<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/NCT03289676</url>
  </required_header>
  <id_info>
    <org_study_id>2017147</org_study_id>
    <nct_id>NCT03289676</nct_id>
  </id_info>
  <brief_title>Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV</brief_title>
  <acronym>WISE</acronym>
  <official_title>Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Boston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Boston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      HIV has transformed into a chronic illness due to the advent of effective treatments in the&#xD;
      absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs),&#xD;
      including lung cancer, has increased three-fold among people living with HIV. NADCs now&#xD;
      account for 50% of all cancers among the people. Smoking is one of the major contributing&#xD;
      factors to lung cancer and smoking prevalence is substantially higher in this population than&#xD;
      the general U.S. population. Smoking prevalence does not differ by gender among people living&#xD;
      with HIV. Women of color, particularly African American women represent the majority of women&#xD;
      living with HIV (WLHIV) followed by Latinas. WLHIV smoke at a rate almost 3 times higher than&#xD;
      that for the general U.S. female population (e.g., 42% vs. 16%). The proposed study has two&#xD;
      phases: 1) the development of a storytelling narrative communication (SNC) intervention that&#xD;
      will be added to an established HIV-tailored smoking cessation intervention and 2) a two-arm&#xD;
      randomized controlled trial (RCT) of the HIV-tailored intervention plus the SNC Intervention&#xD;
      compared with the HIV-tailored intervention only. The investigators will develop narrative&#xD;
      videos with three to five WLHIV who will be talking about their personal struggles with&#xD;
      smoking and success in quitting. Preliminary study revealed that the established HIV-tailored&#xD;
      intervention was effective only for short-term (≤ 2 months) abstinence. Many relapsed to&#xD;
      smoking between the 2nd and 6th month of quitting. The investigators propose that the SNC&#xD;
      intervention will be an effective strategy to sustain their quit efforts for long-term&#xD;
      abstinence (≥ 6 months). A total of 60 WLHIV will be recruited and randomly assigned to&#xD;
      either the experimental arm (a combination of HIV-tailored and SNC interventions) or the&#xD;
      control arm (HIV-tailored intervention only). Specific aims of the study are to 1) Identify&#xD;
      SNC intervention components that are rated high in transport and identification for use as an&#xD;
      enhancement to an HIV-tailored smoking cessation intervention; 2) Determine the feasibility&#xD;
      and acceptability of the SNC intervention for WLHIV by assessing the rate of recruitment and&#xD;
      retention for feasibility and the degree of transport and identification for acceptability;&#xD;
      and 3) Establish an effect size of HIV-tailored and SNC interventions for smoking cessation&#xD;
      in comparison with the HIV-tailored smoking cessation intervention only for WLHIV, for&#xD;
      subsequent grant applications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study employs a mixed-methods research design. The investigators will first&#xD;
      develop narrative videos in collaboration with community organizations of WLHIV in Boston.&#xD;
      Second, the investigators will conduct a two-arm RCT assigning participants at a ratio of 1:1&#xD;
      to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control:&#xD;
      HIV-tailored intervention). Both arms have eight weekly sessions of a 30-minute HIV-tailored&#xD;
      cessation intervention (cognitive behavioral therapy plus nicotine patches). The experimental&#xD;
      arm will receive three 5-7 minute SNC videos, each per month between the first and third&#xD;
      month of quitting, whereas the control arm will receive three 5-minute attention control&#xD;
      videos at the same monthly interval.&#xD;
&#xD;
      A total of 60 WLHIV will be recruited via online and offline advertisements and personal&#xD;
      networks of community organizations and health care providers who work for people with HIV.&#xD;
      To participate in the study, the following criteria must be met: women who 1) are able to&#xD;
      speak English; 2) self-report HIV infection and submit a supplementary document if necessary;&#xD;
      3) are between the ages of 18 and 65; 4) have been smoking at least 5 cigarettes a day for&#xD;
      the past 6 months; 5) own a mobile phone with an access to a video call application such as&#xD;
      Skype, Imo, Tango, and Face Time; 6) are willing to quit smoking within the next 4 weeks from&#xD;
      the baseline assessment; and 7) agree to use an approved form of birth control (e.g., oral&#xD;
      medications, condoms, and intrauterine devices) during the study period. Individuals will be&#xD;
      excluded if they: 1) are not able to speak English; 2) are pregnant or lactating; 3) have an&#xD;
      active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders&#xD;
      Identification Test), 4) self-report currently receiving treatment for a serious mental&#xD;
      illness (e.g., schizophrenia and bipolar disorder); or 5) currently use any illegal&#xD;
      substances excluding marijuana.&#xD;
&#xD;
      The investigators will recruit participants with frequent announcements of the study in&#xD;
      Craigslist and paid online advertisements. The majority of intake interviews will be&#xD;
      conducted via telephone, which will take 30 minutes at most. To prevent attrition, the&#xD;
      investigators will execute several strategies, including tracking subjects at least every&#xD;
      other month and providing incentives for follow-up testing. Counselors will proactively call&#xD;
      participants prior to each therapy session and confirm the appointment a few hours before the&#xD;
      session. A research assistant (RA) who will be blinded to the intervention condition will&#xD;
      conduct all follow-up assessments via telephone calls and videoconferencing for saliva&#xD;
      cotinine tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2018</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>: The proposed study has two phases.&#xD;
Phase 1. Development of Narrative Video: We will first develop narrative videos in collaboration with community organizations of WLHIV in Boston. The video will be filmed in person at the University of Massachusetts Boston.&#xD;
Phase 2. A Randomized Controlled Trial (RCT) of a Story Telling Narrative Communication Intervention: We will conduct a two-arm RCT assigning participants at a ratio of 1:1 to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control: HIV-tailored plus attention-control interventions). Both arms will have eight weekly sessions of a 30-minute HIV-tailored cessation intervention (cognitive behavioral therapy plus nicotine patches). All research-related procedures will be conducted remotely.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The person who assesses follow-up assessments will be blind to treatment condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence Rate</measure>
    <time_frame>3 months</time_frame>
    <description>Women in both arms who reported having watched all four videos of the storytelling narrative intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-month Abstinence Rate</measure>
    <time_frame>3 months</time_frame>
    <description>Participants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy in Resisting Smoking Temptation.</measure>
    <time_frame>3 months</time_frame>
    <description>This scale assesses participants' confidence (self-efficacy) in resisting smoking temptation in nine specific situations. Each item score ranges from 1 (completely unconfident) to 5 (completely confident). The scale score is the sum of each item score and ranges from 9 to 45. Higher scores represent more confidence and better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Quitting Smoking Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV Infection Video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Storytelling Narrative Intervention</intervention_name>
    <description>In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
    <arm_group_label>HIV Infection Video</arm_group_label>
    <arm_group_label>Quitting Smoking Video</arm_group_label>
    <other_name>Cognitive Behavioral Counseling</other_name>
    <other_name>Nicotine Replacement Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        women who:&#xD;
&#xD;
          1. are able to speak English&#xD;
&#xD;
          2. self-report HIV infection and submit a supplementary document if necessary&#xD;
&#xD;
          3. are between the ages of 18 and 65&#xD;
&#xD;
          4. have been smoking at least 5 cigarettes a day for the past 6 months&#xD;
&#xD;
          5. own a mobile phone with an access to a video call application such as Skype, Imo,&#xD;
             Tango, and Face Time&#xD;
&#xD;
          6. are willing to quit smoking within the next 4 weeks from the baseline assessment; and&#xD;
&#xD;
          7. agree to use an approved form of birth control (e.g., oral medications, condoms, and&#xD;
             intrauterine devices) during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Women who:&#xD;
&#xD;
          1. are not able to speak English&#xD;
&#xD;
          2. are pregnant or lactating&#xD;
&#xD;
          3. have an active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use&#xD;
             Disorders Identification Test59)&#xD;
&#xD;
          4. self-report currently receiving treatment for a serious mental illness (e.g.,&#xD;
             schizophrenia and bipolar disorder) or&#xD;
&#xD;
          5. currently use any illegal substances excluding marijuana.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Who are biologically females.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sun S Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Massachusetts Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>February 17, 2019</results_first_submitted>
  <results_first_submitted_qc>August 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2019</results_first_posted>
  <last_update_submitted>August 2, 2019</last_update_submitted>
  <last_update_submitted_qc>August 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Boston</investigator_affiliation>
    <investigator_full_name>Sun S Kim</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>January 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03289676/Prot_000.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>January 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03289676/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>February 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03289676/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Quitting Smoking Film</title>
          <description>This arm viewed a storytelling narrative film of six women living with HIV taking about their success in quitting smoking.&#xD;
A total of 27 women were randomized into this arm and four women withdrew from the study right before receiving any of the allotted intervention.&#xD;
Of the remaining 23 women, 18 women received at least 80% of the allotted intervention, and all 23 women completed the study without any more loss.&#xD;
Outcome analysis was done separately with 27 women who were randomized into the arm and with 23 women who actually received any part of the allotted intervention.</description>
        </group>
        <group group_id="P2">
          <title>HIV Infection (an Attnetion-control) Film</title>
          <description>This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.&#xD;
A total of 26 women were randomized into this arm and 20 women received at least 80% of the allotted intervention. One was lost during the follow-up period and 25 women completed the study.&#xD;
Outcome analysis was done with 26 women who were randomized into the arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="25">Received 80% of the allotted intervention</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Quitting Smoking Video</title>
          <description>This arm watched a film in which six women living with HIV talk about why they decided to quit smoking and how they did.</description>
        </group>
        <group group_id="B2">
          <title>HIV Infection Video</title>
          <description>This arm watched an attention-control film in which four women talk about their everyday lives before and after the diagnosis of HIV.</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="27"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.81" spread="7.02"/>
                    <measurement group_id="B2" value="50.92" spread="6.76"/>
                    <measurement group_id="B3" value="51.38" spread="6.84"/>
                  </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="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerstrom Test for Nicotine Dependence</title>
          <description>The scale has 6 items with four dichotomous items and two 4-point items. Its total score is the sum of each item score and ranges 0 to 10. The higher values represent a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.19" spread="2.42"/>
                    <measurement group_id="B2" value="4.73" spread="2.16"/>
                    <measurement group_id="B3" value="5.47" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adherence Rate</title>
        <description>Women in both arms who reported having watched all four videos of the storytelling narrative intervention.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quitting Smoking Video</title>
            <description>This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.&#xD;
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
          </group>
          <group group_id="O2">
            <title>HIV Infection Video</title>
            <description>This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.&#xD;
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Adherence Rate</title>
          <description>Women in both arms who reported having watched all four videos of the storytelling narrative intervention.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.29</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>3-month Abstinence Rate</title>
        <description>Participants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quitting Smoking Video</title>
            <description>This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.&#xD;
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
          </group>
          <group group_id="O2">
            <title>HIV Infection Video</title>
            <description>This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.&#xD;
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>3-month Abstinence Rate</title>
          <description>Participants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy in Resisting Smoking Temptation.</title>
        <description>This scale assesses participants' confidence (self-efficacy) in resisting smoking temptation in nine specific situations. Each item score ranges from 1 (completely unconfident) to 5 (completely confident). The scale score is the sum of each item score and ranges from 9 to 45. Higher scores represent more confidence and better outcome.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Quitting Smoking Video</title>
            <description>This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.&#xD;
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
          </group>
          <group group_id="O2">
            <title>HIV Infection Video</title>
            <description>This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.&#xD;
Storytelling Narrative Intervention: In the first phase, three sections of a video, each for 5-7 minutes will be produced by &quot;Star&quot; story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy in Resisting Smoking Temptation.</title>
          <description>This scale assesses participants' confidence (self-efficacy) in resisting smoking temptation in nine specific situations. Each item score ranges from 1 (completely unconfident) to 5 (completely confident). The scale score is the sum of each item score and ranges from 9 to 45. Higher scores represent more confidence and better outcome.</description>
          <units>units on the scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5" spread="10.1"/>
                    <measurement group_id="O2" value="31.8" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.029</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio, log</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Quitting Smoking Video</title>
          <description>This arm received a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.</description>
        </group>
        <group group_id="E2">
          <title>HIV Infection Video</title>
          <description>This arm watched an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.</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="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Sun Kim</name_or_title>
      <organization>UNIVERSITY OF MASSACHUSETTS BOSTON</organization>
      <phone>6172875372 ext 6172875372</phone>
      <email>sun.kim@umb.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/NCT03289676
org study id: 2017147
nct id: NCT03289676
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
HIV has transformed into a chronic illness due to the advent of effective treatments in the
      absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs),
      including lung cancer, has increased three-fold among people living with HIV. NADCs now
      account for 50% of all cancers among the people. Smoking is one of the major contributing
      factors to lung cancer and smoking prevalence is substantially higher in this population than
      the general U.S. population. Smoking prevalence does not differ by gender among people living
      with HIV. Women of color, particularly African American women represent the majority of women
      living with HIV (WLHIV) followed by Latinas. WLHIV smoke at a rate almost 3 times higher than
      that for the general U.S. female population (e.g., 42% vs. 16%). The proposed study has two
      phases: 1) the development of a storytelling narrative communication (SNC) intervention that
      will be added to an established HIV-tailored smoking cessation intervention and 2) a two-arm
      randomized controlled trial (RCT) of the HIV-tailored intervention plus the SNC Intervention
      compared with the HIV-tailored intervention only. The investigators will develop narrative
      videos with three to five WLHIV who will be talking about their personal struggles with
      smoking and success in quitting. Preliminary study revealed that the established HIV-tailored
      intervention was effective only for short-term (≤ 2 months) abstinence. Many relapsed to
      smoking between the 2nd and 6th month of quitting. The investigators propose that the SNC
      intervention will be an effective strategy to sustain their quit efforts for long-term
      abstinence (≥ 6 months). A total of 60 WLHIV will be recruited and randomly assigned to
      either the experimental arm (a combination of HIV-tailored and SNC interventions) or the
      control arm (HIV-tailored intervention only). Specific aims of the study are to 1) Identify
      SNC intervention components that are rated high in transport and identification for use as an
      enhancement to an HIV-tailored smoking cessation intervention; 2) Determine the feasibility
      and acceptability of the SNC intervention for WLHIV by assessing the rate of recruitment and
      retention for feasibility and the degree of transport and identification for acceptability;
      and 3) Establish an effect size of HIV-tailored and SNC interventions for smoking cessation
      in comparison with the HIV-tailored smoking cessation intervention only for WLHIV, for
      subsequent grant applications.
The proposed study employs a mixed-methods research design. The investigators will first
      develop narrative videos in collaboration with community organizations of WLHIV in Boston.
      Second, the investigators will conduct a two-arm RCT assigning participants at a ratio of 1:1
      to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control:
      HIV-tailored intervention). Both arms have eight weekly sessions of a 30-minute HIV-tailored
      cessation intervention (cognitive behavioral therapy plus nicotine patches). The experimental
      arm will receive three 5-7 minute SNC videos, each per month between the first and third
      month of quitting, whereas the control arm will receive three 5-minute attention control
      videos at the same monthly interval.

      A total of 60 WLHIV will be recruited via online and offline advertisements and personal
      networks of community organizations and health care providers who work for people with HIV.
      To participate in the study, the following criteria must be met: women who 1) are able to
      speak English; 2) self-report HIV infection and submit a supplementary document if necessary;
      3) are between the ages of 18 and 65; 4) have been smoking at least 5 cigarettes a day for
      the past 6 months; 5) own a mobile phone with an access to a video call application such as
      Skype, Imo, Tango, and Face Time; 6) are willing to quit smoking within the next 4 weeks from
      the baseline assessment; and 7) agree to use an approved form of birth control (e.g., oral
      medications, condoms, and intrauterine devices) during the study period. Individuals will be
      excluded if they: 1) are not able to speak English; 2) are pregnant or lactating; 3) have an
      active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders
      Identification Test), 4) self-report currently receiving treatment for a serious mental
      illness (e.g., schizophrenia and bipolar disorder); or 5) currently use any illegal
      substances excluding marijuana.

      The investigators will recruit participants with frequent announcements of the study in
      Craigslist and paid online advertisements. The majority of intake interviews will be
      conducted via telephone, which will take 30 minutes at most. To prevent attrition, the
      investigators will execute several strategies, including tracking subjects at least every
      other month and providing incentives for follow-up testing. Counselors will proactively call
      participants prior to each therapy session and confirm the appointment a few hours before the
      session. A research assistant (RA) who will be blinded to the intervention condition will
      conduct all follow-up assessments via telephone calls and videoconferencing for saliva
      cotinine tests.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: : The proposed study has two phases.
Phase 1. Development of Narrative Video: We will first develop narrative videos in collaboration with community organizations of WLHIV in Boston. The video will be filmed in person at the University of Massachusetts Boston.
Phase 2. A Randomized Controlled Trial (RCT) of a Story Telling Narrative Communication Intervention: We will conduct a two-arm RCT assigning participants at a ratio of 1:1 to either one of the two arms (Experimental: HIV-tailored plus SNC interventions vs. Control: HIV-tailored plus attention-control interventions). Both arms will have eight weekly sessions of a 30-minute HIV-tailored cessation intervention (cognitive behavioral therapy plus nicotine patches). All research-related procedures will be conducted remotely.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The person who assesses follow-up assessments will be blind to treatment condition.
measure: Adherence Rate
time frame: 3 months
description: Women in both arms who reported having watched all four videos of the storytelling narrative intervention.
measure: 3-month Abstinence Rate
time frame: 3 months
description: Participants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.
measure: Self-efficacy in Resisting Smoking Temptation.
time frame: 3 months
description: This scale assesses participants' confidence (self-efficacy) in resisting smoking temptation in nine specific situations. Each item score ranges from 1 (completely unconfident) to 5 (completely confident). The scale score is the sum of each item score and ranges from 9 to 45. Higher scores represent more confidence and better outcome.
arm group label: Quitting Smoking Video
arm group type: Experimental
description: This arm will receive a storytelling narrative intervention by watching a video of women living with HIV taking about their success in quitting smoking.
arm group label: HIV Infection Video
arm group type: Active Comparator
description: This arm will watch an attention-control storytelling narrative intervention by watching a video of women living with HIV taking about their life after the diagnosis of HIV.
intervention type: Combination Product
intervention name: Storytelling Narrative Intervention
description: In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.
arm group label: HIV Infection Video
arm group label: Quitting Smoking Video
other name: Cognitive Behavioral Counseling
other name: Nicotine Replacement Therapy
criteria: 
gender: Female
gender based: Yes
gender description: Who are biologically females.
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sun S Kim
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Boston
investigator full name: Sun S Kim
investigator title: Associate Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Nicotine
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 