side effects from Baseline through 6 months.</description>
        <time_frame>Baseline-6 months</time_frame>
        <population>Total of number of participants in the Tailored &amp; Standard arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Doses will be tailored and adjust as need it&#xD;
Combination Therapy: Brief behavioral intervention&#xD;
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Side Effects-safety</title>
          <description>Total number of self reported side effects from Baseline through 6 months.</description>
          <population>Total of number of participants in the Tailored &amp; Standard arms.</population>
          <units>side effects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="245"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Outcomes</title>
        <description>The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:&#xD;
CD4 (counts and percentage).&#xD;
HIV Viral load (logs).&#xD;
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).&#xD;
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)&#xD;
- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.</description>
        <time_frame>12 months</time_frame>
        <population>Quality of Life change at 12 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Outcomes</title>
          <description>The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:&#xD;
CD4 (counts and percentage).&#xD;
HIV Viral load (logs).&#xD;
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).&#xD;
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].&#xD;
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)&#xD;
- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.</description>
          <population>Quality of Life change at 12 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)</population>
          <units>score on a scale/change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="5.9"/>
                    <measurement group_id="O2" value="0.82" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Verified Continuous Abstinence</title>
        <description>verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
        <time_frame>6 months</time_frame>
        <population>Verified abstinence at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Verified Continuous Abstinence</title>
          <description>verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
          <population>Verified abstinence at 6 months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Verified Continuous Abstinence</title>
        <description>verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
        <time_frame>12 months</time_frame>
        <population>Verified abstinence at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.&#xD;
Combination Therapy: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Verified Continuous Abstinence</title>
          <description>verified continuous abstinence using a breathalyzer carbon monoxide &lt; 10ppm</description>
          <population>Verified abstinence at 12 months.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="187"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prevalence of Side Effects-safety</title>
        <description>Total number of self reported side effects from 6 through 12 months.</description>
        <time_frame>6 through 12 months</time_frame>
        <population>Total of number of participants in the Tailored &amp; Standard arms.</population>
        <group_list>
          <group group_id="O1">
            <title>Tailored Combination Therapy</title>
            <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Doses will be tailored and adjust as need it&#xD;
Combination Therapy: Brief behavioral intervention&#xD;
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Standard Care Intervention</title>
            <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Prevalence of Side Effects-safety</title>
          <description>Total number of self reported side effects from 6 through 12 months.</description>
          <population>Total of number of participants in the Tailored &amp; Standard arms.</population>
          <units>side effects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="245"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tailored Combination Therapy</title>
          <description>Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Doses will be tailored and adjust as need it&#xD;
Combination Therapy: Brief behavioral intervention&#xD;
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Standard Care Intervention</title>
          <description>Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.&#xD;
Standard Flavored gums will be used as needed for 10 weeks.&#xD;
Standard Care Intervention: Brief Behavioral Intervention&#xD;
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.&#xD;
Standard Flavored Gums for 10 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="101" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Jaw Pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Sleepiness</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Body Aches</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decrease Appetite</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Vivid Dreams</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Coughing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Rash</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="243"/>
              </event>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="245"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="243"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Please note that verification of quitting was done in all participants before the pandemic. However, during the pandemic the follow up visits were not in person.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Maria Jose Miguez</name_or_title>
      <organization>Florida International University</organization>
      <phone>561-839-0223</phone>
      <email>mjmiguez@fiu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02982772
org study id: FloridaIU
nct id: NCT02982772
lead sponsor: 
collaborator: 
has dmc: Yes
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and
      Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these
      excessive levels will enhance the efficacy of the intervention. To test researchers proposed
      model 600 people living with HIV (PLWH) ready to quit smokers will be enrolled in a
      double-blind randomized clinical trial intent-to-treat design, comparing a standard
      well-validated brief smoking intervention, that following national guidelines + nicotine
      replacement therapy (NRT), versus the tailored one (brief smoking intervention + personalized
      doses of nicotine replacement therapy). The primary outcome for this study will be rates of
      smoking cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified
      continuous abstinence 3-, 6-, and 12-months post scheduled quit day.
The overall objective of the transdisciplinary team of Human Immunology Virus (HIV) and
      Tobacco funded researchers is to test if tailoring nicotine replacement doses to temper these
      excessive levels will enhance the efficacy of the intervention. This will be accomplished by
      assessing: 1) pre-trial plasma levels, 2) doing genotyping, which to researchers knowledge
      has not been used in cessation studies among people living with HIV (PLWH), and 3) providing
      tailored feedback to the participants, based on the assumption that the higher the knowledge
      and perception of risk, the higher the interest in modifying a risky behavior(s). To test
      researchers proposed model based in proven smoking prevention and control methods 600 PLWH
      ready to quit smokers will be enrolled in a double-blind randomized clinical trial
      intent-to-treat design, comparing a standard well-validated brief smoking intervention, that
      following national guidelines will consist on brief advice + nicotine replacement therapy,
      versus the tailored one (brief smoking intervention + personalized doses of nicotine
      replacement therapy (NRT). The primary outcome for this study will be rates of smoking
      cessation, point prevalence abstinence (prior 7 and prior 30 days), and verified continuous
      abstinence 3-, 6-, and 12-months post scheduled quit day. The knowledge gained here has the
      potential to provide a more complete bio-behavioral model to the intervention field. The
      proposed study if successful will provide a new tailored, replicable, and manual-based
      intervention for people living with HIV. It can also provide much need it information in
      regards to key mediators and moderators of smoking cessation interventions in this vulnerable
      population. Researchers long term goal is to reduce the burden of one of the most devastating
      causes of morbi-mortality in researchers time and improve their quality of life. The study
      could also pave the path to use a similar model to tailor smoking interventions for other
      populations (e.g., menthol users, older women, adolescents, older adults).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Rates of Smoking Cessation
time frame: 3 months
description: verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
measure: Rates of Smoking Cessation
time frame: 6 months
description: verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
measure: Rates of Smoking Cessation
time frame: 12 months
description: verified continuous abstinence (carbon monoxide < 10ppm and cotinine <15 ng/mL).
measure: Change in Clinical Outcomes
time frame: 6 months
description: The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
CD4 (counts and percentage).
HIV Viral load (logs).
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].
In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
measure: Number of Participants With Verified Continuous Abstinence
time frame: 3 months
description: Verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm
measure: Prevalence of Side Effects-safety
time frame: Baseline-6 months
description: Total number of self reported side effects from Baseline through 6 months.
measure: Change in Clinical Outcomes
time frame: 12 months
description: The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves:
CD4 (counts and percentage).
HIV Viral load (logs).
Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute).
Anthropometric measures [Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches].
Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.
measure: Number of Participants With Verified Continuous Abstinence
time frame: 6 months
description: verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm
measure: Number of Participants With Verified Continuous Abstinence
time frame: 12 months
description: verified continuous abstinence using a breathalyzer carbon monoxide < 10ppm
measure: Prevalence of Side Effects-safety
time frame: 6 through 12 months
description: Total number of self reported side effects from 6 through 12 months.
arm group label: Tailored Combination Therapy
arm group type: Experimental
description: Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.
Doses will be tailored and adjust as need it
arm group label: Standard Care Intervention
arm group type: Active Comparator
description: Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
intervention type: Other
intervention name: Combination Therapy
description: Brief behavioral intervention
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
arm group label: Tailored Combination Therapy
other name: Nicoderm, Nicorette
intervention type: Other
intervention name: Standard Care Intervention
description: Brief Behavioral Intervention
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
arm group label: Standard Care Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Jose Miguez, MD
role: Principal Investigator
affiliation: Florida International University
last name: Guillermo Castro, MD
role: Study Director
affiliation: University of Miami
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Florida International University
investigator full name: dr. maria miguez
investigator title: Research Professor
mesh term: Nicotine
sharing ipd: Yes
ipd description: The data will be available only after the study have 2 years of completion. The data to be shared will be de-identified and without data associated with medical records. Access will be provided upon submission of study protocol and if the IRB approves sharing the data.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will be available only after two years of study completion
ipd access criteria: Requires full disclosure of aims and hypothesis Approval by the center and the IRB committees Signing a limited use agreement
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Please note that verification of quitting was done in all participants before the pandemic. However, during the pandemic the follow up visits were not in person.
point of contact: 