Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV
Phase: PHASE1
Conditions: HIV/AIDS
Sponsor: University of Massachusetts, Boston

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Study Title: Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living with 
HIV 
 
NCT Number: NCT03289676 
 
 
Date: 01/10/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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University of Massachusetts Boston Institutional Review Board Protocol 
 
 
A. Title: Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living with HIV 
 
B. Investigators: Sun S. Kim, PhD, RN, University of Massachusetts Boston  
                         Mary E. Cooley, PhD, RN, FAAN, Dana-Farber/Harvard Cancer Center  
                         Rosanna F. DeMarco, PhD, RN, APHN-BC, FAAN, University of Massachusetts Boston  
 
 
 
PROJECT DESCRIPTION 
 
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. We will develop 
narrative videos with three to five WLHIV who will be talking about their personal struggles with smoking and 
success in quitting. Our 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. We 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). 
 
STUDY AIMS 
The Purposes 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.  
 
 
SIGNIFICANCE OF THE STUDY 
People living with HIV now live longer because of the use of highly active antiretroviral therapy.1-3 However, the 
burden of non-AIDS related, especially, non-AIDS defining cancers (NADCs) has increased considerably and 
smoking is a profound cause of NADCs.3-6 These cancers now account for 50% of all cancers among those 
with HIV, with lung cancer being the most common and deadliest cancer.6-People living with HIV smoke 
cigarettes at much higher rates than the general U.S. population i.e., 40-80% versus 19%.1,7-9 There is no 
gender difference in smoking prevalence among people living with HIV. Women living with HIV (WLHIV) smoke 
at a rate almost three times higher than that for the general U.S. female population.9 Given the strong 
association between smoking and the development of lung cancer, smoking cessation interventions that are 
tailored to the group are critical to decrease the morbidity and mortality associated with lung cancer.  
Women of color, particularly, African American women in the United States represent the majority of WLHIV 
followed by Latinas.10 Blacks bear a disproportionate share of cancer burden, having the highest death rate 
and shortest survival of any racial or ethnic group for most cancers.11-13 Five-year relative survival is lower for 
Blacks than for Whites in most cancers at each stage of diagnosis.11 The majority of participants in smoking 

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cessation studies for people living with HIV were males (> 80%) and studies conducted with WLHIV are very 
scarce.14 Compared to men, women face more barriers to seeking treatment, including transportation and 
childcare issues.15  A smoking cessation intervention that can be accessible at home may be an alternative 
strategies to reach WLHIV. 
 
The effect of storytelling narrative communication (SNC) on an individual is largely determined by personal 
relevance, the perceived sensitivities to the risks and benefits that the stories effectively convey, identification 
with the storytellers, and the transformation of the individual from identification within the narrative.16-22This 
SNC intervention will relate one’s personal story, which has culturally sensitive and gender-specific narratives 
to WLHIV for strong identification. The effect of the intervention is to increase emotional engagement and to 
break down cognitive resistance through absorption in the storyline and identification with characters in the 
narrative.16-19 Another advantage of the narrative over alternative informational approaches includes its ability 
to more effectively reach audiences who have little knowledge of the health issues that may affect them. 
Storytelling, as a mode of narrative communication, is deeply rooted in African and Latino cultures and has 
been used to transmit ideas in education and history.23-29  Recent studies indicate that narrative intervention is 
an effective, sustainable approach for changing health behavior, including medication adherence and cancer 
screening.23-29  
 
Video call counseling has the advantage of “eye contact” that promotes therapeutic alliance while avoiding 
transportation hassles among WLHIV. Especially, those who live in a resource-limited area can have virtual 
face-to-face counseling of an HIV-tailored smoking cessation intervention. Video call also enables researchers 
to monitor adherence to nicotine replacement therapy (NRT) during the session and validate self-reported 
abstinence by conducting a real-time saliva cotinine test. Despite these great advantages, video call smoking 
cessation interventions are very scarce. Contrary to the belief that individuals from low socio-economic classes 
and ethnic/racial minorities are less likely to use electronic devices such as computers and mobile phones, 
recent data suggest that individuals from these backgrounds have high rates of mobile phone and text 
messaging usage.30,31 In our currently ongoing study with WLHIV, more than 80% of callers owned a 
smartphone. The proposed study is the first attempt to test the combined effect of video call counseling and the 
SNC intervention for smoking cessation in WLHIV. 
 
RESEARCH DESIGN AND METHODS 
 
     
Research Design: The proposed study has two phases.  
a. 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.  
b. 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). The experimental arm will receive three 5-
minute SNC videos (testimonial stories about 
successful quitting), each per month between the first 
and third month of quitting, whereas the control arm receive three 5-minute attention control videos 
(women talking about being diagnosed with HIV) at the same monthly interval. However, participants in 
the control arm will also receive the SNC videos talking about successful stories of smoking cessation 
right after the last follow-up assessment (3-month follow-up post-quit). The overall flow of the study is 
illustrated in Figure 1. All research-related procedures will be conducted remotely.  
 
Figure 1. The overall design of the study 
Phase 1 
Phase 2 

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Subjects: A total of 50 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 32), 4) self-report currently receiving treatment for a 
serious mental illness (e.g., schizophrenia and bipolar disorder); or 5) currently use any illegal substances. 
 
Recruitment and Retention Procedures: We will recruit participants via adwords.google.com, craigslist.com, 
and other offline advertisements such as advertisements on HIV/AIDS-related news magazines. We will first 
screen for eligibility and the following screening interview script will be used:  
 
1. Can you speak English? Yes 
2. Have you been diagnosed with HIV infection? Yes 
3. What kind of medications are you currently taking for HIV infection? (This question is asked as a way to verify HIV 
infection) 
4. How old are you? In between 18 and 65 
5. How many cigarettes on average have you been smoking a day?  5 or more cigarettes per day 
6. How long have you been smoking? At least for the past 6 months  
7. Are you willing to quit smoking within the next four weeks? Yes 
8. Are you willing to use nicotine patches? Yes 
9. Do you have any active skin disease? No 
10.  Have you had emotional complications such as feeling anxious and depressed around quitting smoking?  No. If 
the caller answers “yes” to this question, we will ask whether the quit attempt was made with or without assistance.  
We will also ask the severity of the complication(s). If the caller answers that the complications were so distressing 
and required treatment, she will be excluded from the study.  
11. Do you currently receive treatments (counseling and pharmacotherapy) for any of these illnesses: Depression, 
Alcohol Dependence, Schizophrenia, Schizoaffective Disorder, and Bipolar Disorder? No 
12. Do you currently use any illegal substances except marijuana (weed)? No 
13. Are you pregnant? No  
14. Are you currently using any method of birth control?  Yes. We will then ask the caller to specify what type of birth 
control she is currently practicing. If no, we will ask whether the caller is willing to practice birth control during the 
intervention period (3 months). Only those who use or agree to use an approved form of birth control (e.g., oral 
medications, condoms, Depo Provera injection, and intrauterine devices) will be accepted into the study.  
15. Are you currently breast-feeding? No 
16. Do you agree to use birth control pills or devices during the study period? Yes  
17. Do you have access to a telephone and an Internet-connected computer? Yes        
 
 
Those who are determined to be eligible will receive an informed consent form as an image (the consent form). 
They will be asked to read the form and given an opportunity to ask questions if they have any. After all 
questions answered, they will be asked to send a text message by typing their full name and date if they want 
to participate in the study. The text message will be photographed and kept as a record. The participant then 
will be interviewed via telephone-based video call for baseline questionnaires, which will take 30 minutes on 
average. Upon completion of informed consent form and baseline questionnaires, participants will have eight 
weekly counseling sessions of a 30-minute HIV-tailored cessation intervention (cognitive behavioral therapy 
plus nicotine patches). 
 
Study Procedures:  
 
1. Phase 1. Development of Narrative Videos: A video divided into three sections, each section for 5-7 
minutes will be produced by “Star” story tellers who are eloquent and have authentic personal experiences 
of quitting smoking. They will be WLHIV identified in collaboration with the community organization of 
WLHIV “Healing Our Community Collaborative”. Each woman will share her personal journey of quitting 
smoking focusing on (1) why she decided to quit smoking, (2) what helped her quit, (3) how she avoided 
smoking temptations, and (4) what changes she made to continue abstinence.  

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2. Phase 2. An RCT of a Storytelling Narrative Communication Intervention: Counseling contents will be 
primarily drawn from a cognitive behavioral therapy foundation, which is guided by Bandura’s Social 
Cognitive Theory.33,34 Within the theory, self-efficacy, that is, the conviction that one can successfully 
execute a behavior required to produce the outcome is viewed as the most influential determinant of the 
behavior and its appraisals are based on the following four: performance accomplishment, vicarious 
experience, verbal persuasion, and physiological state. Participants will have eight weekly counseling 
sessions and the duration of the sessions is approximately 200-240 minutes over 8 weeks. They will be 
counseled to enact small changes that are accomplishable, which will be the source of performance 
accomplishment. Both HIV-tailored and SNC interventions will augment self-efficacy via vicarious 
experience and verbal persuasion. The NRT will further increase self-efficacy by targeting physiological 
state. To prevent attrition, we will execute several strategies, including tracking subjects at least every 
month and providing incentives for follow-up tests. Counselors will proactively call participants prior to each 
therapy session and confirm the appointment a few hours before the session. A research assistant (RA) 
will conduct all follow-up assessments via telephone calls and video call for saliva cotinine tests. 
Regardless of smoking status, participants will receive a Visa gift card worth $25 at each follow-up 
assessment (post-quit 1, 2, and 3 months). Any participants who report abstinence at post-quit 3 months 
will be asked to do the salivary cotinine test via a video call on a smartphone and receive another Visa gift 
card worth $25 upon completion of the test. Those who complete all three follow-up assessments will 
receive one time bonus of a gift card worth $100.   
 
Individual counseling before the quit day. The main focus of the first session will be assessing each 
participant’ readiness for smoking cessation and accordingly setting the target quit day. The day will be 
usually set between the third and fifth sessions. Pre-quit sessions will be focused on preparing participants 
for the quit day, which includes counseling to delay smoking the first cigarette at least 30 minutes after 
awakening and expanding smoking free areas inside the house until complete smoking ban is established 
at least a week before the target quit day. As a form of knowledge development, the effects of smoking on 
people with HIV will also be highlighted during the first session. The second session will be geared toward 
explaining neurobiological changes associated with nicotine addiction and immediate health benefits of 
quitting. The session (usually the third or fourth one) right before the quit day will be focused on explaining 
the underlying treatment mechanism of transdermal nicotine patches and gums. During the session, 
correct usage of nicotine patches and gums, their possible side effects, and how to manage the side 
effects will be educated. Skills training for situational smoking temptations will be provided with role plays 
so that participants can learn coping strategies that are known to be effective for avoiding lapses and 
relapses.  
 
Individual counseling after the quit day. Post-quit sessions will vary by individual needs depending on 
abstinence status and the severity of nicotine withdrawal symptoms. Thus, the number of cigarettes 
smoked for the past 7 days will be assessed at each post-quit session using the 7-day Timeline Follow-back 
Scale.35 Minnesota Nicotine Withdrawal Scale will be assessed prior to counseling at each session and 
participants will be counseled accordingly depending on severity of nicotine withdrawal symptoms.36 
Participants will be counseled to utilize the 4D (Deep breathing, Drink Water, Distract, and Delay) 
behavioral strategies when they experience nicotine withdrawal symptoms.37  
 
Nicotine replacement therapy. Participants in both arms will receive a free supply of nicotine patches 
(Habitrol Patches, Novartis, Denmark) via post office mail at two separate occasions: first 4-week supplies 
of 21mg and then 2-week supplies of each 14mg and 7mg together. Those who smoke between 5-9 
cigarettes will receive 14mg for 6 weeks and then 7mg for 2 weeks. Those who report difficulty using 
patches due to skin reactions and who earn a high score (≥ 7) on the Fagerstrom Test for Nicotine 
Dependence38,39 will receive nicotine gums (2 or 4mg, Habitrol Gums, Novartis, Denmark). Adherence to 
nicotine patches and gums will be monitored asking number of patches and gums that they have used for 
the past 7 days. Prior to receiving nicotine patches and gums, participants will be instructed as to correct 
usage and possible side effects of the products, and which side effects that they should report immediately.  
Nicotine replacement products will be used in the study in accordance with their FDA approved labeling.  
 
Video Watching. Participants in both arm will be randomly assigned to either the SNC or attention-control 
interventions and accordingly receive the videos of either quitting smoking or being diagnosed with HIV 
infection, respectively. Participants in the control arm will also receive the SNC videos of quitting smoking 
right after the last data collection that is 3-month follow-up post-quit.   

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Saliva Cotinine Test. Participant who report abstinence at 3-month follow-up will receive two NicAlertTM test 
kits in 2-3 days via express mail. They will conduct the test at home and hence, there is no transportation 
of samples. Research staff will inform that participants should not open sealed test strips before the test. 
She/he will also inform them that they should not eat or drink for at least 30 minutes before the test. The 
staff person will assist them in testing by providing following step-by-step instructions.  
1. Take out collection tube and funnel from the white vinyl bag.  
2. Put the funnel in a collection tube. 
3. Spit into the collection tube through the funnel until the tube is half full.  
4. Discard the funnel and close the tube with a cap until you hear click. 
5. Tear off the sealed white wrap and take out the test strip inside  
6. Put the strip on the flat surface.  
7. Squeeze the collection tube while holding it upside down 
8. Have at least eight full drops of saliva drip from the tube onto the white padded area of the test strip 
(right below the three green arrows).  
 
A research staff member will closely monitor the whole process via the video call. She/he will be blind to 
treatment condition. The person can read the result of the test when the blue line on top of the strip 
disappears, which usually takes 20-30 minutes. She/he will ask participants to take a photo of the strip right 
after the video call and send it to her/him. Then, the person will share the photo with other research staff to 
validate one’s reading of the result. 
 
 
  
Study Measures and Assessment Procedures: Baseline and three follow-up assessments will be conducted 
by telephone survey. All measures (see Table 1 below) have been tested and validated for use with WLHIV. 
Those who report abstinence will receive NicAlert® test kits at 3-month follow-up by a post office mail right before 
the follow-up assessments. As described above, participants will be guided step-by-step to perform the test while 
the whole process being closely monitored by research staff via a video call.  
 
Table 1 Assessment schedule of study measures 
 
 
Power and Sample Size: This study aims to establish a preliminary effect size. In the currently ongoing study, 
abstinence rate for the video arm was 75.5% at post-quit 1 month but dropped to 20.0% at post-quit 3 months. 
For a two-sided test at a 5% significance level, 52 participants are required per arm to have 80% of power for 
abstinence rates 45.5% vs. 20%.46 As a pilot study, we will recruit 50 subjects (25 per arm).  
      
Data Analysis: Data analysis will be done in collaboration with the U54 Research Design and Analysis 
Core. Prior to data entry, data will be reviewed and double-checked for completeness and coding errors first by 
a research assistant and then by a data manager. An intention-to-treat analysis strategy will be used for 
cessation outcomes with missing values. 
 
Variables 
Measure 
Base 
1M* 
2 Ms* 
3 Ms* 
Demographics 
Demographic Datasheet  
 
 
 
 
History of HIV Infection  
Year of the diagnosis, CD4 cell count, and viral load 
 
 
 
 
HIV-medication Adherence 
CASE Medication Adherence Scale 40 
 
 
 
 
History of Smoking and Quitting  
Smoking and Quitting Datasheet  
 
 
 
 
Stigma and Secrecy 
HIV-related Stigma Scale 41 
 
 
 
 
Alcohol Use 
Alcohol Use Disorders Identification Test  (AUDIT) 32 
 
 
 
 
Depression 
Patient Health Questionnaire-9 42 
 
 
 
 
Anxiety 
Generalized Anxiety Scale-7 43 
 
 
 
 
Nicotine Dependence 
Fagerström Test for Nicotine Dependence 37,38 
 
 
 
 
Self-Efficacy  
Self-Efficacy Scale 44 
 
 
 
 
Nicotine Withdrawal 
Minnesota Tobacco Withdrawal Scale 36 
 
 
 
 
Narrative Engagement  
The Measure of Narrative Engagement 19 
 
 
 
 
Program Evaluation 
The Client Satisfaction Questionnaire 45 
 
 
 
 
Abstinence or Cigarette 
Consumption 
7-day Timeline Follow-back Smoking Behavior 35 
 
 
 
 
Saliva Cotinine Test (NicAlert®) 
 
 
 
 
Treatment Fidelity 
Intervention Fidelity and Competence Scale (Kim, unpublished work) 
 
 
 
 

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Specific Aim 1: Identify storytelling narrative communication (SNC) intervention components that are rated 
high in transport and identification* for use as an enhancement to an HIV-tailored smoking cessation 
intervention (*Narrative Understanding, Attentional Focus, Narrative Presence, and Emotional Engagement). 
Through two local networks of Black WLHIV in which Dr. DeMarco is a key collaborator, we will identify 
volunteers who have quit smoking and film them while they tell their story of quitting. We will ask them 
structured questions based on Bandura’s Self-Efficacy Model to elicit the story components. When the film is 
edited effectively for clarity of content and length, it will be tested for acceptability using a mix-methods 
approach. Using focus groups the film will be shown and participants will be asked what they liked the most 
and the least about the film. These data will be analyzed for saturation through thematic analyses.  
 
Specific Aim 2: Determine the feasibility and acceptability of an SNC intervention for smoking cessation 
for WLHIV by assessing 1) the rate of recruitment and retention for feasibility and 2) the degree of transport 
and identification for acceptability in the narrative enhancement. We will identify and describe the time to 
recruitment and any barriers. We will also describe reasons for study refusal and compare refusal rates by age 
ranges and number of cigarettes smoked per day, using χ2 and t-tests. We will compare attrition rates at each 
follow-up by intervention condition and abstinence status, using Mann-Whitney tests. Subjects will complete an 
Exit Survey, rating their overall satisfaction with the intervention that they have. They will also rate their 
experience with the SNC videos, using a 7-point Likert-type scale.45 In addition, the Measure of Narrative 
Engagement will be used as a quantitative indicator of 1) narrative understanding, 2) attentional focus, 3) 
narrative presence, and 4) emotional engagement.19 
 
      
Specific Aim 3: Establish an effect size of HIV-tailored smoking cessation and SNC interventions in 
comparison with the HIV-tailored smoking cessation intervention only for WLHIV by comparing 30-day 
abstinence rates at 6-month follow-up. We will evaluate the balance of baseline demographics and smoking 
behavior between the two arms, using t-tests or Mann-Whitney tests for continuous variables and χ2 tests for 
categorical variables. We will examine differences in continuous or 7-day point-prevalence abstinence rates 
between the two arms, using the χ2 tests. Individuals who are not available at follow-up assessments or yield a 
cotinine test result higher than the cutoff level of 0 (cotinine level 0-30mg/ml) will be all treated as smoking. We 
will calculate an effect size by comparing 30-day abstinence rates at 6-month follow-up point between the two 
arms. We will also explore longitudinal logistic regression models under the framework of generalized linear 
mixed models to examine the relationships between abstinence status and intervention conditions over time. 
 
 
PROTECTION OF HUMAN SUBJECTS 
 
Consent Form: The consent process described pertains to RCT subjects in Phase 2. Dr. Kim or research 
assistant (from now they will be referred to as research personnel) will conduct a brief screening interview 
when a person makes an initial contact. If the person is not eligible, the research personnel will stop the 
interview and destroy the data. If the person is eligible, the research personnel will explain the purpose of the 
study and its procedure, including voluntary nature of study participation, and random assignment into one of 
two intervention conditions. The research personnel will then send five page photos of the consent and allow 
time for the caller to read and ask questions. After having answered all questions accordingly, the research 
personnel will ask the caller to text her full name and date if she agrees to participate in the study. Once the 
text message is received, the research personnel will make a video call and collect baseline data.  
Potential Risks:  This study constitutes minimal risks to subjects and interventions provided are accepted 
forms of treatment such as behavioral therapy and over-the-counter medications. Nevertheless, subjects may 
have the following potential risks. First, subjects may experience nicotine withdrawal symptoms after quitting. 
Second, they may also experience side-effects of nicotine patches and gums. Although nicotine patches and 
gums are FDA approved first-line cessation medications and relatively safe, some may experience side effects 
that require a medical attention. The most common adverse effect of nicotine patch is topical skin irritation 
ranging from mild erythema to a more generalized skin reaction, frequently in subjects with a history of 
eczematous dermatitis. The most common adverse effect of nicotine gum are diarrhea, dry mouth, jaw pain, 
muscle pain, nervousness, sweating, and weakness. Other potential side effects of nicotine patches and gums 
include hypertension, dizziness, insomnia, abnormal dreams, and abdominal discomfort. Third, subjects may 
feel uneasy and depressed when they talk about their smoking particularly after relapsing to smoking. Fourth, 
potential risk is loss of privacy or breach of confidentiality. 

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Protection against Risks: To prevent or minimize nicotine withdrawal symptoms, we will provide via secured 
post office mails nicotine patches to all subjects and gums to those who earn a high score (≥ 7) on the 
Fagerström Test for Nicotine Dependence.38 Dr. Kim and students who are trained will counsel subjects, 
focusing on coping strategies that have been found effective in dealing with the withdrawal symptoms. For 
example, students will educate smokers a variety of behavioral strategies to manage the symptoms such 4Ds 
(Distract, Drink water, Deep breathe, and Discuss). Students will educate them about how and where to apply 
a nicotine patch, what to do if the patch comes off, how to handle common issues such as taking a shower, 
and how to dispose of a used patch. Students will also explain that they should chew nicotine gum slowly, until 
they feel a tingling sensation or a ‘peppery’ taste (usually after about 10 chews). Then rest it for one minute 
under their tongue, or between their cheek and teeth. This allows the nicotine to pass though the lining of their 
mouth. They should continue this ‘chew - rest’ sequence for 30 minutes, then throw away the gum. They 
should avoid eating and drinking 15 minutes before, and during, use of the gum (except for water). Acidic foods 
or drinks, such as orange juice, coffee, beer and soft drink, interfere with the amount of nicotine passing 
through the lining of their mouth from the gum. 
 
During sessions, counselors will educate side effects of nicotine patches/gums and their proper managements. 
They will provide an emergency contact number (Dr. Kim’s cell phone) to all subjects and instruct them to call 
the number if they experience any serious side effects of the medication such as nausea and vomiting.  
Counselors will monitor every subject weekly for the first four weeks of the medication and monthly thereafter 
during the remaining 4-weeks of the medication and at 1- and 3-month follow-ups. Nicotine intake during 
pregnancy is associated with an increased risk for spontaneous abortion, increased prenatal mortality, and with 
low infant birth weights.  The safety of nicotine in nursing infants has not been clearly established.  Thus, we 
will exclude pregnant women, nursing mothers, and women who are not using an acceptable form of birth 
control from the study.  
 
Data and Safety Monitoring: Dr. Kim will document adverse events, and share copies of all forms and 
correspondences related to the adverse event with subjects’ primary care provider if necessary after we obtain 
permission from subjects. Dr. Kim will promptly report to the IRB any unanticipated problems involving risks to 
subjects or others (i.e., events meeting the criteria described in section 1 of the UMB unanticipated problem 
report form. Dr. Kim will also periodically report a summary of the adverse events to the IRB or when we seek 
an annual re-approval of the protocol at a minimum. The summary will include the number of subjects enrolled 
in the study and a summary of graded adverse events to date. Dr. Kim will evaluate the frequency and severity 
of any adverse events and determine if modifications to the protocol or consent form are required. 
 
Confidentiality: All study procedures will be in accordance with the approval by the UMB Institutional Review 
Board. To ensure confidentiality, each participant will be assigned a unique study ID code, collected data will 
only be linked through a code number to any identifying information such as name and telephone number. The 
file linking participants’’ names and code numbers will be stored in a locked file cabinet in the office of Dr. Kim. 
All data obtained from participants will be kept confidential and only aggregated, combined results will be 
reported. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCES 
1. Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg 
SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus 
infection. HIV Outpatient Study Investigators. New England Journal of Medicine. 1998; 338(13):853–
860.  
2. Sterne JA, Hernan MA, Ledergerber B, Tilling K, Weber R, Sendi P, Rickenbach M, Robins JM, Egger 
M; Swiss HIV Cohort Study. Long-term effectiveness of potent antiretroviral therapy in preventing AIDS 
and death: a prospective cohort study. Lancet. 2005; 366(9483):378–384.  
3. Lifson AR, Neuhaus J, Arribas JR, van den Berg-Wolf M, Labriola AM, Read TR; INSIGHT SMART 
Study Group. Smoking related health risks among persons with HIV in the strategies for management 
of antiretroviral therapy clinical trial. American Journal of Public Health. 2010;100(10):1896-1903. 
4. Engels EA, Biggar RJ, Hall HI, Cross H, Crutchfield A, Finch JL, Grigg R, Hylton T, Pawlish KS, McNeel 
TS, Goedert JJ. Cancer risk in people infected with human immunodeficiency virus in the United States. 
International Journal of Cancer. 2008;123(1):187–194.  
5. Shiels MS, Pfeiffer RM, Gail MH, Hall HI, Li J, Chaturvedi AK, Bhatia K, Uldrick TS, Yarchoan R, 
Goedert JJ, Engels EA. Cancer burden in the HIV-infected population in the United States. Journal of 
National Cancer Institute. 2011;103(9):753–762.  
6. Shiels MS, Althoff KN, Pfeiffer RM, Achenbach CJ, Abraham AG, Castilho J, Cescon A, D'Souza G, 
Dubrow R, Eron JJ, Gebo K, John Gill M, Goedert JJ, Grover S, Hessol NA, Justice A, Kitahata M, 
Mayor A, Moore RD, Napravnik S, Novak RM, Thorne JE, Silverberg MJ, Engels EA; North American 
AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of the International Epidemiologic 
Databases to Evaluate AIDS (IeDEA). HIV Infection, Immunosuppression, and Age at Diagnosis of 
Non-AIDS-Defining Cancers. Clinical Infectious Diseases. 2017;64(4):468-475. 
7. Pacek LR, Harrell PT, Martins SS. Cigarette smoking and drug use among a nationally representative 
sample of HIV-positive individuals. American Journal of Addiction. 2014;23(6):582-590. 
8. Mdodo R, Frazier EL, Dube SR, Mattson CL, Sutton MY, Brooks JT, Skarbinski J.. Cigarette smoking 
prevalence among adults with HIV compared with the general adult population in the United States: 
cross-sectional surveys. Annals of Internal Medicine. 2015;162(5):335-344.  
9. Weinberger AH, Smith PH, Funk AP, Rabin S, Shuter J. Sex differences in tobacco use among persons 
living With HIV/AIDS: A systematic review and meta-analysis. Journal of Acquired Immune Deficiency 
Syndrome. 2017;74(4):439-453. 
10. CDC.gov [homepage on the Internet].  HIV Surveillance Report. Atlanta/GA: Center for Disease Control 
and Prevention Online resource [updated September 1; cited 2015]. Available from 
http://www.cdc.gov/hiv/library/reports/surveillance.html. Accessed October 25, 2016. 
11. DeSantis CE, Siegel RL, Sauer AG, Miller KD, Fedewa SA, Alcaraz KI, Jemal A. Cancer statistics for 
African Americans, 2016: Progress and opportunities in reducing racial disparities. CA: A Cancer 
Journal for Clinicians. 2016;66(4):290-308. 
12. Pathak EB. Mortality among Black men in the USA. Journal of Racial and Ethnic Health Disparities. 
2017 Feb 24. doi: 10.1007/s40615-017-0341-5. [Epub ahead of print] 
13. Durani U, Go RS. Racial and ethnic disparities in the survival of adolescents and young adults with 
acute myeloid leukemia: a retrospective study using the US National Cancer Data Base. Leukemia and 
Lymphoma. 2017;58(5):1184-1189. 
14. Moscou-Jackson G, Commodore-Mensah Y, Farley J, DiGiacomo M. Smoking-cessation interventions 
in people living with HIV infection: a systematic review. The Journal of the Nurses Association in AIDS 
Care. 2014; 25(1):32-45. 
15. Tuchman E. Women and addiction: the importance of gender issues in substance abuse research. 
Journal of Addictive Diseases. 2010;29(2):127-138. 
16. National Cancer Institute. Making health communication programs work: A planner's guide. 2002. 
Available from: http://www.cancer.gov/publications/healthcommunication/pink-book.pdf 
17. Green MC, Brock TC. The role of transportation in the persuasiveness of public narratives. Journal of 
Personality and Social Psychology. 2000;79:701-721.  

10          IRB Protocol_SSK 
 
18. Cohen J. Defining identification. A theoretical look at the identification of audiences with media 
characters. Mass Communication & Society. 2001;4:245-264. 
19. Busselle R, Bilandzic, H. Measuring narrative engagement. Media Psychology. 2009;12:321-347.  
20. Frank LB, Murphy ST, Chatterjee JS, Moran, MB, Baezconde-Garbanati L. Telling stories, saving lives: 
Creating narrative health messages. Health Communication. 2015;30:154-163. 
21. Lee H, Kim M, Allison J, Kiang P. Development of a theory-guided storytelling narrative intervention to 
improve HPV vaccination behavior: Save our daughters from cervical cancer. Applied Nursing 
Research. 2017;34:57-61. 
22. Hinyard LJ, Kreuter MW. Using narrative communication as a tool for health behavior change: a 
conceptual, theoretical, and empirical overview. Health Education & Behavior. 2007;34(5):777–792. 
23. Utz SW, Williams IC, Jones R, Hinton I, Alexander G, Yan G, Moore C, Blankenship J, Steeves R, 
Oliver MN. Culturally tailored intervention for rural African Americans with type 2 diabetes. Diabetes 
Education. 2008;34(5):854–865. 
24. Erwin DO, Ivory J, Stayton C, Willis M, Jandorf L, Thompson H, Womack S, Hurd TC. Replication and 
dissemination of a cancer education model for African American women. Cancer Control. 2003;10(5 
Suppl):13–21. 
25. Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin 
D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood 
pressure: a randomized trial. Annals of Internal Medicine. 2011;154(2):77–84. 
26. Njeru JW, Patten CA, Hanza MM, Brockman TA, Ridgeway JL, Weis JA, Clark MM, Goodson M, 
Osman A, Porraz-Capetillo G, Hared A, Myers A, Sia IG, Wieland ML. Stories for change: development 
of a diabetes digital storytelling intervention for refugees and immigrants to Minnesota using qualitative 
methods. BMC Public Health. 2015;15:1311. doi:10.1186/s12889-015-2628-y. 
27. Larkey LK, Gonzalez J. Storytelling for promoting colorectal cancer prevention and early detection 
among Latinos. Patient Education and Counseling. 2007;67(3):272-278. 
28. Cherrington A, Williams JH, Foster PP, Coley HL, Kohler C, Allison JJ, Kiefe CI, Volkman JE, Houston 
TK. Narratives to enhance smoking cessation interventions among African-American smokers, the 
ACCE project. BMC Res Notes. 2015;8:567. doi:10.1186/s13104-015-1513-1. 
29. Kong G, Ells DM, Camenga DR, Krishnan-Sarin S. Text messaging-based smoking cessation 
intervention: a narrative review. Addictive Behaviors. 2014;39(5):907-917. 
30. Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking 
cessation. Cochrane Database of Systematic Reviews. 2016 Apr 10;4:CD006611. doi: 
10.1002/14651858.CD006611.pub4. 
31. Kim SS, Sitthisongkram S, Bernstein K, Fang H, Choi W, Ziedonis D. A videoconferencing smoking 
cessation intervention for Korean American women: preliminary findings. International Journal of 
Women’s Health. 2016;7(8):453-462.  
32. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG. The Alcohol Use Disorders Identification 
Test: Guidelines for use in primary care (2nd ed.). World Health Organization. 2001. 
33. Bandura A. Social foundations of thought and action: A social cognitive theory. Prentice-Hall, Inc. 1986. 
34. Bandura, A. Self-efficacy: Toward a unifying theory of behavioral change. Psychological Review. 
1977;84:191–215.  
35. Sobell LC, Sobell MB. Alcohol consumption measures. In J.P Allen and V.B. Wilson, eds. Assessing 
alcohol problems: A guide for clinicians and researchers. National Institute on Alcohol Abuse & 
Alcoholism: Bethesda, MD. 2003. 
36. Hughes JR, Hatsukami D. Errors in using tobacco withdrawal scale. Tobacco Control. 1998;7:92-93.   
37. Fiore M, Jaen CR, Baker T, et al. Treating tobacco use and dependence: 2008 update. Rockville, MD: 
US Department of Health and Human Services; 2008. 
38. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerström test for nicotine 
dependence: a revision of the Fagerstrom Tolerance Questionnaire. British Journal of Addiction. 
1991;86(9):1119-1127. 
39. Fagerström, KO. Determinants of Tobacco Use and Renaming the FTND to the Fagerström Test for 
Cigarette Dependence. Nicotine & Tobacco Research. 2012;14(1):75-78. 
40. Sherbourne CD, Hays RD, Ordway L et al. Antecedents of adherence to medical recommendations: 
Results from medical outcomes study. Journal of Behavioral Medicine. 1992;15(5):447-456.  
41. Berger BE, Ferrans CE, Lashley FR. Measuring stigma in people with HIV: Psychometric assessment 
of the HIV Stigma Scale. Research in Nursing and Health. 2001;24:518-529.  
42. Kroenke K, Spitzer RL, Williams JBW. The PHQ-9: Validity of a brief depression severity measure. 
Journal of General Internal Medicine. 2001;16(9):606-613. 

11          IRB Protocol_SSK 
 
43. Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety 
disorder (The GAD-7). Archives of Internal Medicine. 2006;166(10):1092–1097.  
44. Velicer WF, DiClemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an 
integrative model. Addictive Behaviors. 1990;15:271-283. 
45. Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: 
Development of a general scale. Evaluation and Program Planning. 1979;2:197-207. 
46. Power G. G*Power 3, 2003. [2003; cited October 10 2010]. Available at http://www.mp3-
converter.biz/g-power-mac.htm