Clinical trial NCT04609514
Conditions: HIV/AIDS Smoking Cessation Tobacco Use Disorder
Sponsor: Duke University
Start date: 2021-01-25; Completion date: 2022-06-02
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S. Clinical Practice Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. Both apps will be integrated with NRT and ongoing HIV clinical care.

Detailed description:

Arms: arm 1: A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study. arm 2: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.
Interventions: intervention 1: Learn to Quit-HIV intervention 2: QuitGuide intervention 3: Nicotine patch intervention 4: Smartphone coaching
Intervention descriptions: intervention 1: A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. intervention 2: A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. intervention 3: All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches. intervention 4: All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app.

Protocol documents:
Prot_SAP_001.pdf: 
7/1/2020 
 
 
 
 
 
 
 
 
 
Early-phase Studies of a Tailored 
Evidence-Based Smoking Cessation 
mHealth App for Persons Living with HIV 
(PLWH) 
 
Phase 2: Pilot RCT of LTQ-H 
Study Protocol 
 
NCT04609514 
 
 


2 
 
 
 
1.0. Significance 
PLWH are more likely to die from tobacco use than from HIV itself. Scalable and evidence-based 
smoking cessation interventions in line with current health consumer trends are highly needed in order to 
improve quality of life and curb mortality rates among PLWH. Moreover, the incorporation of state-of-the-art 
technology to improve access to hard-to-reach populations and settings has been identified as a high-priority 
research opportunity in the Trans-NIH Plan for HIV-Related Research. mHealth apps tailored to the specific 
needs of PLWH hold promise for reducing tobacco dependence among PLWH and HIV-related health 
disparities. However, despite promising initial evidence supporting the use of smoking cessation apps, there is 
a shortage of rigorous early-phase research developing and testing smoking cessation apps in general, and 
among PLWH specifically. The central premise of this research is that LTQ can be tailored using rigorous 
research methodology to meet the needs of PLWH smokers. This phase of the project will capitalize on 
background analytics and qualitative methods to evaluate the acceptability and preliminary efficacy of LTQ-H, 
a smoking cessation app iteratively designed for smokers with HIV by smokers living with HIV. 
2.0. Goals and Aims 
2.1. Aims 
The overarching goals of this phase of the research are to evaluate the feasibility, acceptability, and 
preliminary efficacy of a tailored smoking cessation app for PLWH, “Learn to Quit-HIV” or “LTQ-H” for short, 
which was iteratively developed in the first phase of research. Specifically, we propose to conduct a feasibility, 
acceptability, and preliminary efficacy trial comparing LTQ-H (n=30) to an app based on U.S. Clinical Practice 
Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. NCI QuitGuide will match LTQ-H’s format 
of delivery, dose, and duration. Both apps will be integrated with NRT and ongoing HIV clinical care. Primary 
outcomes: feasibility (i.e., recruitment rates, retention, app engagement); acceptability (i.e., usability, user 
experience, perceived utility). Secondary outcomes: cigarettes smoked per day, quit attempts, biochemically 
verified abstinence, NRT adherence and participant safety. Successful execution of this aim will indicate the 
feasibility, acceptability, and preliminary efficacy of LTQ-H. 
2.2. Outcomes 
Primary Outcomes: 
(1) Recruitment rates and participant retention, which will be collected and monitored throughout study 
duration 
(2) App engagement, which will be evaluated from background analytics data consisting of frequency 
and duration of app use, objective background analytics measures used in our previous work. We 
will use Google Analytics and our Data Transfer Agreement with smokefree.gov to gather this 
metric 
(3) App usability measured with the Systems Usability Scale 
(4) User Experience, extracted via thematic analysis of transcripts of semi-structured interviews. As in 
previous early-phase research by Dr. Vilardaga, these interviews will occur at the end of treatment 
(Week 12) 
Secondary Outcomes: 


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(1) Cigarettes per day (CPD) will be measured daily with the tracking feature embedded within each 
app. LTQ contains a feature that allows users to enter how many cigarettes they smoked at the end 
of the day 
(2) Quit attempts defined as self-reported no smoking at all for 24 hours, and time to 7-day relapse will 
assessed via a Timeline Follow Back interview at Weeks 4, 8 and 12  
(3) 7-day point prevalence abstinence will be determined by responses to a standard self-report item 
(i.e., not smoking even a puff of a cigarette within the last 7 days) and breath CO<5 ppm at Week 
12 
(4) Adherence to NRT will be measured daily with the app tracking feature, as well as brief interviewer-
administered questionnaires at Weeks 4, 8, and 12  
(5) Participant Safety will be assessed by monitoring all adverse events during the 12-week period and 
in close collaboration with their medical providers 
3.0. Participants 
3.1. Inclusion Criteria 
The inclusion criteria are meant to be broad enough to capture a wide swatch of smokers with HIV. However, 
there are medical requirements as we will be giving participants a study drug (NRT). Also, participants will 
have to want to quit smoking. Therefore, the inclusion criteria are as follows: 
(1) HIV-positive 
(2) Currently engaged with an HIV care provider 
(3) Self-report smoking 5 cigarettes or more per day during the past 30 days 
(4) Age 18 years or older 
(5) Current interest in quitting smoking 
(6) Currently own a functioning Apple or Android smartphone 
3.2. Exclusion Criteria 
(1) General Exclusion Criteria 
a. No desire to quit smoking 
b. Inability to provide informed consent 
c. Any medical condition or concomitant medication that could compromise subject safety or 
treatment, as determined by the Principal Investigators and/or Study Physician 
(2) Medication Exclusion Criteria 
a. Presence of contraindications for nicotine patch 
b. Previous allergic reaction or hypersensitivity to nicotine patch (lifetime) 
c. Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., 
bupropion, varenicline) 
(3) Medical Exclusion Criteria 
a. Uncontrolled high blood pressure/hypertension 
b. Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study  
(4) Alcohol/Drug Exclusion Criteria 
a. Current untreated and unstable diagnosis of alcohol/substance abuse or dependence 
(eligible if past abuse/dependence and if receiving treatment and stable for >30 days) 


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3.3. Target Population Distribution 
Inclusion of Women and Minorities: The study will be open to males and females, and all ethnic groups. The 
population of Durham County, North Carolina is approximately 52% female and 48% male. According to U.S. 
census 2013 data, the racial/ethnic composition of Durham County, NC is 53.1% Caucasian, 38.5% African-
American, and 4.8% Asian, with 13.5% reporting Hispanic ethnicity. We plan to recruit a sample that is 
representative of the Durham County area with respect to gender and race/ethnicity. 
4.0. Study Overview 
1. Eligibility and Consent: PLWH who provisionally qualify based on a phone screen will be invited to attend 
a remote Zoom screening visit. Informed consent will be obtained, and participants’ interest in quitting, HIV 
and smoking statuses will be evaluated. Individuals will be screened to ensure that they own an Apple or 
Android smartphone, are not pregnant (if female), and are medically eligible to use NRT. Our study 
physician will evaluate their medical eligibility. In addition, we will obtain a signed Release of Information 
from potential participants to closely work with their own medical providers to monitor adverse events, 
dispensing of NRT, and overall participant safety. 
2. Randomization: Participants will be allocated to conditions using 1:1 randomization. 
3. Interventions: Participants will be assigned to LTQ-H or NCI QuitGuide. All participants will receive a 
standard 8-week course of NRT (transdermal nicotine patches starting at 21mg/24h) following 
recommendations contained in the U.S. Clinical Practice Guidelines.  
4. Background Analytics: Research staff will instruct participants on how to install the study app onto their 
personal smartphones and will tell them how to add a study ID in the app that will be used to retrieve 
background analytics information (Google Analytics) from both the LTQ-H and NCI QuitGuide apps. 
5. Follow-Up Visits: Visits will occur at 4, 8 and 12 weeks post-randomization. During these visits we will 
assess smoking and smoking abstinence, new or changes in existing adverse events and user experience 
with the assigned app. We will biochemically verify self-reported smoking abstinence at week 12. 
4.1. Timeline 
 
Participants who are enrolled in Phase 2 of the study will participate over the course of 12 weeks, which 
includes a screening visit, randomization visit, plus 3 monthly follow-up visits.  
 


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5.0. Interventions and Measures 
5.1. Interventions 
Learn to Quit-HIV (LTQ-H) 
Learn to Quit (LTQ) is an Android/iOS smoking cessation app developed by Dr. Vilardaga. It was originally 
developed for persons with serious mental illness (SMI). However, in this study we will be using a new version 
of LTQ called LTQ-H. LTQ-H was iteratively designed through a user-centered design study in persons living 
with HIV to evaluate key usability barriers and design requirements for this population. LTQ is based on 
Acceptance and Commitment Therapy (ACT), a mindfulness-based intervention with promising results for 
smoking cessation in several clinical trials. LTQ includes 28 Modules that encourage the learning and practice 
of three processes of change (e.g., awareness of urges to smoke, openness to experiencing urges, and 
commitment to specific values for quitting), as well as adherence to U.S. Clinical Practice Guidelines (e.g., use 
of medications). The app also includes ecological momentary assessments (e.g., self-tracking) of mood, 
nicotine replacement therapy (NRT) use, cravings to smoke, acceptance of cravings, and cigarettes smoked 
daily. 
QuitGuide (QG) 
QG is an app developed by the National Cancer Institute (NCI) based on US Clinical Practice Guidelines. The 
app encourages users to pick a quit date upon starting the app. The app also contains mood and cigarette 
craving tracking, and tracking of number of days that the user was smoke-free or slipped. It also contains a 
journaling feature and the option to opt-in to location- or time-based notifications. 
Nicotine Replacement Therapy (NRT) Patches 
All participants will receive an 8-week course of NRT patches regardless of app assignment. Based on the 
number of cigarettes-per-day (CPD) reported, they will receive either a standard or adjusted course for the first 
4 weeks of patch use. 
 
 
Standard 
Adjusted 
CPD at baseline 
≥ 10 
< 10 
Starting dose 
21 mg/24 hours 
14 mg/24 hours 
Following the first 4 weeks of use, participants will use 14 mg/24 hour patches for 2 weeks, followed by 7 
mg/24 hour patches for the last 2 weeks (regardless of starting dosage). 
5.2. Measures 
• 
Carbon Monoxide Breath Test: The coVita iCO Smokerlyzer® breath carbon monoxide monitor will be 
used to obtain biochemical verification of smoking abstinence at the Week 12 visit (cutoff: CO < 5 ppm = 
abstinent). Only participants who self-report abstinence will be sent these devices. The user blows into the 
handheld monitor, which provides feedback about the user’s smoking status and nicotine dependence by 
displaying carbon monoxide (CO) levels in the body. This device is available for the public to purchase, 
though clinicians often use it for their clients to monitor their CO levels over time. We have no plans to 
study the item itself, or submit data about this to the FDA. This measure takes approximately 1 minute to 
complete. 


6 
 
 
 
• 
Demographics: A series of questions assessing common demographic information such as sex, 
race/ethnicity, income, etc. We administer this measure to subjects at the screening session only. This 
measure takes approximately 5 minutes to complete. 
• 
Brief Medical History and Brief Medical History Follow-Up Questionnaire: This questionnaire asks 
about multiple aspects of the participant’s medical history including questions about chronic diseases and 
medications. The Follow-Up questionnaire goes into more detail about any conditions that the participant 
endorsed, including their specific diagnosis and what medications they are taking to treat the condition. 
These two questionnaires take approximately 20 minutes to complete. 
• 
Drug Abuse Screening Test (DAST): A 10-item screening tool for assessing drug use (excluding alcohol 
and tobacco use) in the past month. It will be used to inform whether someone meetings eligibility criteria, 
and given at the consent session. This measure takes approximately 2 minutes to complete. 
• 
Alcohol Use Disorders Identification Test (AUDIT): A brief assessment of drinking behavior and 
detecting possible alcohol dependence. This measurement will be used to inform whether someone 
meetings eligibility criteria, and given at the consent session. It takes approximately 2 minutes to complete. 
• 
Drug Use Questionnaire (12+1 Month and 1 Month): This questionnaire asks about past drug use. The 
questionnaires asks participants about 15 different types of drugs, plus a 16th type for “Other.” The 12+1 
Month questionnaires asks about drug use in the past year AND the past 30 days, whereas the 1 Month 
version asks only about the past 30 days of use. This questionnaire captures whether or not someone used 
the drug in question, and how often it was used (number of days). This measure takes approximately 3 
minutes to complete. 
• 
Mini International Neuropsychiatric Inventory, Version 5.0 (MINI): A brief standardized structured 
interview for the major Axis I psychiatric disorders in the ICD-10 with good reliability and validity. This 
measure will help determine if the participant is experiencing any psychiatric symptoms. This measure 
takes approximately 20 minutes to complete. 
• 
Columbia-Suicide Severity Rating Scale (CSSRS): This 6-item survey provides prompts to assess any 
suicidal ideation and behavior that the participant may be exhibiting, with higher scores indicating a more 
frequent presence of suicidal ideations and/or behaviors. This measure takes approximately 5 minutes to 
complete. 
• 
Depression Anxiety Stress Scale-21 (DASS-21): This 21-item symptom scale assesses symptoms of 
depression, anxiety, and stress that occurred in the past week. Each item is rated on a Likert-style scale 
from 0-3 with higher scores indicating a more frequent occurrence of symptoms. This measure takes 
around 3 minutes to complete. 
• 
Brief Symptom Inventory (BSI): A brief 53-item self-report symptom scale. Assesses psychiatric 
symptoms within the last 7 days, and will be used to track symptoms at baseline and follow-ups. This 
measure takes approximately 5 minutes to complete. 
• 
Stigma Mechanisms Scale: This scale is broken down into 3 sections, each measuring a different type of 
stigma related to HIV status: internalized, anticipated, and enacted forms of stigma. There are 24 items 
which participants rate on a Likert-style scale from 1-5 with higher scores indicating greater stigma.  
• 
Everyday Discrimination Scale: This short 6-item measure asks about self-reported discrimination 
experienced by participants in their day-to-day lives. The first section asks about the frequency of this 
discrimination using a Likert-style scale from 1-6 with lower scores indicating a higher frequency of 
discrimination. The second section asks participants to think about the reasons why they may be 
experiencing this discrimination. This measure takes about 3 minutes to complete. 
• 
Tobacco Use History Questionnaire: This questionnaire assesses a variety of current and past smoking 
behaviors, including periods of non-smoking. It also assesses other tobacco/nicotine product use besides 
cigarettes. This measure takes approximately 10 minutes to complete. 


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• 
Fagerström Test for Nicotine Dependence (FTND): A scaled 6-item measure for assessing the severity 
of nicotine dependence. We will complete this at baseline and at monthly follow-ups. This measure takes 
approximately 2 minutes to complete. 
• 
Smoking Cessation Therapies Questionnaire: This questionnaire asks about past and current (past 30 
days) use of smoking cessation therapies such as NRT and medications. This measure takes about 2 
minutes to complete. 
• 
Stages of Change Questionnaire: Also known as “The Contemplation Ladder,” this brief survey assesses 
the participant’s readiness to quit smoking and their confidence in quitting. It takes approximately 2 minutes 
to complete. 
• 
Barriers to Study Participation Survey: This 15-item survey asks about participants’ barriers to 
participating in research studies. It takes approximately 5 minutes to complete. 
• 
Health Changes Questionnaire: This questionnaire is designed to assess any changes in health since 
the participants’ last study visit. It assesses changes in health condition, medications, and asks if there 
have been any adverse events. It takes approximately 3 minutes to complete. 
• 
Internet/Smartphone Access and Use Survey: An 11-item questionnaire assessing technology access 
and use. We will ask about previous experience with smartphones, as well as information on smartphone 
ownership. We will only ask this during the baseline session. This measure takes approximately 3 minutes 
to complete. 
• 
Timeline Follow-Back: This measure quantifies the substances a subject has used in a certain period of 
time. It utilizes a calendar format and key events to record substance use. In our trial, we will specifically be 
asking about cigarette consumption, smoking abstinence, NRT usage, and Antiretroviral Therapy (ART) 
adherence. Depending on the timeframe of the assessment, the measure takes about 10 minutes to 
complete. 
• 
Smoking Abstinence Survey: This is a brief 12-item questionnaire designed to assess current smoking or 
non-smoking behavior, including quit attempts and periods of abstinence. It also includes questions about 
NRT use. This measure takes approximately 3 minutes to complete. 
• 
Systems Usability Scale: A 10-item questionnaire, measuring various metrics of usability of a design 
using a 5-point Likert Scale. We complete these with subjects at each follow-up. This measure takes 
approximately 2 minutes to complete. 
• 
Research Participant Perception Survey: Questionnaire used to assess the research participation 
experiences of participants to help the research team potentially improve the experience of clinical trial 
research participants. We are using a shortened 13-item version of the original 77-item measure. Research 
staff will provide the survey to the participant at the end of their study participation. Participants will enter 
this information in directly in order to avoid social desirability effects. This measure takes approximately 2 
minutes to complete. 
 
 


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6.0. Study Procedures 
6.1. Recruitment 
Participants (n=60) will be recruited through similar channels as those from the user-centered design study: 
patient referrals from other HIV research studies and from Duke clinics (i.e., infectious disease clinic). 
Participants will be instructed to contact the lab phone or email to learn more about the study. We will also 
recruit potential participants through Duke's electronic health record (EHR) in order to expand our recruitment 
pool. We will use Maestro Care and DEDUCE to identify potentially eligible Duke patients that meet the age, 
smoking, and HIV inclusion criteria. 
In addition, we will recruit participants from other external community clinics in the Triangle area. We will 
provide clinics with advertising materials such as flyers and handouts to give to potentially interested patients. 
Patients will be instructed to contact the research team for more information. As this is a completely remote 
study, we may also recruit through online advertisements (e.g. Facebook, Craigslist). Finally, we may also use 
research study repositories such as ResearchMatch.org to recruit potentially eligible candidates. 
Research staff will phone screen each potential participant to see if they meet primary eligibility for the study 
(see section 2.1 “Inclusion Criteria”). If participants are eligible after the phone screen, they will be invited to 
attend a remote screening session via Zoom video call. If they are not eligible following the phone screen, they 
will be transferred to other CfAST studies for which they may be eligible (if they desire), or directed towards 
local quitting resources. If potential participants are unsure about whether or not they’d like to participate after 
the screening phone call, they will be encouraged to take as much time as they need to think it over before 
getting back to research staff about participation. However, they will need to be re-phone screened if there is a 
substantial amount of time (i.e., greater than 1 month) between the original phone screen and the participant’s 
contact as their eligibility to participate may have changed. 
6.2. Screening Visit 
Participants will receive a Zoom video call via email link prior to their visit. We will also send instructions on 
how to join the Zoom call, and tell participants to call research staff if they are experiencing any technical 
difficulties. They will be instructed to join the call at the time of their visit. Once on the call, staff will give the 
participant a brief reminder of the study purpose. Then, staff will email a REDCap survey link to the participant 
to read and sign an electronic consent form. After reviewing the form, and before signing, the research staff 
member will display a PowerPoint presentation that outlines everything in the consent form (responsibilities, 
risks, benefits, compensation, etc.). After the presentation, the participant will electronically sign and complete 
the consent form if they choose to participate. They will be officially enrolled in the study, and will be assigned 
a subject ID number. If they do not want to participate anymore after going through the consent form or 
presentation, they will be thanked for their time and be given quitting resources. 
After signing the consent form, participants will complete the following measures: 
(1) Demographics and Identifying Information Form 
(2) Medical eligibility to participate 
a. Brief Medical History Questionnaire and BMHQ Follow-Up (if applicable) to assess medical 
compatibility with NRT treatment and involvement with HIV treatment 
b. Filling out Concomitant Medications (“con meds”) form (if applicable) 


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c. Completing Release of Information Form to communicate with providers 
d. COVID-19 & Quitting Smoking Questionnaire – Screening Version 
(3) Psychiatric assessment 
a. Drug Abuse Screening Test (DAST) and Alcohol Use Disorders Identification Test (AUDIT) 
to assess current problematic behaviors related to drug and alcohol use 
b. Drug Use Questionnaire (12+1 Month) to assess current and past drug use 
c. Mini International Neuropsychiatric Interview (MINI) 
d. Columbia Suicide Severity Rating Scale (C-SSRS) to assess any current suicidality 
(4) HIV-related stigma 
a. Stigma Mechanisms Scale and Everyday Discrimination Scale to determine perceived HIV- 
and smoking-related stigma 
(5) Smoking status 
a. Tobacco Use History and Exposure questionnaire to evaluate smoking status and past and 
current tobacco use 
b. Smoking Cessation Therapies questionnaire 
c. Stages of Change questionnaire (Contemplation Ladder) to evaluate interest in quitting 
smoking 
(6) Barriers to Study Participation survey 
At the end of the session, participants will be compensated for their time and told that we will review their 
eligibility with the PI and study doctor, and get back to them to schedule their baseline session. All participants 
are compensated regardless of final eligibility. The baseline session will occur within 30 days of consent, 
otherwise we will have to re-screen the participant. 
Following the screening session, all information will be given to the study doctor to determine medical eligibility 
to participate (i.e., medical compatibility with NRT). The PI will then make the final decision about the 
participant’s eligibility. If not eligible, participants will be notified and referred to other research studies and/or 
quitting resources. If deemed eligible, research staff will reach out to schedule a baseline session during which 
the participant will be randomized to the intervention. 
6.3. Baseline Visit 
Participants will attend a Zoom baseline session following their eligibility determination to be randomized to the 
intervention. A few measures will be completed prior to randomizing the participant: 
(1) Health Changes questionnaire (adverse event and con med forms filled out if applicable) 
(2) COVID-19 & Quitting smoking Questionnaire (Adapted) 
(3) Assessing psychiatric functioning 
a. Depression Anxiety Stress Scale-21 (DASS-21) 
b. C-SSRS 
c. Brief Symptom Inventory (BSI) 
(4) Fagerström Test for Nicotine Dependence (FTND) 
(5) Timeline Follow-Back (TLFB) Questionnaire 
(6) Drug Use Questionnaire (1 Month) 
(7) Internet/Smartphone Access and Use survey 
After completing these measures, the participant will be randomized. They will receive either the LTQ-H app, or 
a standard-of-care app called QuitGuide developed by the National Cancer Institute (NCI). The RA will instruct 


10 
 
 
 
the participant on how to download their assigned app from the App Store/Google Play Store. The RA will give 
a brief overview of the assigned app to discuss the main functions and troubleshoot any major issues that may 
arise. They will also instruct the participant to enter their unique tracking code (similar to their subject ID) to 
allow us to track their background analytics data. 
Following the baseline visit, we will mail 8 weeks of NRT patches to participants. We will tell participants to 
call/email the study team to confirm that they received their NRT. We will then instruct participants to start 
using the patches on the day of their quit date, which will be within 4 weeks of the baseline visit. Participants 
will be oriented on the best practices of using NRT based on the package instructions. There will be a brief 
compliance review session following the instructions in order to ensure that patients understand how to use the 
medication. 
  6.4. Follow-Up Visits 
Participants will complete monthly follow-up (FU) visits at Weeks 4, 8, and 12 weeks post-randomization. All 
visits will be conducted via zoom video calling. 
At each visit, participants will complete surveys to assess their smoking behavior, changes in physical or 
mental health (which will prompt staff to assess for adverse events), and user experience with their assigned 
study app. See table below for a list of all the measures. 
At each visit, research staff will conduct an interview with the participant to ask about their experience using 
their assigned app. This interview will be audio recorded for later review. Each FU visit is expected to last 
between 45-60 minutes, depending on the assessment burden. 
Measure 
Week 4 
Week 8 
Week 12 
Biochemical Verification (CO) 
 
 
x 
Health Changes Questionnaire 
x 
x 
x 
Adverse Events and Con Meds (if applicable) 
x 
x 
x 
COVID-19 & Quitting Smoking Questionnaire (Follow-up) 
x 
x 
x 
Drug Use Questionnaire (1 Month) 
x 
x 
x 
Timeline Follow-Back 
x 
x 
x 
DASS-21 
x 
x 
x 
BSI 
x 
x 
x 
Systems Usability Scale (SUS) 
x 
 
x 
Qualitative user experience interview 
x 
 
x 
Research Participant Perception Survey (RPPS) 
 
 
x 
Participants who self-report smoking abstinence by the final follow-up visit (FU3) will be mailed an iCO 
smokerlyzer device to do a breath test in order to biochemically verify abstinence. We will mail these to 
participants following their FU3 session. Once they receive the device, we will set up a short Zoom call to walk 
them through the CO breath test process. Staff will be on the call in order to ensure that it is the participant 


11 
 
 
 
who is doing the test, and that they are doing the test properly. Once the participant completes the test, we will 
ask them to email the result of their test to our lab email. Participants will keep these devices once they are 
completed in the study. The stop date for these participants will be the date of this breath test instead of the 
date of the FU3 visit. 
Background analytics will be collected throughout the 4 months of participation, and will be measuring some 
things such as CPD, mood ratings, NRT use, duration of app use, and number of interactions within the app. 
At the final visit (Week 12), participants will be given quitting resources if they have not quit. They will also be 
referred to other research studies, if eligible and willing. 
6.5. Compensation 
Participants will be compensated for their participation in the trial. Participants can earn up to $130 for 
completing all study activities. Compensation amounts are determined based on the burden of the research 
activities at the time point, as well as the length of the visit. Compensation will be provided on a Duke ClinCard 
that will be given out at the screening visit. Any withdrawn participants will be compensated for any research 
activities that were completed. In addition to monetary compensation, participants will be given an 8-week 
supply of NRT patches free of charge. 
Assessment Time Point 
Compensation Amount 
Screening 
$15 
Baseline 
$15 
Week 4 
$20 
Week 8 (Via telephone) 
$30 
Week 12 
$50 
Total $130 
7.0. Participant Safety 
7.1. Risks & Benefits 
Nature and degree of risk 
The anticipated physical, psychological, social, or legal risks of this study are minimal. The possible side 
effects of using NRT include skin irritation at site of patch placement, insomnia, rapid heart rate, dizziness, 
nausea, and diarrhea. As in all studies (including qualitative interviews), there is the possibility of unauthorized 
disclosure of confidential information. Dr. Vilardaga (one of the MPIs) is a licensed clinical psychologist and 
can use his clinical judgment to assess how much risk a participant may be put in by doing this interview. The 
participant could also experience discomfort or embarrassment related to their ability to use a mobile app or 
smartphone device. 
Minimizing risk of harm and protecting participants’ rights and welfare 
To address the possible side effects from Nicotine Replacement Therapy (NRT) patches, we will have our 
study doctor, Dr. Paolo Mannelli, available to monitor and evaluate participants’ use of NRT in addition to 
consulting with the research team. We will also emphasize the package instructions’ directions of placing the 
NRT patch in varying locations, and replacing the patch every morning to reduce possible skin irritation. The 


12 
 
 
 
research team will monitor use of the NRT as well as review any reported changes in medications by the 
subject throughout the course of their participation. 
Potential participants will be screened to eliminate candidates with disorders or conditions that are 
contraindicated with the intervention (see section 2.1), or those who are not able to provide informed consent. 
We will work to coordinate the subject’s participation in the study with the medical/mental health care that they 
are already receiving by obtaining a written Release of Information (ROI) that will allow research staff to 
communicate with their providers throughout the study. 
The research team will be sensitive to issues surrounding confidentiality and other forms of participant risk by 
taking steps to maintain confidentiality and reduce the risk of unauthorized disclosure of subject data. For 
instance, we will use a research subject identification number (subject ID) as the identifier for research data 
rather than using personally identifiable information (PII), and any forms/data containing PII will be stored 
separate from research data. We will emphasize the confidential nature of the data collected in this trial, 
explaining our safeguarding procedures to potential and enrolled research subjects. We will note which de-
identified data will be shared, and how we work to ensure its security. 
If at any time a participant expresses discomfort over any aspect of the study procedures, the research team 
member may discontinue the distressing activity.  
Possibility of discovering a subject’s previously unknown condition 
We will use a set of safety procedures to ensure safe participation during the research trial. The research team 
has medical personnel on staff nearby (i.e. Duke University Medical Center) that are available to deal with any 
unforeseen medical complications that may arise.  
The research team will assess medical and psychiatric safety, treatment compliance, and data completion for 
each subject. We will deal with psychological problems or distress should it arise. If necessary, we will contact 
patients’ providers using a ROI to connect them with the patient in distress. 
Consistent monitoring of participant progress provides one level of safety procedures. Another level of safety 
procedures involves evaluation of data collected (especially items related to aggression/suicidality in the BSI) 
and of verbal reports of suicidal and/or homicidal intent to staff members. All reports of suicidal or homicidal 
ideation will be immediately reported to the PI as well as to the patient’s treating clinician. All research staff will 
receive training in identifying suicide/homicide risks and/or signs of dangerous intoxication and in following the 
steps needed to appropriately respond to these signs. 
Participants judged by study investigators at any point to be a danger to self or others or who are judged to be 
in grave danger due to continued drug use and/or to medical/psychiatric problems will be discontinued from the 
study but actively connected with their treating clinician. 
Anticipated benefits of research on individual subjects 
Participants might benefit from the study by quitting smoking. We will provide free nicotine replacement therapy 
patches to participants, and the monitored use of the smoking cessation apps may contribute to cessation. 
Anticipated benefits of research on society, benefits outweighing risks 
Smoking directly causes 480,000 deaths a year in the United States. The prevalence of smoking among PLWH 
is disproportionately high (42-43%) as compared to the U.S. general population (15%). Increased longevity 
among PLWH—due to the development of highly effective treatments for HIV infection—has resulted in PLWH 
losing more years to smoking than to HIV infection itself. 


13 
 
 
 
Information derived from the study could help improve the effectiveness and reach of smoking cessation 
treatments for PLWH. This may benefit society and other clients of treatment programs. Participants in the 
study may see improvement in the physical, psychological, occupational, familial, and economic problems 
associated with their tobacco cessation. 
The interviews proposed in this research may guide the development of tools to treat tobacco addiction in this 
population. Given that levels of access to mental health providers depends on geographical location, this study 
may help develop low-cost and high-reach smoking cessation tools for PLWH in areas where there may be few 
or lacking smoking cessation services (e.g., rural areas). Therefore, the minimal risks to participants are 
reasonable in relation to the anticipated benefits. 
7.2. Adverse Event Collection & Reporting 
Anticipated events 
Given that many people who are HIV+ and smokers have more medical needs than the general population, we 
do anticipate subjects will report a higher rate of Adverse Events (AEs) as an inherent characteristic of this 
population. These include such events as COPD, lung cancer, pneumonia, psychiatric symptoms, and 
Antiretroviral Therapy medication side effects. 
Some anticipated AEs resulting from the study interventions include study drug side effects. The study drug 
(i.e. NRT) has some common side effects that we expect subjects to occasionally report, including: dizziness, 
headaches, rapid heart rate, increased blood pressure, nausea and diarrhea. For the nicotine patch in 
particular, common side effects include skin irritation and/or itching where the patch is placed, insomnia, and 
vivid dreaming. 
In addition, quitting smoking can result in withdrawal symptoms that may be uncomfortable to the participant. 
Common withdrawal symptoms include: cravings for cigarettes; depressed or sad mood; insomnia or trouble 
sleeping; feeling irritable‚ on edge‚ or grouchy; trouble concentrating; restlessness; decreased heart rate; and 
increased appetite/weight gain. 
There may be some risks associated with smartphone and app usage. Events that we anticipate subjects may 
report to us around using the study smartphone include sleep disturbances (from high frequency use), eye 
strain (from viewing the screen), and data breaches (if subjects enter their personal information in the phone).  
Collecting and recording AEs 
We will be tracking all AEs and serious adverse events (SAEs) that a participant may experience once starting 
the study intervention (from Baseline onward). We will be doing this throughout the study, regardless of 
whether or not we think they are related to the study intervention. AEs will be documented by research 
personnel during research assessments, or at any other time during the clinical trial that they have contact with 
or about the subject. The PIs and study doctor are responsible for oversight on AEs. 
We will document each AE with details such as: 
• 
Description of event; 
• 
Start and stop dates (if applicable); 
• 
Whether or not they are getting treated (e.g. medications or therapies); 
• 
Whether or not it is considered an SAE; 
• 
Any other pertinent details. 
Collected AEs will be documented and recorded with the information above on AE forms and entered into an 
electronic database (i.e., REDCap). On a weekly basis, the PI will review each AE to determine the following: 


14 
 
 
 
• 
Relationship to the study intervention; 
• 
Severity of the event; 
• 
Outcome; 
• 
Status: ongoing, closed, lost to follow-up; 
• 
Deciding what course of action should be taken to address the AE. 
The PI may consult with the study physician if needed.  
If the participant reports a SAE, the same collection and recording procedures will take place as with AEs. 
However, research staff will alert the PI to the SAE as soon as possible (within 24 hours of a reported SAE). 
The PI will review the reported SAE within 24 hours of becoming aware of it. SAEs will have a separate form 
completed for each one that’s reported.  
8.0. Data Analysis and Sample Size 
8.1. Determination of Sample Size 
Given that this is primarily a feasibility and acceptability trial, we expect the intervention effect sizes to have 
notable variance (i.e., wide confidence intervals), thus the relevance of the current study is linked to its 
significance and potential impact to the field, and not on its ability to estimate parameter estimates in the 
population. In this scenario, a precision (rather than power) approach is especially suited, since calculating 
confidence intervals is ideal for preliminary or pilot investigations, and facilitates that sample size is determined 
by practical rather than formal considerations. Given that retention is a key issue in smoking cessation studies, 
we will focus on this primary outcome. A pilot study of LTQ and prior studies in the general population of ACT-
based interventions for smoking cessation show 93% 6-month participant retention, and 70% for standard of 
care.  
Further, with 30 participants per group, we calculated that we would have 70%, 75% and 80% power to detect 
abstinence rates of 0.32, 0.34, and 0.36 effect sizes, respectively.  
8.2. Data Analysis 
Primary feasibility outcomes include: 
• 
Recruitment rates and participant retention;  
• 
App engagement (frequency and duration of app use) 
We will report on recruitment rates and participant retention descriptively. Trajectories of app engagement will 
be plotted to examine ongoing interactions with the app and duration of app use per day.  
Primary acceptability outcomes include: 
• 
App usability (System Usability Scale); 
• 
User experience (semi-structured interviews); 
Acceptability outcomes will be evaluated descriptively with summary scores of the SUS. Scores above the 
SUS threshold (>68) are considered optimal. User experience will be extracted via Thematic Analysis of 
transcripts of semi-structured interviews.  
Secondary outcome measures include: 
• 
Change in cigarettes smoked per day (CPD) (measured daily with the tracking feature embedded within 
each app) 


15 
 
 
 
• 
Quit attempts (self-reported no smoking at all for 24 hours—and time to 7-day relapse will assessed via 
a Timeline Follow Back interview at Weeks 4, 8, and 12) 
• 
7-day point prevalence abstinence (not smoking even a puff of a cigarette within the last 7 days) and 
breath CO<5 ppm at Weeks 4, 8, and12) 
• 
Adherence to NRT (measured via app tracking feature and Timeline Follow-Back interview at Weeks 4, 
8, and 12) 
• 
Participant safety (adverse events) 
Differences between treatment groups (LTQ-H vs. NCI QuitGuide) in terms of secondary outcomes will be 
assessed via chi-square tests and logistic regression or t-tests and linear regression, as appropriate: 
Chi-square tests and logistic regression: 
• 
Quit attempts (prevalence of any quit attempts, yes/no) 
• 
7-day point prevalence abstinence (prevalence of any verified abstinence, yes/no) 
• 
Adherence to NRT (prevalence of use of optimal amount of NRT, yes/no) 
• 
Participant safety (prevalence of any adverse events, yes/no) 
t-tests and linear regression: 
• 
Change in CPD (measured as a continuous variable) 
• 
Quit attempts (total number of quit attempts, measured as a continuous variable) 
• 
Adherence to NRT (overall % of NRT used as directed, measured as a continuous variable) 
• 
Participant safety (total number of adverse events, measured as a continuous variable) 
 
 


16 
 
 
 
Appendix 
List of Abbreviations 
ROI – Release of information 
ICF – Informed consent form 
Con meds – Concomitant medications 
AE – Adverse event 
SAE – Serious adverse event 
CO – Carbon monoxide 
BAL – Breath alcohol level 
BP – Blood pressure 
HR – Heart rate 
NRT – Nicotine replacement therapy 
LTQ-H – Learn to Quit-HIV 
QG – QuitGuide 
NCI – National Cancer institute 
RA – Research assistant 
CPD – Cigarettes-per-day 
UE – User engagement 
UX – User experience 
CfAST – Center for Addiction Science and Technology 
PLWH – Persons living with HIV 
RCT – Randomized controlled trial 
PPM – Parts per million 
PII – Personally Identifiable Information 

ICF_000.pdf: 
 
Informed Consent Form 
 
 
 
 
 
Official Title:  
                      Early-phase Studies of a Tailored Evidence-Based Smoking Cessation 
mHealth App for Persons Living with HIV 
 
Identifiers: NCT04609514 
Document Version: 03/25/2022  
 
 
 
 
 
 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 2 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
You are being asked to take part in this research study because you are an every day smoker with 
HIV/AIDS over the age of 18. Research studies are voluntary and include only people who choose to 
take part.  Please read this consent form carefully and take your time making your decision. As your 
study doctor or study staff discusses this consent form with you, please ask him/her to explain any words 
or information that you do not clearly understand.  We encourage you to talk with your family and 
friends before you decide to take part in this research study.  The nature of the study, risks, 
inconveniences, discomforts, and other important information about the study are listed below. 
 
Please tell the study doctor or study staff if you are taking part in another research study. 
 
A grant from the National Institutes of Health (NIH) will sponsor this study. Portions of Dr. Roger 
Vilardaga’s and his research team’s salaries will be paid by this grant. 
 
WHO WILL BE MY DOCTOR ON THIS STUDY? 
If you decide to participate, Dr. Paolo Mannelli will be your doctor for the study and will be in contact 
with your regular health care provider throughout the time that you are in the study and afterwards, if 
needed. He will be available to the research team to consult on any medical concerns and respond to any 
emergency arising from the study procedures.  
 
WHY IS THIS STUDY BEING DONE? 
The purpose of this study is to test the: (1) feasibility (is it possible for PWH to use this app to quit 
smoking?), (2) usability (do PWH find this app easy to use?), and (3) preliminary efficacy (does this app 
work in helping PWH quit smoking?) of a novel smoking cessation smartphone app for people with HIV 
(PWH) called “Learn to Quit-HIV,” or “LTQ-H” for short. This app is investigational, meaning it is still 
being tested in research studies and its effectiveness is not yet known. 
 
CONCISE SUMMARY 
The purpose of this research study is to test the feasibility, acceptability, and preliminary efficacy of a 
novel smoking cessation smartphone application (app) for people with HIV (PWH). This study consists of 
5 study visits that will take about 12 weeks (or about 3 months) to complete.  
 
If you are eligible to participate, you will be assigned to one of two smoking cessation apps and asked to 
use it for the next 3 months. You will receive an 8-week course of nicotine replacement therapy (NRT) 
patches. During the study visits, you will also complete questionnaires and be interviewed about your 
experience using the app. 
 
The biggest risks of participating in this trial are withdrawal symptoms if you stop smoking, side effects 
from NRT, and possible loss of privacy/confidentiality. 
 
If you are interested in learning more about this study, please continue reading below. 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 3 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
The Learn to Quit app was developed by Dr. Roger Vilardaga, Principal Investigator. Currently, this app 
is not available to the public, and is only available to you as a participant in this study. It is owned by 
Duke University and the University of Washington, as it was developed and tested in both institutions. If 
the technology is commercially successful in the future, the developers and these two universities may 
benefit financially. We will be comparing the LTQ-H app with another app created by the National 
Cancer Institute (NCI) for the general public called “QuitGuide”, which was not developed by the 
research team. 
 
Findings from this research will help the study team develop a finalized version of this app which will 
then be tested for efficacy in a larger sample of smokers living with HIV. 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
Approximately 60 people will take part in this study at Duke University Medical Center. 
 
WHAT IS INVOLVED IN THE STUDY? 
This study will be completely remote. All five visits will be done over Zoom video calling. We will 
provide you with a link to the Zoom call prior to each of your study visits. We ask that during your 
scheduled visit you find a quiet, private place to talk with us, as we will discuss some sensitive topics. 
 
Screening Visit 
After reading through this consent form and going over a brief PowerPoint Presentation, you will be 
asked to sign and date this consent form if you agree to participate. You will then complete the 
following procedures to make sure that you are eligible:  
• Giving the study team your personal and contact information 
o Demographics questionnaire 
o Filling out a Release of Information (ROI) form that will allow us to communicate with 
your healthcare provider throughout your study participation 
• Completing questionnaires 
o Medical history questionnaire 
o Psychiatric assessment questionnaires 
o Questionnaires related to smoking status 
o Questions about your experience living with HIV 
 
Following the screening visit, the study team will review your eligibility to participate in the study. Once 
we determine this, we will contact you to let you know of your eligibility status. If you are eligible, we 
will schedule your next visit. 
 
Baseline Visit 
If you pass these initial screening measures, you will be contacted by study staff to schedule a baseline 
session. During this visit, we will: 
• Complete more questionnaires about your mental and physical health 
• Ask about your smoking status since your last visit 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 4 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
• Ask you to complete a survey about your internet and smartphone use 
 
You will then be randomly assigned (like the flip of a coin) to receive either LTQ-H or a comparator app 
(QuitGuide). You have a 1 in 2 (50%) chance of receiving either app. All participants will receive an 8-
week course of nicotine replacement therapy (NRT) patches regardless of app assignment. Study staff 
will instruct you on how to download your assigned app onto your smartphone, then give you a brief 
overview of the app including how to use the app’s basic functions. During this visit, we will also ask 
you to pick a quit date prior to your next study visit (within 4 weeks of receiving the app). 
 
After the baseline visit is completed, we will mail your 8-week supply of NRT patches. We ask that you 
contact us when you get your NRT in the mail, and then we will go over the instructions on how to use 
the NRT patches properly. We will ask you to keep your used NRT patches for counting at each follow-
up visit. At the follow-up visits, we will count both the used and unused patches to see how many you 
have used since your last visit. 
 
Follow-Up Visits 
After completing the baseline visit, we will schedule you for 3 monthly Follow-Up sessions where you 
will complete more assessments. The visits will occur 4 weeks (FU1), 8 weeks (FU2), and 12 weeks 
(FU3) after the baseline visit. You will complete the following measures at the follow-up visits: 
• Questionnaires about your mental and physical health 
• Questionnaires about your smoking/quitting status 
o Using a calendar to recall how many cigarettes you smoked in the past month and how 
often you used NRT 
• Questionnaires about your assigned app 
• Being interviewed by research staff about your experience using your assigned app  
o This portion of the visit will be audio recorded 
 
If you have quit smoking by the last follow-up session (FU3), you will be mailed a small device that 
measures the amount of CO in your lungs by giving a breath sample. If you are told to do a breath test, 
we will provide detailed instructions on how to do so. We will also ask you to complete the breath test 
over a Zoom call with research staff to ensure that you are using the device correctly, and to record the 
result of your CO breath test. Once you successfully complete this CO test, you will get to keep the 
device. 
 
We will also be collecting background analytics about your app engagement throughout your time in the 
study. This includes how often you use the app, and what app features you use. The study app is the only 
app for which we will collect this data; we will not be tracking your smartphone use or any of the other 
apps that you use. Since the LTQ-H app is not yet publicly available, we will have you delete the app 
from your phone at the end of the study. If you are assigned to QuitGuide, you can keep the app on your 
phone if you choose but request for you to delete your subject ID number off the app since we will no 
longer be collecting data from you. 
 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 5 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
HOW LONG WILL I BE IN THIS STUDY? 
Study participation is 12 weeks (or about 3 months) long. 
 
You can choose to stop participating at any time without penalty or loss of any benefits to which you are 
entitled. However, if you decide to stop participating in the study, we encourage you to talk to your  
treatment provider first. If you choose to withdraw, you will be asked to complete a termination visit, 
return any unused NRT and delete the app and/or your subject ID from the phone. 
 
WHAT ARE THE RISKS OF THE STUDY? 
Physical Side Effects: As a result of your participation in this study, you are at risk for the following 
side effects. You should discuss these with the study doctor and your regular health care provider if you 
choose.  
 
Nicotine Replacement Therapy (NRT): NRT patches may cause some, all, or none of the side-effects 
listed below: 
• Itchy or irritated skin where the patch is placed 
• Insomnia, vivid dreams 
• Dizziness, lightheadedness 
• Rapid heart rate, increased blood pressure 
• Nausea 
 
Nicotine Withdrawal Symptoms: Quitting smoking cigarettes may also cause mild symptoms called 
withdrawal symptoms. Though these feelings can be uncomfortable, they are of minimal risk. Common 
withdrawal symptoms include: 
• Cravings for cigarettes 
• Feeling irritable, on edge, or grouchy 
• Having trouble concentrating 
• Feeling down or sad 
• Restlessness 
• Feeling hungrier than usual 
We will be monitoring these symptoms throughout your participation in the study. If we think that 
participating in the study is putting your health at risk, we may have to withdraw you from the study. 
Reproductive Risks: 
For women: Smoking is associated with an increased risk of bad outcomes in pregnancy, including 
miscarriage, preterm birth, and stillbirth. Although nicotine replacement therapy is sometimes used to 
help pregnant smokers quit, the changes your body undergoes during pregnancy could affect your 
response to the other interventions in the study. Women who are pregnant or planning a pregnancy 
during the next 6 months are not allowed to participate in the study. 
 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 6 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
You and your partner should use effective methods of contraception to avoid pregnancy during the 
study. These methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices, 
(d) barrier methods (condoms, diaphragms, cervical caps) plus spermicide, or (e) hormonal methods 
(birth control pills, implants, injections, patches, vaginal rings). Depending on your age and other 
medications you may be taking, some of these methods may not be appropriate. Your study doctor will 
review your birth control method with you to make sure it is appropriate and meets the requirements of 
this study. Because no birth control method is 100% effective, you should notify your study doctor 
immediately if you think there is any chance you could be pregnant.  
Loss of Privacy/Confidentiality: The research team will be taking very careful steps to ensure your 
information remains strictly confidential. All study files are kept in locked filing cabinets in locked 
offices. All digital data is stored on secured Duke School of Medicine servers. However, there is always 
the possibility there may be an unauthorized disclosure of your personal information. 
 
Uncomfortable or Embarrassing Tasks: You may be asked to answer questions and do tasks that may 
cause discomfort or embarrassment, including: 
• Answering questions about your medical history, psychiatric symptoms, and HIV status 
• Answering questions about your familiarity with technology 
• Using a smartphone and app, which could be embarrassing if you are not familiar with this 
technology 
You may skip a question you do not wish to answer; however, not answering certain questions could 
affect your eligibility to participate in the study. You may stop the interview at any time, and you may 
do so without penalty. 
 
Video/Audio Recordings: We will be audio and video recording your user experience interviews at 
FU1 and FU3. All of these recordings will be stored securely on DUHS servers. If you are concerned 
about being video recorded, you may turn your video off during the recording portion of each visit. 
 
Audio recordings are only reviewed by the research team and a contracted transcription service. All 
audio recordings will only be labeled by your participant ID number, and will not contain any 
information that can identify you unless you explicitly share that information in the audio recording. At 
your request, you may: 
• Review the audio recording of your interview 
• Stop the recording at any time 
• Ask that portions of the recording (or the entire thing) be erased 
 
Mobile Phone Risks: Jailbreaking (rooting) of smart devices poses a serious security risk and is not 
allowed as stated in the Secure System Usage Memo (http://security.duke.edu/policies-procedures). 
 
Information collected by mobile applications or ‘apps’ is subject to their terms of use, which you should 
read carefully.  Many apps make claims that they are very secure, compliant with federal privacy  


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 7 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
regulations, and used and tested by other academic centers. However, any mobile app that is 
downloaded carries potential security risks, and Duke cannot guarantee that these mobile apps are free 
of risk.  Some apps may be able to perform hidden functions or may have security flaws that allow 
unauthorized access to information. We are unable to fully tell you what information these mobile apps 
are able to access or change on your device (phone/tablet) or what information from your device may be 
stored outside of Duke. You are encouraged to limit personal identifiers you enter into mobile 
applications (particularly your name, date of birth, address, place of employment, and other details that 
could allow someone to identify you) only to those that you wish to voluntarily share with others.   
These apps may send/receive information with other mobile apps, including social networking apps or 
websites (for example, Facebook). If you give permission for this, the terms of use for those 
apps/websites apply and you should read them carefully.  
 
It is recommended that you run a current operating system (OS) on your device, review the 
privacy/security settings often, and restrict any unnecessary access.  These applications may run in the 
background of your device.  Mobile apps may have unanticipated impact on the operations of your 
device (e.g., battery drainage).   If you do not have an unlimited data/text plan, you may incur additional 
charges.   At the conclusion of the study, we will provide you instructions on how to remove the mobile 
apps from your device.  
 
We are not asking you to make any health decisions based on the use of these mobile apps. You should 
discuss health decisions directly with your healthcare provider. 
 
As with all technology, we ask you to wait until you are in a safe environment, use good judgment and 
follow prevailing laws. Do not perform study-related activities while you are driving. 
 
Drug and Food Interactions: For your safety, you must tell the study doctor or nurse about all the 
prescribed medical foods and drugs, herbal products, over-the-counter (OTC) drugs, vitamins, natural 
remedies, and alcohol that you are taking before you start the study and before starting to take any of 
these products while you are on the study. 
 
There may be risks, discomforts, drug interactions or side effects that are not yet known. 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
The apps and study medication (NRT) you receive in this study may assist you in quitting smoking. 
Apps and study interventions are provided at no charge to you. We hope that the information learned 
from this study will help us develop a finalized version of the LTQ-H app which may help many more 
smokers living with HIV quit smoking. 
 
WHAT ALTERNATIVES ARE THERE TO PARTICIPATION IN THIS STUDY? 
You do not need to participate in this study to get help to quit smoking. If you decide that you do not 
wish to be a part of the study, the research team will assist you in finding other services or resources that  
 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 8 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
may be available to you. This may include other popular smoking cessation smartphone apps, and 
recommendations for NRT use. 
 
Please talk to your doctor about these and perhaps other options. 
 
WILL MY INFORMATION BE KEPT CONFIDENTIAL? 
Participation in research involves some loss of privacy. We will do our best to make sure that 
information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal 
information may be viewed by individuals involved in this research and may be seen by people 
including those collaborating, funding, and regulating the study. We will share only the minimum 
necessary information in order to conduct the research. Your personal information may also be given out 
if required by law.  
 
As part of the study, results of your study-related laboratory tests and procedures may be reported to The 
National Institutes of Health and its affiliates. In addition, your records may be reviewed in order to 
meet federal or state regulations. Reviewers may include representatives and affiliates of The National 
Institutes on Drug Abuse, the Duke University Health System Institutional Review Board, and others as 
appropriate. If any of these groups review your research record, they may also need to review your 
entire medical record. 
 
The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to 
further protect your privacy. With this Certificate, the investigators may not disclose research  
information that may identify you in any Federal, State, or local civil, criminal, administrative, 
legislative, or other proceedings, unless you have consented for this use. Research information protected 
by this Certificate cannot be disclosed to anyone else who is not connected with the research unless:   
1) There is a law that requires disclosure (such as to report child abuse or communicable 
diseases but not for legal proceedings);  
2) You have consented to the disclosure, including for your medical treatment; or  
3) The research information is used for other scientific research, as allowed by federal 
regulations protecting research subjects.  
Disclosure is required, however, for audit or program evaluation requested by the agency that is funding 
this project or for information that is required by the Food and Drug Administration (FDA). 
You should understand that a Confidentiality Certificate does not prevent you or a member of your 
family from voluntarily releasing information about yourself or your involvement in this research. If you 
want your research information released to an insurer, medical care provider, or any other person not 
connected with the research, you must provide consent to allow the researchers to release it. This means 
that you and your family must also actively protect your own privacy. 
Finally, you should understand that the investigator is not prevented from taking steps, including 
reporting to authorities, to prevent serious harm to yourself or others. 
The study results will be retained in your research record for at least six years after the study is 
completed. At that time either the research information not already in your medical record may be  


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 9 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
destroyed or information identifying you will be removed from such study results at DUHS. Any 
research information in your medical record will be kept indefinitely. 
This information may be further disclosed by the sponsor of this study.  If disclosed by the sponsor, the 
information is no longer covered by federal privacy regulations. If this information is disclosed to 
outside reviewers for audit purposes, it may be further disclosed by them and may not be covered by 
federal privacy regulations. 
 
While the information and data resulting from this study may be presented at scientific meetings or 
published in a scientific journal, your name or other personal information will not be revealed. 
 
Some people or groups who receive your health information might not have to follow the same privacy 
rules. Once your information is shared outside of DUHS, we cannot guarantee that it will remain private. 
If you decide to share private information with anyone not involved in the study, the federal law 
designed to protect your health information privacy may no longer apply to the information you have 
shared.  Other laws may or may not protect sharing of private health information. 
 
WHAT ARE THE COSTS TO YOU? 
If you agree to be in the study, there are no direct costs to you. However, smartphone usage may use 
some of your cellular data if you are not on WiFi while using the app.  
The study team will provide NRT patches free of charge to you. At the end of the study, or if you decide 
to withdraw from the study before it ends, you may be asked to return all unused study drug. 
 
WHAT ABOUT COMPENSATION? 
You will be reimbursed up to $130 for your expenses related to your participation. If you decide to 
withdraw from the study, you will be compensated for the study activities that you do complete. The 
compensation scheme for the study is shown below. 
 
Assessment Time Point 
Compensation Amount 
Screening 
$15 
Baseline 
$15 
Week 4 
$20 
Week 8 (Via telephone) 
$30 
Week 12 
$50 
Total $130 
 
WHAT ABOUT RESEARCH RELATED INJURIES? 
Immediate necessary medical care is available at Duke University Medical Center in the event that you 
are injured as a result of your participation in this research study. However, there is no commitment by 
Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary 
compensation or free medical care to you in the event of a study-related injury. 
 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 10 of 11 
Subject*Initials_________ 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
 
For questions about the study or research-related injury, contact either one of the Principal Investigators: 
• Dr. Roger Vilardaga at 919-681-3441 during regular business hours and at 775-303-2103 after 
hours and on weekends and holidays 
 
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE 
STUDY? 
You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the 
study at any time. If you withdraw from the study, no new data about you will be collected for study 
purposes unless the data concern an adverse event (a bad effect) related to the study.  If such an adverse 
event occurs, we may need to review your entire medical record.  All data that have already been 
collected for study purposes, and any new information about an adverse event related to the study, will 
be sent to the study sponsor.   
 
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of 
benefits to which you are entitled, and will not affect your access to health care at Duke. If you do 
decide to withdraw, we ask that you contact the research team to let them know that you wish to 
withdraw from the study. You will be asked to complete a termination visit where we will ask you to 
return any unused NRT, and delete the app off your phone. 
 
We will tell you about new information that may affect your health, welfare, or willingness to stay in 
this study. 
 
The study doctor may decide to take you off this study if your condition gets worse, if you have serious 
side effects, or if they determine that it is no longer in your best interest to continue.  The sponsor or 
regulatory agencies may stop this study at any time without your consent. If this occurs, you will be 
notified and your study doctor will discuss other options with you. 
 
The use of your data may result in commercial profit. You will not be compensated for the use of your 
data other than what is described in this consent form. 
 
A description of this clinical trial will be available on https://clinicaltrials.gov/ as required by U.S. Law.  
This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
For questions about the study or a research-related injury, or if you have problems, concerns, questions 
or suggestions about the research, contact either one of the Principal Investigators: 
 
• Dr. Roger Vilardaga at 919-681-3441 during regular business hours and at 775-303-2103 after 
hours and on weekends and holidays 
 


Consent to Participate in a Research Study 
Pilot Study of a Tailored Evidence-Based Smoking Cessation  
mHealth App for People with HIV (PWH) 
 
Page 11 of 11 
* 
DUKE UNIVERSITY HEALTH SYSTEM 
Form 
M0345 
Name: ________________________ 
 
 
DOB: _________________________ 
For questions about your rights as a research participant, or to discuss problems, concerns or suggestions 
related to the research, or to obtain information or offer input about the research, contact the Duke 
University Health System Institutional Review Board (IRB) Office at (919) 668-5111. 
 
STATEMENT OF CONSENT 
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I 
have been allowed to ask questions, and my questions have been answered to my satisfaction. I have 
been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to 
the research, or to obtain information or offer input about the research. I have read this consent form and 
agree to be in this study, with the understanding that I may withdraw at any time.  I have been told that I 
will be given a signed and dated copy of this consent form." 
 
 
__________________________________________ 
 
___________     ____________ 
Signature of Subject  
 
 
 
 
 
Date 
 
   Time 
 
 
 
__________________________________________ 
 
___________     ____________ 
Signature of Person Obtaining Consent 
 
 
 
Date 
 
   Time