Smoking Cessation Intervention for Women With HIV/AIDS
Phase: NA
Conditions: AIDS/HIV
Sponsor: University of Massachusetts, Boston

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Title: Smoking Cessation Intervention for Women Living with HIV 
NCT NO: NCT02898597 
 
March 31, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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STUDY PROTOCOL 
 
Project Summary 
 
I. Rationale  
 
With the use of combined antiretroviral therapies, people with HIV infection now live longer than ever before. 
However, the burden of non-AIDS related health problems such as cardiovascular diseases and cancers on people 
living with HIV/AIDS has considerably increased, which undermines the health of those living with HIV [1-3]. 
Smoking is one of the major contributing factors to these health problems. Rates of cigarette smoking are 
substantially higher among people living with HIV than the general population: 40-75% versus 19% [2]. HIV 
positive women smokers have a 36% higher risk for developing AIDS and a 53% higher mortality when compared 
to nonsmokers with HIV/AIDS [2]. However, the rates of abstinence achieved by the existing smoking cessation 
interventions for this group are very modest, hovering around 6-9% [e.g., 4, 5]. These rates are substantially lower 
than the rates (e.g., 16-30%) obtained from the general smoker population [6]. There is thus an urgent need to 
develop a smoking cessation intervention that is effective for women living with HIV, which will promote and 
protect women’s health and their wellbeing.  
 
The HIV-related measures (instruments) used in this study identify demographic characteristics, attitudes, beliefs, 
and behaviors. Each of the measures is selected to collect data that affect personal health (secondary and tertiary 
levels). For example, stigma measures assess the degree of personalized (or self) stigma, HIV disclosure concerns, 
negative self-image, and concern with public attitudes toward people with HIV, which may be related to health 
promotion and wellness efforts, such as smoking cessation. There is empirical evidence that women perceive 
more HIV-related stigma than men, and those who have high perceived HIV-related stigma are less likely to 
disclose their HIV status to others, to seek treatment and to adhere successfully to their medication [4]. The 
demographics and all other instruments were chosen and reviewed by the Massachusetts Department of Public 
Health Office of HIV/AIDS and used successfully in a randomized controlled trial (RCT) completed by Dr. 
Rosanna DeMarco [7].  
 
The smoking-related measures are chosen because they provide valuable information to tailor cessation 
intervention components to the specific needs of a person, based on one’s smoking behavior and history of 
smoking cessation treatment. “Self-efficacy” has been identified as the only variable that significantly mediates 
the effect of smoking cessation intervention on abstinence [e.g., 8, 9]. There is ample evidence that people with 
depression and anxiety are less likely to succeed in smoking cessation [e.g., 10, 11]. We also include depression 
and anxiety measures to screen women who may have clinical depression or anxiety. They will be strongly urged 
to seek treatment for the condition. Of note, Dr. Kim is a licensed psychiatric advance nurse practitioner and those 
who earn a score of 16 or higher on the depression measure or 8 or higher on the Generalized Anxiety Disorder 
(GAD)-7 Scale will be interviewed for the diagnosis of depressive or anxiety disorder, respectively.  If they meet 
the diagnostic criteria for any of the disorders based on the DSM-V, they will be excluded. All of the measures 
have been successfully used in previous smoking cessation studies by Dr. Sun Kim [e.g., 12, 13].        
  
II.     Background Information 
 
Dr. Kim completed a smoking cessation intervention for Korean American women and is now preparing 
manuscripts for publication. She found that women with HIV and AIDS have many similarities with Korean 
American women in terms of their reluctance to seek smoking cessation treatment due to perceived stigma, and 
their preference for telephone counseling rather than in-person counseling [4, 5, 14]. Furthermore, similar to the 
low success rate of abstinence found among people with HIV infection, the rate of abstinence among Korean 
American women had been low (e.g., 5%) relative to their male counterparts (e.g., 17%) [15]. On the other hand, 
Dr. Kim’s videoconferencing smoking cessation intervention yielded an abstinence rate (28-30%), higher than 

 
 
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what has been reported for this population in previous studies [16], although findings are preliminary due to the 
nature of a pilot study. In Dr. Kim’s pilot trial, the smoking cessation interventions were tailored to the needs of 
Korean American women and the counseling is relatively intense (eight weekly 30-minute sessions) compared to 
the usual telephone counseling (four to six weekly 10-15 minute sessions). A meta-analysis of smoking cessation 
studies with the general US population revealed that high-intensity counseling support is more important for 
women than for men [17]. Thus, it is believed that if smoking cessation interventions are tailored to the specific 
needs of women with HIV and the cessation counseling is intense (e.g., eight weekly 30 minute sessions), women 
with HIV may achieve an abstinence rate that is higher than the rates reported in the literature [4, 5].  
 
III.    Methodology. 
 
The proposed study is a 2-arm parallel-group RCT of a smoking cessation intervention with 50 English-speaking 
women who have been diagnosed with HIV infection. Participants will be randomized at a ratio of 1:1 to either the 
video arm (n = 25) or the telephone arm (n = 25). The randomization will be based on computer-generated random 
numbers (http://www.randomizer.org/). The numbers will be written in a color-coded paper (the video arm = red 
and the control arm = blue). These papers will be placed in an envelope in order, which will be open right after the 
completion of the baseline assessment. Both arms will have eight weekly individualized counseling sessions and 
each session will be 30 minutes long. The study is conducted to determine the acceptability and feasibility of a 
videoconferencing smoking cessation intervention for women with HIV. It is also being conducted to estimate the 
effect of the videoconferencing smoking cessation intervention on abstinence compared with telephone counseling 
cessation intervention for women with HIV.  
 
Recruitment Procedures 
Participants will be recruited through the Sistah Powah Group, a group of women living with HIV whose purpose 
is to advance HIV prevention (primary, secondary, and tertiary prevention) and assist other HIV positive women in 
managing their co-morbidities through care engagement (e.g., ex-smoking behaviors).  We will also contact the 
local HIV AIDS Service Organizations (ASOs) by contacting leaders at each area personally and asking them to 
forward our email message (see below in Box 1) or through, explaining the study and offering fliers to be shared 
with clients or posted at their organizations. For example, Dimock Health Center, Boston Living Center, 
Multicultural AIDS Coalition, Massachusetts Department of Health Office of HIV/AIDs, Fenway Health Center, 
AIDS Action, AIDS Alabama, University of Mississippi Medical Center, and HOCC (Healing Our Community 
Collaborative).  
 
In addition, the following will be posted in online communities of people with HIV infection (e.g., HIV/AIDS 
Tribe and +supportgroups.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Who: All Women living with HIV infection who want to quit smoking. 
 
Study Title: Smoking Cessation Intervention for Women with 
HIV  
 
Contact Information: Please call Dr. Sun Kim 617-287-6831 or Ms. 
Sabreen Darwish 781-492-7096 for more information AND eligibility. 
 
The study is conducted at the University of Boston and the intervention 
is provided via phone calls.  Visa gift cards ($25-50) will be provided at 
each data collection point. 
Box 1 Online Posting Sample 

 
 
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Anyone interested will be asked to contact the research team (Dr. Sun Kim or Ms. Sabreen Darwish). Prior to the 
screening interview, a verbal consent (see the verbal consent form attached) will be obtained. If the caller is 
determined to be ineligible or refuses to participate, all data collected will be shredded immediately and will not be 
used in the study. Screening data for those who agree to participate but fail to provide a written consent form 
within two weeks from the screening interview will also be shredded. The screening data will be transferred to 
baseline assessment datasheet only after the caller provide a signed consent form. Then, the paper containing 
screening data will be shredded.     
 
 
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? 18 or older 
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 conditions: 
Suicidal Ideation, Alcohol Dependence, Schizophrenia, Schizoaffective Disorder, and Bipolar Disorder? 
No 
12. Have you ever attempted to kill yourself? No 
13. Do you currently use any illegal substances except marijuana (weed)? No 
14. Are you pregnant? No  
15. 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.  
16. Are you currently breast-feeding? No 
17. Do you agree to use birth control pills or devices during the study period? Yes  
18. Do you have access to a telephone and an Internet-connected computer? Yes        
 
Women who answer as above will be recruited into the study. They will be informed about the purpose and 
procedure of the study and then will be given time to ask questions if they have any. Once all questions being 
answered, Dr. Sun Kim (or Ms. Sabreen Darwish) will ask them to provide the following contact information: 
mailing address, e-mail address, at least two connected telephone lines (the participant’s cell phone, home phone or 
a third phone). Dr. Kim (or Ms. Darwish) will inform that they will be randomly selected to receive smoking 
cessation counseling either via a video call such as Face-time, Skype and Tango or by telephone. Individuals who 
are determined to be ineligible will be explained why they are not eligible for the study.  
 
 
 

 
 
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Consent Procedures 
We will e-mail or mail the Consent Form along with baseline research questionnaires to prospective participants 
who agree to participate in the study. The consent form will be accompanied with an information letter stating that 
they should read the consent form carefully and call us if they have any questions before signing the form. They 
can e-sign and return the form via e-mail, send a scanned consent paper via e-mail, or send a picture of a signed 
consent form via telephone message. For individuals who do not have e-mail account or prefer the form via post 
office mail, we will ask them to return the signed consent form in a self-addressed stamped envelope that will be 
provided. Dr. Kim or Ms. Darwish will make a one-time call to remind them of returning the consent form if they 
have not done so within the next two weeks. Dr. Kim will be available by telephone to help them complete the 
form if they have any questions about it.  Women who have not returned the signed consent form after the 
reminder call will be considered “not interested” in the study and their screening data will be shredded.   
 
Intervention Procedure  
The quit day will be determined between the second and fourth sessions based on one’s readiness for quitting. The 
first three sessions is focused on preparing participants for the quit day. A female therapist (Dr. Kim and Ms. 
Darwish) will educate neurobiological changes in the brain associated with nicotine addiction and how nicotine 
patches help them quit smoking. She will also train participants to learn behavioral strategies that have been found 
effective for dealing with symptoms of nicotine withdrawal. Post-quit sessions vary by individual needs depending 
on their abstinence status and severity of nicotine withdrawal symptoms. Below is the description of intervention 
components for each session in both videoconferencing and telephone counseling interventions.  
 
Table 1.  Intervention components of each session 
  
Session 
Intervention Components  
1st session 
 
 
 
 
2nd session 
 
 
 
 
 
3rd session 
 
 
 
 
 
4th session 
 
 
 
5th session 
 
 
6th session 
 
 
 
Assessment and Planning: Assess decisional balance between pros and cons of smoking; 
discuss and select the target quit date; discuss how to change one’s smoking pattern for 
quitting; assign a homework to do an hourly smoking log sheet; provide information what has 
been reported in tobacco literature on people with HIV infection; and instill hope that smoking 
cessation is possible with guidance and support. 
Health Benefits of Quitting: Assess the participant’s perceived health status, discuss 
immediate health benefits of quitting smoking; explain smoking increases bacterial and 
Pneumocystis pneumonia among people with HIV infection; inform women with HIV 
infection who smoke are more likely to develop AIDS and die from AIDS-related cancers and 
infections than those who don’t smoke; and encourage her to watch CDC’s Tips from Former 
Smokers: Smoking and HIV. 
Preparation for the Quit Day: Explain the neurobiological change of brain associated with 
nicotine dependence; explain nicotine patches, effects and side effects of the medication and 
how to manage side effects if they occur; counsel behavior changes in preparation for the 
target quit day; explain possible drug-to drug interactions between nicotine patches and HIV 
medications; and advise to download a free smartphone quit application such as QuitPal and 
StayQuit Coach. 
Nicotine withdrawal symptoms and Medication Management: Assess nicotine withdrawal 
symptoms, lapse/relapse, adherence to nicotine patches, and any side effects of nicotine 
patches; advise proper managements of any patch problems; and counsel behavioral coping 
strategies for the withdrawal symptoms. 
Lapses and Relapse: Assess nicotine withdrawal symptoms and lapses and relapse; discuss 
helpful cessation strategies including 4 Ds (delay, deep breathing, drink water, and discuss); 
and discuss about HIV smokers who courageously beat the deadly addiction.  
Stress and Coping Skills: Assess nicotine withdrawal symptoms and lapses and relapse; 
counsel to understand the effects of negative cognitions on negative moods (e.g., depression 
and anxiety), discuss positive coping skills; discuss any positive changes in the body; and 
encourage exercise and healthy living. 

 
 
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7th Session 
 
 
8th session 
Medication Adherence: Assess medication adherence; explain the importance of adherence 
to nicotine patches; and explain about dose reduction of nicotine patches (from step 1, 21mg 
to step 2, 14mg). 
Relapse Prevention: Discuss strategies to avoid lapses and relapse in high risk situations 
(e.g., meeting a friend with whom the participant used to smoke); and revisit the importance 
of quitting smoking and medication adherence. 
 
Participants in both arms will receive nicotine patches at two separate occasions: first, a 4-week supply of 21mg  
nicotine patches (14 mg if the participant smoke 5-9 cigarettes per day) and second, a 2-week supply of 14mg 
nicotine patches and a 2-week supply of 7mg nicotine patches together. All participants will also have education 
about the pharmacological mechanism of nicotine patches and their correct usage and management of possible side 
effects. Adherence to the medication will be monitored by asking participants to show used patches within the past 
week for the video arm and by asking participants the number of patches that have been used within the past week 
for the telephone arm.  
 
Researchers  
Dr. Kim has 13 years of research experience in multidisciplinary tobacco research with a focus on tailoring 
smoking cessation interventions for special populations such as Asian Americans, women, and people with mental 
illness. She recently completed a videoconferencing smoking cessation intervention study for Korean American 
women. She is also an advanced nurse practitioner with a specialty in mental health, and has provided cessation 
counseling to Asian and non-Asian smokers for the past 9 years. Dr. Sprague has 11 years of multidisciplinary 
research experience—focused on structural, health systems, behavioral and socio-cultural facilitators of and 
barriers to HIV treatment, prevention and support—primarily in Black women in South Africa and more recently 
in the Deep South (Alabama and Mississippi). Dr. DeMarco has 15 years of multidisciplinary research experience 
focused on HIV self-protective and risk factors that contribute to healthcare adherence and safe sex negotiation in 
low income, aging Black women.  
 
Counselors 
Dr. Kim and Ms. Darwish (a doctoral student in nursing) will provide cessation counseling. Prior to providing 
counseling, Ms. Darwish will have intensive trainings of tobacco dependence treatment and telephone cessation 
counseling. The trainings also include role-playing scenarios of common problems. 
 
Follow-up Assessment 
Women who have not returned a signed consent form will not participate in any follow-up assessment. Only 
participants who provide the consent form and report abstinence at 3-, and 6-month follow-ups will be asked to 
perform a saliva cotinine test via video calls.  The tests are done only after the completion of counseling and nicotine 
replacement therapy and those in the telephone arm will also perform the saliva test via video calls (the video call is 
done for the test not as part of the intervention).  For this, they will receive the saliva test kit via certified mail. 
Cotinine is the major proximate metabolite of nicotine. It has a long half-life approximately 15-19 hours and is 
widely used as a biological marker of nicotine exposure [18]. In this study, we will use the NicAlert® test that is a 
semi-quantitative measure of cotinine based on colorimetric immunoassay reaction. The test strip displays seven 
zones that represent a range of cotinine levels from 0 (0–10 ng/ml) to 6 (≥2000 ng/ml). Those who earn level 1 or 
higher will be treated as smoking irrespective of their self-report. Participants will also be assessed on the 
measures of self-efficacy in resisting smoking temptation, depression and anxiety to see any changes since 
baseline.  
 
Participants will receive a gift card worth $30 at baseline and $25 at each of the three follow-up assessments (post-
quit 1-, 3-, and 6-months) irrespective of their smoking status (abstinent vs. smoking). If they perform the saliva 
test, they will receive an additional gift card worth $25. Thus, those who perform the test will receive a gift card 
worth $50 at each time. The gift card will be mailed to the home address via a postage mail.   

 
 
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The study is a pilot project to obtain preliminary data for the feasibility and acceptability of a videoconferencing 
smoking cessation intervention for women living with HIV. Dr. Kim will identify and describe the time to 
recruitment and any barriers. She will also describe reasons for any refusals to study participation. She will 
compare abstinence and attrition rates at each follow-up. Participants will complete an Exit Survey, rating their 
overall satisfaction with the intervention that they have. 
 
IV.    Participant 
 
Inclusion criteria. To participate in this study, an individual must be a woman who: (1) is able to speak English, 
(2) self-reports having been diagnosed with HIV infection, (3) is between the ages of 18 and 75, (4) has smoked at 
least 5 cigarettes per day for the past 6 months, (5) has access to smartphone and computer (a desktop or laptop) 
with Internet/wireless, (6) is willing to quit smoking within the next 4 weeks from the first session of counseling, 
and (7) agrees to use an approved form of birth control during the intervention.  
 
Exclusion criteria. Individuals will be excluded based on any of the following criteria: (1) current involvement in 
other behavioral or pharmacological smoking reduction/cessation programs, (2) being pregnant or lactating, (3) 
active skin diseases, (4) serious alcohol use problems or current use of any illegal substances, or (5) active 
treatment for serious mental illness such as schizophrenia and bipolar I disorder. 
 
V.    Risks and Benefits 
 
Reasonably foreseen risks involved in this study are symptoms of nicotine withdrawal and potential side effects of 
nicotine patches, although these are recognized as relatively safe. Nicotine patch is one of the FDA approved first-
line cessation medications and can be purchased over the counter without a prescription [6]. The most common 
adverse effect of the patch is topical skin irritation, ranging from mild erythema to a more generalized skin 
reaction, frequently in participants with a history of eczematous dermatitis. Other potential side effects include 
nausea, vomiting, headache, light headedness, rapid heartbeat, and strange dreams. However, all of these side 
effects occur at about 10-15% and mostly are mild. They will disappear once a person stops using the medication. 
Another potential risk that may occur is related to the loss of privacy or breach of confidentiality. There is also a 
potential risk of embarrassment among those who report abstinence but their saliva cotinine test yields a positive 
result. False positive results are possible if participants have been exposed to secondhand smoke. In the rare event 
that a participant may express suicidal ideation. If this happens, Dr. Kim will evaluate the participant to assess 
suicidality of the participant using the Columbia-Suicide Severity Rating Scale (C-SSRS). If the counselor is Ms. 
Sabreen Darwish, she will immediately contact Dr. Kim at 201-388-2656 for evaluation who will evaluate the 
person within the next 2 hours. If the person is determined to be at immediate danger, Dr. Kim will inform that she 
has to break confidentiality and call 911.  If the participant is not determined to be at immediate risk, Dr. Kim will 
strongly encourage the person to talk to her primary healthcare provider or call the Suicide Hotline if she has 
suicidal ideation. Dr. Kim will follow up on the person weekly for the next month and then monthly until the 
person completes the study. 
 
Potential benefits. Participants may benefit because they will receive an evidence-based tobacco dependence 
treatment that has been developed and found effective in the general U.S. population when it is delivered via 
person-to-person. Their family members may also benefit if participants quit smoking because they are less likely 
to be exposed to secondhand smoke.  
 
VI.    Informed Consent 
 
Dr. Kim or Ms. Darwish will initiate the consent process right after the screening interview. The screener will read 
the consent form to the caller. The consent form clearly states that the research study involves 8 individual 

 
 
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videoconferencing or telephone sessions and time at each session lasts approximately 30 minutes. The consent 
form also states clearly that participation in the study is absolutely voluntary and they can withdraw from the study 
anytime without having to justify for their action. The prospective participant will be provided time to ask 
questions and all questions will be fully answered. Then, the person will be asked to provide contact information 
so that she can receive the consent form via e-mail or post-office mail. The person will be asked to sign/e-sign and 
return the form via e-mail/picture message or regular mail.  
 
Confidentiality  
Personal identifying information (names, addresses, phone numbers, etc.) will be kept in a separate file from other 
study data. We will code their personal information and store it in a locked cabinet in Room 301-03 at the Science 
Building of University of Massachusetts Boston, 100 Morrissey Blvd. Boston, MA 02125. The file of personal 
information will be kept until the participant complete the study that is 6w-month follow-up assessment and then 
will promptly be destroyed. Neither the subjects' names nor any other personal identifying information will appear 
in the questionnaires or on audiotapes of therapy sessions. Audiotapes and transcript will be kept for one year after 
the completion of the study and then destroyed. Neither participants’ names nor any other personal identifying 
information will appear on data files. Electronic files containing personal information will be password-protected. 
All smoking cessation materials including smoking log will be sent by postage mails.  
 
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