Clinical trial NCT03999411
Conditions: Smoking Smoking Cessation HIV
Keywords: nicotine replacement therapy antiretroviral smartphone
Sponsor: University of Miami
Start date: 2019-09-09; Completion date: 2020-10-14
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.

Detailed description:
The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).

Arms: arm 1: Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART. arm 2: Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls. arm 3: Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.
Interventions: intervention 1: Nicoderm C-Q Transdermal Product intervention 2: Adherence to Antiretroviral Therapy Counseling intervention 3: Behavioral Smoking Cessation Counseling intervention 4: "Crave-to-Quit" app intervention 5: vDOT "emocha" app
Intervention descriptions: intervention 1: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT) intervention 2: Brief counseling on adhering to antiretroviral therapy with self-help materials. intervention 3: One time face-to-face smoking cessation counseling and 2 follow-up phone calls. intervention 4: Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention. intervention 5: Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.

Protocol documents:
Prot_001.pdf: 
 
Study Title: A Novel smartphone-based intervention to support 
smoking cessation and adherence to antiretroviral therapy among 
people living with HIV: A pilot randomized clinical trial  
 
UM IRB Study Number: 20190181 
 
Clinical Trials Registration #: NCT03999411 
 
Date: 06/29/2020


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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1) Protocol Title 
 
A Novel smartphone-based intervention to support smoking cessation and 
adherence to antiretroviral therapy among people living with HIV: A pilot 
randomized clinical trial 
 
2) Objectives* 
 
Our proposed study aims to:  
 
1. We will conduct 3-arm pilot randomized controlled trial (RCT) to test the 
feasibility, acceptability, and potential efficacy of a combined intervention 
consisting of an evidence-based MT smoking cessation app “Crave-to-Quit” with 
vDOT app “emocha” to improve ART adherence among PLWHIV smokers; and 
  
2. We will conduct a post-intervention process evaluation consisting of semi-
structured interviews with select participants to fine-tune the intervention based 
on feedback from participants for further testing in Phase II large-scale RCT. 
 
Findings will inform a larger study of the effectiveness of cessation approaches 
with great potential for translation and dissemination to PLWHIV smokers 
throughout the US.  
 
 
3) Background* 
 
PLWHIV are at high risk for tobacco-related health disparities. Smoking prevalence in 
PLWHIV is triple that of the general population (47% - 65% vs. 17%, respectively).1-4 
Most PLWHIV smokers are members of marginalized groups (e.g., ethnic minorities, 
migrants, men who have sex with men),4 unemployed, and have low social support.5 
Compared to nonsmokers, PLWHIV smokers have threefold the risk of cancers,6 double 
the risk of cardiovascular complications,7 a 6 to 15 years shorter lifespan,8 and lower self-
reported quality of life.9 In contrast, smoking cessation among PLWHIV reduces the risk 
of cardiovascular disease by 20%, non-AIDS malignancy by 34%, and overall mortality 
by 16%.10 There is also an unmet need to develop innovative smoking cessation 
interventions for PLWHIV that can: 1) increase their access to treatment, 2) address their 
unique psychosocial profile, and 3) address the intersection between smoking and 
adherence to ART. 
 
Two systematic reviews conclude that Smartphone-based Smoking Cessation 
Applications (Apps) are effective and significantly increase access to treatment.19,20 In 
addition to their high potential for dissemination, smartphone apps provide a promising 


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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medium to deliver an intervention due to their availability, relatively low cost, and ease 
of use. Compared to in-person treatment, this approach can be standardized, reduce 
stigma associated with seeking treatment, allow the use of multiple methods to deliver the 
intervention (e.g., video, audio), facilitate the integration of the treatment into user’s daily 
life, help tracking user’s progress 24/7, and simultaneously boosting user’s engagement, a 
strong predictor of smoking cessation.21-24  
 
Depression and craving are two major predictors of smoking relapse in PLWHIV.28 
Depression among PLWHIV is up to three times higher than that in the general 
population.29,30 In addition, smoking cessation is a major life stressor and is strongly 
linked with psychological stress, depression, and negative and positive affect that can 
lead to relapse.31,32 One promising strategy for smoking cessation in PLWHIV is 
Mindfulness Training (MT). MT proved to be effective in reducing both self-report and 
objective indices of negative affect and psychological stress.33,34 MT also can help 
smokers control craving by being less emotionally reactive and less prone to relapse 
related to avoidance of distressing symptoms.35 In PLWHIV, MT was feasible and 
effective at improving quality of life, aging, emotional well-being, immunological status, 
and coping with HIV.38 Yet, MT for smoking cessation in this population has not been 
implemented or tested.  
 
Based on the social cognitive theory, self-monitoring is a key component of self-
management because it gives patients insight into the dynamic relationship between 
triggers and the target behavior at the time and in the context in which they occur.39 
Tracking ART intake while quitting smoking can help individuals self-monitor their 
compliance to treatment, identify triggers to noncompliance, and ultimately improve their 
adherence to treatment. Video Directly Observed Therapy (vDOT) of patients taking their 
medications has become a cornerstone to improve adherence to treatment in several 
diseases (e.g., tuberculosis). Emocha Mobile Health Inc. has recently developed an app 
“emocha” that uses vDOT following the CDC protocol to improve medication 
adherence.40 Several studies have shown that “emocha” can secure medication adherence 
rates of 90-95%.41,42 Recently, Dr. Judson Brewer developed an evidence-based 
mindfulness smoking cessation app “Crave-to-Quit” adapted from an in-person MT 
relapse prevention smoking cessation intervention that proved to be effective in the 
general population.43-47 Building on his work, and using a mixed-method approach of 
quantitative and qualitative research, we propose to: 1) test the feasibility, acceptability, 
and potential efficacy of a combined intervention consisting of an evidence-based MT 
smoking cessation app “Crave-to-Quit” with vDOT app “emocha” to improve ART 
adherence in a pilot randomized clinical trial (RCT) among PLWHIV smokers; and 2) 
fine-tune the intervention based on feedback from participants for further testing in Phase 
II large-scale RCT. 
 
 
4) Inclusion and Exclusion Criteria* 
Those eligible for inclusion area those who:  


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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 ≥ 18 years old,  
 have been prescribed ART medication in the prior 6 months 
 have smoked ≥ 5 cigarettes/day in the past year 
 be interested in making a quit attempt in the next 30 days 
 own a smartphone (apple/android), and plan to keep it active for the next 3 
months 
 read/speak English 
 be able to provide consent 
 have no plans to move in the next 3 months 
 not pregnant or planning to be pregnant in the following 3 months 
 
We will not include any of the following groups: 
 Adults unable to consent 
 Individuals who are not yet adults (infants, children, teenagers) 
 Pregnant women 
 Prisoners 
 Have contraindication to NRT (past month myocardial infarction, 
history of serious arrhythmias/or unstable angina pectoris, 
dermatological disorder),63 
 Currently being treated for a psychiatric condition. 
 Currently being treated for smoking cessation, alcoholism, or illicit drug 
use 
 
 
5) Procedures Involved* 
 
Aim 1: The Clinical Trial 
 
We will be provided with a list of potentially eligible participants including their names, 
contact information, smoking status, most recent HIV-1 viral load (VL), CD4 count, ART 
regimen history (e.g., time since first starting ART, current prescription) from the UM 
HIV Registry (pls. see LOS from Dr. Safren; their IRB # is pending approval of this 
protocol). This will include HIV Registry participants who have previously given consent 
to be contacted for future research studies. Eligible participants will be contacted by 
phone and invited to participate in the study. Those who are interested will be screened. 
Those who are eligible will be scheduled to attend the orientation session. Those who are 
not eligible, or decline to participate will be encouraged to quit smoking and given a list 
of available resources. We will additionally recruit participants at HIV community health 
centers in Miami. The process here will be the same, where interested participants will be 
screened for eligibility and scheduled for an orientation session. 
 
Breath carbon monoxide (CO) (for cotinine analysis) will be collected at baseline for 
participants to confirm their smoking status. The breath sample will be collected with a 
portable CO monitor (Micro CO™ by Micro Direct, Inc.). Cut-offs of < 8 ppm for CO 


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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and <10 ng/ml for cotinine will be used to determine smoking status (Benowitz et al 
2002). 
 
Participants will be assigned to blocks, based on gender. Then, within each block, 
participants will be randomly assigned to one of three treatment arms:  
 
1. Usual Care (UC)/control: Participants in this group will receive a brief advice to 
adhere to ART, a brief advice to quit smoking, 6-week supplies of NRT, and self-help 
materials to quit smoking and adhere to ART. 
 
2. Only smoking cessation intervention (Crave-to-Quit app): This intervention is based 
on the theory of mindfulness-based cognitive therapy (MBCT) for relapse prevention.64 
The MBCT uses cognitive behavioral therapy methods in collaboration with MT 
techniques. Cognitive methods focuses on the development of personal coping strategies 
that target solving problems and changing unhelpful patterns in cognitions (e.g. thoughts, 
beliefs), behaviors, and emotional regulation.65 MT focus on becoming aware of all 
incoming thoughts and feelings and accepting them, but not attaching or reacting to 
them.36 This process is known as "Decentering" and aids in disengaging from self-
criticism and rumination that can arise when reacting to negative thinking patterns.66 
Participants in this group will receive the UC for adherence to ART, one in-person 
orientation sessions, 6-week supplies of NRT, the “Crave-to-Quit” app, and two brief 
follow-up phone calls.  
 
Orientation session. This session will occur 3 weeks before quit date and will last for 90 
min. During the session, a research associate will explain the purpose, format, and 
procedures of the study.  Participants will then watch a video that explains the specifics 
of their respective arm’s study activities; there will be a different video for each of the 3 
arms. After the video the research associate will go through the written informed consent, 
have the participant sign, and have the participant complete the baseline assessment. 
Then, participants will be instructed to download on their phone the “Crave-to-Quit” app 
and will receive a tutorial explaining the app content and features to troubleshoot any 
issues, followed by training on how to use the app and to practice MT techniques 
introduced in the app. Participants will be instructed to start using the app , and the app 
will assign a quit date within the next 3 weeks. Participants will receive 6 weeks of 
NRT,63 and will be instructed to start using the NRT at the quit date. Orientations and 
collection of consent may be conducted individually or in groups, according to 
participants’ schedules. 
 
The Crave-to-Quit app. The app is comprised of 22 modules for 22 days, 5–15 minutes 
each, designed to teach MT using audio, video, and animation.44 Participants have access 
to only one new module per day, and subsequent days are locked to prevent skipping 
ahead (pls. see LOS from Ms. Roman from MindSciences). The app teaches three basic 
formal MT techniques including Body Scan (bringing awareness to different parts of the 


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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body to foster awareness of body sensations that constitute cravings and affective states), 
Loving-Kindness (repeating phrases such as "may X be happy” to foster acceptance of 
oneself and others), Breath Awareness (paying attention to the breath wherever one feels 
it most strongly in the body to help retrain the mind away from habitually engaging in 
self-related thinking toward a more present-centered awareness), and one informal MT 
RAIN (Recognize, Accept, Investigate, and Note what cravings feel like as they 
arise/pass away). In RAIN, participants are asked to identify their smoking trigger, rate 
their craving, and choose between using RAIN to ride out their craving, or completing an 
audio-guided exercise to ‘smoke mindfully’ by paying attention to the moment-to-
moment experience and bodily sensations of smoking. The app also includes other 
features such as social support (quit friend sign-ups, the tip of the week), activity feed (to 
track interaction with the app), and my morning stats (to track smoking).  
 
Two brief follow-up phone calls. The first phone call will occur one day before the quit 
date to remind participants about their quit date and provide support. The second will 
occur at the end of treatment (6 weeks after quit date) to review progress, provide 
support, and schedule the 3-month follow-up visit.  
 
3. The combined intervention (Crave-to-Quit + emocha apps): In addition to the 
intervention in the second group, participants in this group will be instructed during the 
Orientation Session to download on their phone the emocha app and will receive a 
tutorial explaining the app content and features. The study team will explain to 
participants that the app will help them in tracking dose-by-dose medication adherence by 
recording a video for themselves taking their medication. Participants will be instructed 
to find a private place to take their medication, make sure their face is well lit when 
recording, have a clear glass of water, state their name, the date, and each medication as 
they take it, display their medication pills, show medication in the mouth before 
swallowing, drink water, show open mouth after swallowing, and repeat the same 
procedure every time they take the medication. During the 3-month trial, our staff will 
have full access to the app’s web portal to navigate and collect information about 
patients’ adherence to ART (pls. see LOS from emocha Mobile Health Inc.). 
 
At the orientation session, participants will complete a baseline assessment consisting of: 
  
 Demographics and HIV history. Age, race/ethnicity, sexual orientation, 
relationship status, education, employment, income, time since HIV diagnosis, and 
HIV 1 RNA VL (from medical chart), ART regimen history, time since first 
starting ART, current ART prescription,72 VAS for adherence to ART.61,62 
 Smoking. Smoking history, past quit attempt, motivation to quit, confidence in 
quitting, Fagerström test for nicotine dependence,73 12-item smoking self-efficacy 
to resist urge to smoke,74 and 15-item Minnesota nicotine withdrawal scale (i.e., 
craving, irritability, anxiety, depression).75  


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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 Mindfulness skills: The five facet MT questionnaire that measures MT skills 
related to observing, describing, acting with awareness, non-judging of inner 
experience, and non-reactivity to inner experience.76  
 Others. The 10-item Centers for the Epidemiologic Study of Depression (CES-D) 
scale,77 social support,78 quality of life,79 and alcohol and substance use 
(ASSIST).80 
 
 
Participants will receive $50 for completing the baseline assessment. 
 
All participants will receive one in-person follow-up assessment at 3 months after 
enrollment to assess their smoking status and adherence to ART as well as get 
information about concomitant smoking and NRT use, use of additional NRT or 
cessation drugs (e.g., bupropion), and use of other tobacco methods. Breath CO (for 
cotinine analysis) will be collected at the 3-month follow-up points for participants who 
report abstinence. The breath sample will be collected with a portable CO monitor (Micro 
CO™ by Micro Direct, Inc.). Cut-offs of 8 ppm for CO and 10 ng/ml for cotinine will be 
used to determine abstinence (Benowitz et al 2002).  
 
The following will be assessed at the three-month intervention: 
 All baseline assessments except demographics. 
 Usability and engagement. The absolute number of times logged into the apps 
will be calculated for each user to obtain the mean number of using each app. 
Two items also will be assessed “self-reported number of completed days for each 
app,” and level of comfort with the app “I am comfortable using the app.” 
Participants in Arms 2 & 3 will also complete The System Usability Scale (SUS) 
at call 1 & 2 and the 3-month follow-up to evaluate the overall usability of and 
satisfaction with the app (John Brooke, 1986). 
 Acceptability. The acceptability will be assessed by 3 items “How satisfied were 
you with the intervention?”, “How likely are you to recommend this intervention 
to a friend?” and “How useful was the intervention?”  
 Feasibility. We will monitor rates of recruitment and effort required (e.g. number 
of staff hours) as well as the number of screenings conducted, proportion eligible, 
and proportion who agree to enroll. Feasibility of recruitment will be 
operationalized as an enrollment rate of 70% or higher (an established standard in 
the RCT literature). We will also record number of rescheduled, cancelled, and 
missed assessment visits as well as received visits/calls in each treatment arm to 
inform estimation of staffing needs and retention protocols for a planned efficacy 
RCT. Other outcomes are rate of attrition (not having a final visit at the end of 
treatment), rates of several categories of attrition (mortality, withdrawal from the 
study, transfer to non-study clinics, loss to follow-up without identifiable cause), 
and response rates to questionnaires (operationalized as 70% or higher), 
adherence/compliance rates (operationalized as completing at least 70% of the 
app’s module in arm 2 & 3), and time needed to collect and analyze data.  


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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 Smoking Cessation. Main Smoking cessation outcome is 7-day point-prevalent 
abstinence (defined as self-report of not smoking in the past 7-days; not even a 
puff) confirmed by breath CO cotinine level of < 10 ng/ml at the 3-month follow 
up. Secondary outcome is the reduction in number of cigarettes smoked per 
day.81,82 Relapse is defined as smoking at least once/week on two consecutive 
weeks.83 Adherence to ART. >95% adherence to ART (using VAS).70  
 
Participants will receive $50 for completing the three-month assessment. 
 
As an evaluation of the feasibility of the app-based intervention, we will call participants 
in Arms 2 & 3 once a week for 3 weeks  to ask a brief set of questions about their 
mindfulness practice and use and opinions of the app. Participants will receive $5 per 
each of these 3 calls they complete (for a total of up to $15). From these two arms, we 
will randomnly select 6 participants that will be asked to complete daily, instead of 
weekly calls, for a period of 3 weeks; they will  receive $5 per each call for a total of up 
to $105 ( $5 per call x 21 calls). 
 
We will use Google Voice to communicate with participants via text for reminders (ex: 
appointments scheduled, using the apps on schedule, phone call reminders, follow-up 
reminders). These texts will not mention “HIV”, only that it is part of a research study. 
 
Aim 2. Post-intervention Process Evaluation  
 
After the intervention, in-person semi-structured post-intervention evaluation interviews 
will be conducted with participants from the “Crave-to-quit + emocha” and “only crave-
to-quit” groups  to further inform our assessment of acceptability and perceived 
helpfulness of interventions, and identifying key areas for refining the intervention 
protocols (e.g., improving access, content, usability). Participants will receive a $50 
incentive for participating. This interview will be audio-recorded and transcribed and 
may take place the same day of the 3-month follow up visit or on a separate date. 
 
 
6) Data and Specimen Banking* 
 
7) Data Management* 
Participant paper assessments will be stored in a locked filing cabinet in CRB 942. Data 
from the surveys will be entered into and stored in REDCap, accessed only by approved 
study personnel. Data will be downloaded and entered into a statistical software program 
for analysis. Audio files and transcripts from the post-intervention evaluation will be 
saved in Box and accessed only by approved study personnel. 
 
8) Risks to Subjects* 
The risks associated with participating in this study are those related to answering basic 
questions about demographic characteristics and smoking behaviors. Participants will be 


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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assured that their data and any audio recordings will be kept confidential and that they are 
free to not answer any questions.  
 
9) Potential Benefits to Subjects* 
Participants may be able to quit smoking through use of the intervention in the 
study. 
 
10) 
Vulnerable Populations* 
Those with HIV. 
 
11) 
Setting 
The study will take place at the Don Soffer Clinical Research Center, the  
Infectious Disease Research Unit, and Miami HIV community health centers. 
 
12) 
Resources Available 
The PI of the study, Dr. Taghrid Asfar, has many years’ experience in conducting 
tobacco control studies. Dr. Lee is also specialized in tobacco control. Dr. 
Alcaide, the Director of the UM HIV Research Unit in the Department of 
Infectious Diseases, has expertise in HIV research, and will assist in coordinating 
recruitment.  
 
13) 
Prior Approvals 
Letters of Support from Drs. Safren at the UM HIV Registry and Dr. Alcaide 
from the Behavioral CFAR Core are attached. 
 
14) 
Recruitment Methods 
We are collaborating with Drs. Safren (the Director of the UM HIV Registry) and 
Alcaide (Co-I; the Director of the UM HIV Research Unit) to recruit those who were 
identified as smokers in their database and have agreed to participate in future research 
(pls. see LOS from Drs. Safren and Alcaide). We will be provided with a list of potential 
participants including their names, contact information, smoking status, most recent HIV-
1 viral load (VL), and ART regimen history (e.g., time since first starting ART, current 
prescription). This will include HIV Registry participants who have previously given 
consent to be contacted for future research studies. Eligible participants will be contacted 
by phone and invited to participate in the study. Those who are interested will be 
screened. Those who are eligibility will be scheduled to attend the orientation session. 
Those who are not eligible, or decline to participate will be encouraged to quit smoking 
and given a list of available resources. We will additionally recruit participants at HIV 
community health centers in Miami. The process here will be the same, where interested 
participants will be screened for eligibility and scheduled for an orientation session. 
 
 
15) 
Local Number of Subjects 
We will recruit up to 75 participants. 


IRB Study Number: 20190181 
Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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16) 
Confidentiality 
All participant data will be stored in a locked cabinet or in REDCap and accessed 
only by approved study personnel.  Their name will be replaced with an ID 
number on their survey data and a key linking the two will be available only to 
approved research personnel and only for purposes of contacting them as needed 
in the study. Their name will not be associated with interview transcripts. Audio 
files from the interviews and electronic files such as verbal consents will be stored 
in Box and accessed only by approved study personnel.  
 
17) 
Provisions to Protect the Privacy Interests of Subjects 
Participants can be assured that the personal information they provide will only be 
seen by approved research staff and they will not be identified in any publication.  
 
18) 
Consent Process 
We will obtain verbal consent over the phone to participate and be scheduled for 
an orientation session by a research associate. We will obtain written consent 
from participants at the orientation session to participate in all study activities 
including phone calls, the 3-month follow-up visit and the post-intervention visit. 
We will obtain a separate audio/video consent form at the orientation session as 
well so we may record the study visits.  
 
 
 
 
 
 


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Clinical Trials Registration #: NCT03999411 
Date: 6/29/20 
 
 
 
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