Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women
Phase: NA
Conditions: Smoking, Smoking Cessation
Sponsor: University of Vermont

Title: Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska 
Native Pregnant Women 
NCT Number: not yet assigned 
Document Date: July 29, 2021 
 

Page 1 of 31 
 
Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska 
1 
Native Pregnant Women 
2 
 
3 
Project Leaders: 
4 
 
5 
Diann Gaalema, PhD 
6 
Project Principal Investigator 
7 
Vermont Center on Behavior and Health 
8 
Departments of Psychiatry and Psychological Science, University of Vermont 
9 
 
10 
Kaitlyn Browning, PhD 
11 
Project Postdoctoral Fellow & Primary Project Contact 
12 
Vermont Center on Behavior and Health 
13 
Departments of Psychiatry and Psychological Science, University of Vermont 
14 
 
15 
Stephen Higgins, PhD 
16 
Center Principal Investigator 
17 
Vermont Center on Behavior and Health 
18 
Center of Biomedical Research Excellence 
19 
Departments of Psychiatry and Psychological Science, University of Vermont 
20 
 
21 
Kathy Koller, PhD 
22 
Site Principal Investigator 
23 
Alaska Native Tribal Health Consortium (ANTHC), Anchorage, AK 
24 
 
25 
Key Personnel: 
26 
Diann Gaalema, PhD, Vermont Center on Behavior and Health, University of Vermont 
27 
Stephen Higgins, PhD, Vermont Center on Behavior and Health, University of Vermont 
28 
Allison Kurti, PhD, Vermont Center on Behavior and Health, University of Vermont 
29 
Kathy Koller, PhD, ANTHC 
30 
Timothy Thomas, MD, ANTHC 
31 
Christi Patten, PhD, Mayo Clinic (Rochester, MN) 
32 
Steven Steinhubl, MD, ANTHC 
33 
Christine Hughes, Mayo Clinic (Rochester, MN) 
34 
Norman Medina, BBA, Vermont Center on Behavior and Health, University of Vermont 
35 
Carolyn Evemy, BA, Vermont Center on Behavior and Health, University of Vermont 
36 
Kaitlyn Browning, PhD, Vermont Center on Behavior and Health, University of Vermont 
37 
 
38 
Summary: 
39 
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, 
40 
growth retardation, other adverse fetal and infant health problems, and later-in-life chronic 
41 
conditions among exposed offspring.  The most effective intervention for reducing smoking 
42 
during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, 
43 
cash) contingent on objective evidence of smoking abstinence.  However, financial incentives-
44 
based interventions are typically delivered in relatively intense protocols requiring frequent 
45 
clinic visits, which limits the geographical range over which services can be delivered and 
46 

Page 2 of 31 
 
potentially denies treatment to those residing in remote or otherwise difficult to reach settings.   
1 
 
2 
Dr. Steve Higgins, PhD and Dr. Allison Kurti PhD, are investigators at the University of 
3 
Vermont conducted a pilot clinical trial that examined the feasibility, efficacy, and cost-
4 
effectiveness of a smartphone-based financial incentives intervention whereby smoking 
5 
monitoring and delivery of incentives were completed remotely using a mobile app (DynamiCare 
6 
Rewards, designed by DynamiCare Health, Inc.).  For this pilot trial, pregnant women were 
7 
recruited via obstetrical clinics and WIC offices in Vermont, as well as Facebook ads deployed 
8 
nationally.  Eligible participants who completed the informed consent process were assigned to 
9 
one of two conditions: an incentives condition wherein women receive financial incentives 
10 
contingent on the remote submission of breath and saliva specimens indicating abstinence from 
11 
recent smoking (described below), or a best practices control condition in which women receive 
12 
usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief 
13 
educational sessions and referral to their state quit line by our research staff.  Data from the this 
14 
trial were promising, with participants in the Best Practices plus Incentives condition 
15 
demonstrating over three-fold higher quit rates at late pregnancy (~37%) versus Best Practices 
16 
participants (~11%). Dr. Higgins and Dr. Kurti are currently conducting a larger-scale version of 
17 
this clinical trial.  
18 
 
19 
One group that is not currently being reached by this highly promising intervention approach are 
20 
Alaska Native women.  Thus, the proposed study seeks to examine the preliminary feasibility 
21 
and efficacy of this remote, smartphone-based incentives intervention among 60 Alaska Native 
22 
pregnant women who are current cigarette smokers. 
23 
 
24 
For inclusion in the study, Alaska Native women must meet the following criteria: (a) > 18 years 
25 
of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report 
26 
smoking in the 7 days prior to completing their eligibility screening, (d) < 25 weeks pregnant, (e) 
27 
speak English, (f) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 
28 
[2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a 
29 
smartphone).  Exclusion criteria include: (a) current or prior mental or medical condition that 
30 
may interfere with study participation (assessed via self-report during eligibility screening), (b) 
31 
smoke marijuana more than once each week and not willing to quit (marijuana smoking can 
32 
inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), 
33 
and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, 
34 
buprenorphine).   
35 
 
36 
Participants randomized to the Best Practices plus Incentives condition will select a quit date 
37 
(either the first or second Monday following their enrollment), and will submit videos of 
38 
themselves blowing into a breath CO monitor twice daily during week 1.  They will receive 
39 
incentives for every sample where expired breath CO is < 6 ppm.  Beginning in week 2 and 
40 
extending through week 6, participants will submit videos twice per week (Monday/Thursday) 
41 
for which they will receive incentives for providing videos of themselves completing saliva 
42 
cotinine tests indicating smoking abstinence.  From week 7 until delivery, participants will 
43 
submit videos once per week and will continue to receive incentives for saliva cotinine tests 
44 
indicating no smoking.  During the postpartum period, women will submit videos twice weekly 
45 
for the first 4 weeks and once weekly from weeks 5-12.  The first negative breath CO or salivary 
46 

Page 3 of 31 
 
cotinine sample is worth $6.25 and each consecutive negative sample will increase the value of 
1 
the incentive by $1.00 up to a maximum of $33.25 per sample.  Missed samples or samples that 
2 
indicate smoking will be worth $0 and will reset the incentive at its starting value (i.e., $6.25).  
3 
However two consecutive negative samples following the slip will restore the incentive to its 
4 
value before the slip.  The maximum earnings in this condition is $1,620, which is the same as 
5 
our prior studies adjusting for inflation.  A proposed incentive schedule is attached. 
6 
 
7 
Women in both conditions will complete seven formal assessments of their smoking status 
8 
during their participation (intake, early pregnancy or 1 month after enrollment, late pregnancy or 
9 
> 28 weeks gestation, and at 4-, 8-, 12-, and 24-weeks postpartum) along with a treatment 
10 
acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment 
11 
engagement.  Women will receive $50 for completing each of these ($350 total). 
12 
 
13 
As the proposed study is the first examination of smartphone-based financial incentives for 
14 
reducing smoking during pregnancy among Alaska Native women, it represents an exploratory 
15 
study, thus power analyses were not conducted to select the sample size.  However, a sample of 
16 
60 Alaska Native women (30 Best Practices plus Incentives, 30 Best Practices) is consistent with 
17 
prior pilot studies on this treatment conducted at the University of Vermont (Higgins et al., 2004; 
18 
Kurti et al., 2020).  This sample size will be sufficient to detect significant differences in 
19 
smoking abstinence at participants’ late pregnancy assessment, and results of this pilot study will 
20 
be used to inform power analysis calculations in larger grant applications.  
21 
 
22 
Participants will be recruited from online media outlets (i.e., Facebook) targeting Alaska Native 
23 
pregnant women.  Recruitment materials that we propose posting online are attached.  We have 
24 
also attached the battery of questionnaires that we propose administering at formal assessments, 
25 
the Research Information Sheet that we will read to participants over the phone to obtain verbal 
26 
consent to participate in the study, as well as the full consent form that we will mail to them after 
27 
obtaining their verbal consent to participate. 
28 
 
29 
 
30 
PURPOSE AND OBJECTIVES 
31 
 
32 
Purpose 
33 
Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the 
34 
U.S. and other developed countries, increasing risk for pregnancy complications, preterm birth, 
35 
stillbirth, infant death, impaired lung development, childhood illness and 
36 
developmental/behavioral problems, and lifelong increased risk for cardiovascular disease, 
37 
obesity, and metabolic syndrome.1-8  Prevalence of smoking during pregnancy among national 
38 
samples of U.S. pregnant women has remained stagnant at approximately 13% over the past 
39 
decade.9-10  Because risk for maternal smoking during pregnancy is disproportionately high 
40 
among economically disadvantaged women, it contributes substantially to the problem of health 
41 
disparities.11-12 Importantly, smoking prevalence is particularly high among Alaska Native 
42 
women (i.e., ~ 36% (Patten et al. 2018) versus ~ 13% among U.S. pregnant women overall 
43 
(Kurti et al., 2017).  Alaska Native women also exhibit unique tobacco use characteristics 
44 
including use of a homemade smokeless tobacco (Iqmik, Hurt et al., 2009), and very few 
45 

Page 4 of 31 
 
smoking cessation interventions have been implemented specifically among Alaska Native 
1 
women (Patten et al., 2010; Patten et al., 2018).   
2 
 
3 
Existing treatments for smoking cessation among pregnant smokers produce very low quit rates 
4 
(< 15%) with the exception of financial incentives.  Meta-analyses indicate that incentive-based 
5 
treatments produce the largest effect sizes of any psychosocial or pharmacological intervention 
6 
for promoting smoking cessation during pregnancy.13-14  Additionally, two randomized, 
7 
controlled trials conducted by the University of Vermont (UVM) demonstrated that incentives 
8 
significantly increase sonographically estimated fetal growth, increasing abdominal 
9 
circumference (cm/week), femur length (cm/week), and overall estimated fetal weight compared 
10 
to control groups that received non-contingent incentives.15  Retrospective analyses of birth 
11 
outcome data aggregated across three previous trials from UVM also indicated that incentives 
12 
significantly increased mean birth weight, decreased the percent of low birth weight deliveries (< 
13 
2500 g), increased the percent of women breastfeeding through 12-weeks postpartum, and 
14 
decreased depressive symptoms from birth through 12-weeks postpartum among depression-
15 
prone women.16-18  Although this evidence-based treatment has demonstrable capacity to reduce 
16 
smoking and improve birth outcomes, the scalability of this approach is constrained by the 
17 
frequent clinic visits necessary for biochemical verification of smoking status, which limits 
18 
access to those in the immediate vicinity of clinics that can provide such care.  Capitalizing on 
19 
technological advancements may surmount such access barriers, with the potential to extend 
20 
the reach of financial incentives to disadvantaged pregnant smokers nationwide.    
21 
 
22 
The overarching aim of the parent study is to develop an innovative, efficacious, remotely 
23 
delivered financial incentives intervention to reduce cigarette smoking during pregnancy.  
24 
Pilot data from a sample of 60 pregnant women recruited nationally (30 Best Practices plus 
25 
Incentives vs 30 Best Practices) yielded promising results (Kurti et al., 2020).  In brief, it was 
26 
feasible to recruit and retain pregnant smokers in this smartphone-based smoking cessation pilot 
27 
study, and smartphone-based financial incentives produced significantly higher quit rates during 
28 
pregnancy and postpartum relative to controls. The proposed study seeks to examine the 
29 
feasibility and efficacy of this treatment strategy among Alaska Native women, who were not 
30 
included in completed pilot study or in the larger clinical trial led by Dr. Higgins and Dr. Kurti 
31 
that is currently underway. 
32 
 
33 
To enable flexible use of the intervention in diverse locations, we use a mobile-phone-based 
34 
platform for delivering the incentives intervention.  The platform involves a Smartphone “app” 
35 
(DynamiCare Rewards) which uses video capture to verify smoking status via a breath carbon 
36 
monoxide (CO) monitor along with saliva cotinine test kits, and ensures treatment fidelity by 
37 
providing automated, immediate feedback, incentive calculations, and incentive delivery for 
38 
abstinence.  Comparable technology-based treatment delivery platforms have been used to 
39 
successfully promote smoking abstinence among the general population of U.S. smokers and 
40 
among other vulnerable populations including rural heavy smokers.20   
41 
 
42 
The proposed pilot study addresses the following specific aims among Alaska Native women: 
43 
 
44 
Aim 1:  Examine the feasibility, efficacy, and cost-effectiveness of a mobile-phone-based 
45 
incentives intervention for promoting smoking cessation among Alaska Native pregnant women.  
46 

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We will accomplish this aim by randomly assigning 60 pregnant women who smoke to receive 
1 
best practices for promoting smoking abstinence plus incentives contingent on biochemically 
2 
verified smoking abstinence or best practices alone.  Incentives will be in place from the start of 
3 
study enrollment through three months postpartum.  Primary outcomes will be point prevalence 
4 
smoking abstinence and continuous abstinence during and following pregnancy.  We hypothesize 
5 
that there will be higher abstinence rates and longer durations of abstinence in the best practices 
6 
plus incentives versus the best practices control condition.  
7 
 
8 
Aim 2:  Evaluate acceptability of the treatment, including barriers to and facilitators of treatment 
9 
engagement.  We will accomplish this aim by assessing treatment enrollment and retention and 
10 
conducting semi-structured interviews with participants upon treatment completion.  During 
11 
these interviews, participants will be queried about their perceived utility of the incentives for 
12 
promoting health-related behavior change, and other barriers and facilitators of treatment 
13 
engagement and success (e.g., social support networks).21-22  Qualitative research methods will 
14 
be used to discern general themes.     
15 
 
16 
Overall, this project has the potential to address disparities in access to efficacious, evidence-
17 
based smoking cessation treatments among Alaska Native pregnant women.  If the present 
18 
mobile-phone-based incentives intervention is acceptable and efficacious in this population, this 
19 
study will provide strong preliminary data for a future R01 proposal to facilitate more 
20 
widespread dissemination of this innovative treatment model among Alaska Native communities. 
21 
 
22 
Objectives: 
23 
 
24 
The primary objective is to examine the feasibility, efficacy, and cost-effectiveness of a mobile-
25 
phone-based incentives intervention for promoting smoking cessation among Alaska Native 
26 
pregnant women.   
27 
 
28 
The secondary objective is to evaluate the acceptability of the treatment, including barriers to 
29 
and facilitators of treatment engagement. 
30 
 
31 
 
32 
METHODS AND PROCEDURES 
33 
 
34 
Study Design: 
35 
We are proposing a two condition, parallel groups, randomized controlled pilot study of a 
36 
mobile-phone-based financial incentives intervention targeting Alaska Native pregnant cigarette 
37 
smokers.  The experimental group will receive financial incentives (i.e., money loaded onto a 
38 
debit card) contingent on the remote submission of breath carbon monoxide (CO) and saliva 
39 
cotinine samples indicating smoking abstinence in addition to best practices for promoting 
40 
smoking cessation. The control group will receive best practices alone.  The use of a best 
41 
practices control group reflects a real-world comparison condition in that all women will receive 
42 
the treatment that practitioners in the community are instructed to provide (i.e., the 5As plus quit-
43 
line referral) thereby enhancing the ecological validity of the study, while also minimizing 
44 
between-subject variability in the extent of participants’ exposure to these practices by 
45 
implementing these treatment components ourselves (described in greater detail below).  
46 

Page 6 of 31 
 
Although one common alternative is to use a non-contingent incentives control group which 
1 
equates both groups in terms of overall earnings, a meta-analysis conducted by UVM researchers 
2 
showed that non-contingent incentives have no impact on abstinence levels above no-incentive 
3 
control conditions.44  
4 
 
5 
This subset of 60 Alaska Native women will be randomized separately from the main trial 
6 
currently underway at UVM.  The rationale for a separate arm targeting Alaska Native women, 
7 
as opposed to including them in the main trial, is that smoking prevalence is substantially higher 
8 
among this subpopulation (i.e., ~ 36% for AN women [Patten et al. 2018] versus ~ 13% among 
9 
U.S. pregnant women overall [Kurti et al., 2017]), they exhibit unique tobacco use characteristics 
10 
including use of a homemade smokeless tobacco (Iqmik, Hurt et al., 2009), and very few 
11 
smoking cessation interventions have been implemented specifically among Alaska Native 
12 
women (Patten et al., 2010; Patten et al., 2018).  
13 
 
14 
Procedures: 
15 
Participants Study participants will be 60 Alaska Native pregnant women > 18 years of age.  
16 
Participants will be recruited from online media outlets (i.e., Facebook) targeting Alaska Native 
17 
pregnant women. That is, participants will self-refer after seeing our ads and will complete a 
18 
screening online or over the telephone with research staff. 
19 
  
20 
For inclusion in the study, women must meet the following criteria: (a) > 18 years of age, (b) 
21 
report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 
22 
7 days prior to completing their preliminary eligibility screening, (d) < 25 weeks pregnant, (e) 
23 
speak English, (f) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 
24 
[2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a 
25 
smartphone).  Exclusion criteria include: (a) current or prior mental or medical condition that 
26 
may interfere with study participation (assessed via self-report during formal intake assessment 
27 
completed online or by phone using a medical and psychosocial history questionnaire), (b) 
28 
smoke marijuana more than once each week and not willing to quit (marijuana smoking can 
29 
inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), 
30 
(d) report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine).  
31 
Women who meet the inclusion criteria and complete the informed consent process will be 
32 
considered formally enrolled and will be mailed equipment to participate in the study, but will 
33 
not be randomized until they (1) confirm receipt of their equipment, (2) complete an orientation 
34 
session on the smartphone app used in the current study (described subsequently), and (3) 
35 
provide a saliva sample indicating current smoking (i.e., test strip returns a positive for cotinine, 
36 
a metabolite of nicotine).  Upon completing these steps, women will be randomized to either the 
37 
best practices plus incentives condition or best practices control condition (See Treatment 
38 
Conditions).  The only criteria for withdrawing participants after randomization occurs will be 
39 
pregnancy termination or fetal demise. 
40 
 
41 
General Study Procedures. 
42 
 Orientation Session:  After verifying eligibility and completing the informed consent process, 
43 
participants will be mailed two saliva test kits.  Upon receiving the saliva tests, research staff will 
44 
aid participants in setting up their profile (e.g., create an account, upload profile photo) on the 
45 
DynamiCare smartphone application (“app”) which is used to submit breath and saliva samples 
46 

Page 7 of 31 
 
remotely. Participants will be trained in the operation of the app and will have the opportunity to 
1 
practice submitting saliva samples.  The first sample that participants submit upon receiving their 
2 
saliva test kits will be used to validate smoking status and participants will be withdrawn prior to 
3 
randomization if they are found to be non-smokers.  Women who provide a baseline saliva test 
4 
validating that they are smokers will be randomized to one of the two treatment conditions, and 
5 
will be provided with information about that condition and a brief quiz (see attached) as part of 
6 
their orientation session.  The orientation session will be conducted by telephone.  Prior to the 
7 
orientation session, participants will be mailed a CO monitor, additional saliva cotinine test kits, 
8 
and an instruction manual containing general information about study procedures and where to 
9 
download the app that they will use during their participation, as well as specific information 
10 
about how frequently they should submit breath and saliva samples and a schedule of potential 
11 
earnings.  Given that over 80% of pregnant women can be expected to own smartphones, these 
12 
women will use their existing phone during their participation to increase the ecological validity 
13 
of using a mobile phone to deliver the intervention.  Women who do not own a smartphone but 
14 
have access to a computer with Internet access may pursue this option instead.  We will collect 
15 
data on the number of participants who use mobile phones vs. computers to participate in the 
16 
intervention.  During the orientation session, participants will also be informed that we will cover 
17 
the costs of study-related data transfer if they do not have unlimited data plans with their wireless 
18 
service provider.  The purpose of this is to enhance the internal validity of this efficacy study by 
19 
reducing between subject variability in data coverage.  We will also collect data on the number 
20 
of participants who require assistance paying for data coverage.  Other details covered during 
21 
orientation include instructions specific to the condition to which participants are randomized 
22 
(e.g., schedule for submitting breath and saliva samples, the schedule of potential earnings, and 
23 
when the earnings commence).  Researchers will read participants an information sheet specific 
24 
to their treatment assignment (attached), which will be followed by a brief quiz (attached).  The 
25 
purpose of the quiz is simply to verify participant understanding of the condition to which they 
26 
are randomized.  Participants will respond aloud to the quiz questions over the phone and any 
27 
incorrect answers will be discussed, and they will be invited to ask any additional questions upon 
28 
completing the quiz.  Participants will select a quit date during orientation (either the first 
29 
Monday following the call or the next Monday), and research staff will contact them by phone 
30 
on the Friday prior to their quit date.  Staff will also inform participants to contact them in the 
31 
event that their phone is lost, stolen, or broken.  In sum, participants who complete the informed 
32 
consent process will be mailed two saliva test kits to verify their smoking status prior to being 
33 
assigned to one of the two treatment conditions.  Two tests will be sent in case participants’ first 
34 
sample is invalid (e.g., insufficient saliva to produce a reading) and they need to complete a 
35 
second test to verify smoking status.  Participants who are verified to be smokers will then 
36 
complete the treatment assignment phone call, after which study staff will provide them with the 
37 
equipment that they will need for the remainder of the study (e.g., breath CO monitor and 
38 
additional saliva test kits).  
39 
 
 
40 
Mobile-Phone Based Financial Incentives:  The intervention will be delivered on participants’ 
41 
smartphones via an app installed on their phone either before or during the orientation session.  
42 
The process of submitting a video entails the following steps: (1) Participant opens the app, 
43 
which requires them to type in a password.  Their username and password (stored as a secure, 
44 
“irreversible” one-way hash) will be stored in a configuration file accessible only to the 
45 
application; (2) The app will verify the password and participants will be taken to the “home” 
46 

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screen which will show their cumulative earnings to date and a “post video” button; (3) The app 
1 
will attempt to contact the server over the Internet (via a 3G/4G mobile network) to determine 
2 
the correct time and status of the participant; (4) The participant will click on the post video 
3 
button, thereby leading them to a simple interface for recording videos that contains a start/stop 
4 
recording toggle button, a play button to review the recorded video, and a post button to send the 
5 
video to the server; (5) After posting the video, the server will display a voucher based on the 
6 
voucher schedule cached from the prior video upload.  The app will then create a text file 
7 
containing a timestamp and video file.  These files will be archived, compressed, and encrypted 
8 
to prevent tampering and/or eavesdropping while in transit.  The app will maintain a file lock on 
9 
the video until it is discarded or posted to prevent participants from tampering with their videos; 
10 
(6) If a 3G/4G or WiFi Internet connection is available, the app will poll connection status in the 
11 
background until an upload can be initiated; (7) When the server receives the upload, the video 
12 
will be extracted and the content registered with the system; (8) A text message verifying that the 
13 
video was received will be sent to the participant and their account will be updated; (9) Research 
14 
staff will review and validate videos (see Validating Videos below).  Participants will be able to 
15 
check their recent and cumulative earnings on a mobile-friendly site.  These same steps will be 
16 
employed among participants using the computer-based treatment delivery platform.  The app 
17 
for use in the current study (DynamiCare Rewards) was designed by DynamiCare Health, Inc., 
18 
and DynamiCare Health, Inc. has partnered with numerous universities (UVM, Johns Hopkins 
19 
Univ., Medical University of South Carolina) and insurance companies (e.g., Aetna) for similar 
20 
purposes as the proposed study.  
21 
           
22 
Abstinence Criterion:  Consistent with the parent trial underway at UVM, participants will 
23 
receive incentives during week 1 for all breath CO samples where CO < 6 ppm.  Breath CO has a 
24 
relatively short half-life, thus twice daily CO testing during week 1 will help detect recent 
25 
smoking.  This frequency of testing also offers the advantage of allowing women to obtain 
26 
frequent access to reinforcement thereby engaging them early in the intervention.  Although 
27 
recent studies to promote smoking cessation among pregnant women have employed cut points 
28 
as high as 10 ppm87, existing data and our group’s experience suggest that moderate levels of 
29 
smoking can go undetected when using higher cut points.  After week 1, incentives will be based 
30 
on salivary cotinine levels.  Salivary cotinine has a longer half-life and thus is more appropriate 
31 
for the less frequent schedule of routine smoking monitoring that will ensue following week 1.  
32 
The test itself simply displays a positive or negative, however the equipment specifications 
33 
indicate that salivary cotinine > 30 ng/mL will register as positive which is consistent with the 
34 
cut point used in prior research conducted by UVM researchers.45 
35 
 
 
36 
Participants will be informed during their orientation session about environmental sources that 
37 
could elevate breath CO, as well as other sources of nicotine that could elevate salivary cotinine.  
38 
Specifically, research staff will inform participants that they should avoid second-hand or 
39 
environmental smoke, as well as smoking other combustible tobacco products and/or using 
40 
marijuana.  Thus CO readings above 6 ppm will always be considered positive during week 1 of 
41 
treatment (described subsequently).  Similarly, participants will be informed that other sources of 
42 
nicotine (e.g., e-cigarettes, nicotine replacement therapy) may result in positive saliva cotinine 
43 
tests which may prevent them from earning incentives from week 2 onwards. 
44 
           
45 

Page 9 of 31 
 
Smoking Monitoring:  We will use the iCO™ Smokerlyzer® (coVita, Inc.), a handheld 
1 
Smartphone-compatible CO monitor that connects to the phone via headphone jack or 
2 
Bluetooth® technology, to monitor smoking status during week 1.  Although the iCO™ 
3 
Smokerlyzer® readings can be viewed using the iCO Smokerlyer® app that is freely available at 
4 
both the Apple iOS App Store and Google Play Android App Store, DynamiCare Health, Inc. 
5 
has interfaced the monitor with their customized app to permit researchers to validate that breath 
6 
CO samples are submitted by the intended participants who are enrolled in the study.  The iCO™ 
7 
Smokerlyzer® permits a concentration range of 0-100 ppm and sensitivity results in individual 1 
8 
ppm increments.  The operating life is approximately 200 tests or 3 years (whichever comes 
9 
first), which will be adequate for the proposed study.  Following week 1, we will use Alere 
10 
iScreen OFD Oral Cotinine Screening tests to monitor smoking status via saliva cotinine testing.  
11 
Salivary cotinine has a longer half-life than breath CO, making it a more appropriate measure 
12 
with less frequent testing.  Subjects will submit videos of themselves completing the tests, with 
13 
each test taking approximately 5 minutes (i.e., 2-3 minutes of swabbing the mouth and tongue, 
14 
and up to 3 minutes to produce a result).  The display indicates whether the sample is either 
15 
positive or negative, with a positive test registering for salivary cotinine levels > 30 ng/mL. 
16 
  
17 
Treatment Conditions.   
18 
Best Practices: The 2008 Clinical Practice Guidelines for smoking cessation recommends that 
19 
pregnant smokers be provided with the 5As.88  Briefly, these guidelines stipulate that 
20 
practitioners should implement the following steps at obstetric visits: (1) Ask about smoking 
21 
status at the first prenatal care visit; (2) Advise those who endorse smoking about the potential 
22 
harms of smoking to mother and fetus and recommend quitting; (3) Assess the willingness of 
23 
smokers to make a quit attempt during pregnancy; (4) Assist those willing to make a quit attempt 
24 
by helping to establish a quit plan, referring them to a pregnancy-specific quit line and offering 
25 
assistance with making the initial contact, and by providing them with a copy of the pregnancy-
26 
tailored self-help guide “Need Help Putting Out That Cigarette?”, distributed by the American 
27 
College of Obstetricians and Gynecologists; (5) Arrange for follow-up contacts on smoking at 
28 
subsequent prenatal care visits.  As there may be differences in the extent to which the 5As are 
29 
implemented across obstetric clinics, research staff will implement the 5As at three assessments 
30 
that take place during pregnancy (see Assessment Procedures below) to decrease between-
31 
subject variability in exposure to best practice guidelines.  At the first antepartum assessment, 
32 
staff will complete a fax referral form for participants to the Alaska tobacco quit line, which 
33 
provides telephone-counseling calls with a trained smoking-cessation coach during pregnancy 
34 
and postpartum. In addition to completing the 5As and referring women to the quit line, all 
35 
women in the best practices condition will also receive the smoking cessation advice that is 
36 
provided at their obstetric clinic.  Note that pregnant women seeking smoking cessation 
37 
treatment in the community often do not receive cessation-focused follow-up visits after 
38 
endorsing that they are current cigarette smokers, nor do providers or community health workers 
39 
typically submit referrals for them to a quit line.  As we take these extra steps, we refer to this 
40 
condition as “best practices” rather than “usual care.”   
41 
 
42 
Best Practices plus Financial Incentives: Women assigned to this condition will receive the 
43 
best practices treatment described above plus the remote incentives intervention.  As mentioned 
44 
previously, participants will set a quit date during their orientation session for either the first or 
45 
second Monday following the session.  They may practice submitting samples (for which staff 
46 

Page 10 of 31 
 
will provide feedback) prior to their quit date if desired, however this is not required as they 
1 
would have already provided an initial sample to validate their smoking status prior to being 
2 
randomized.  Once the quit date arrives, participants will submit two breath CO samples each 
3 
day, separated by 8 hours from one another.  A day will start at 5:00 a.m. and end at 4:00 a.m. 
4 
(Alaska time).  The app will indicate to participants when samples can be collected because the 
5 
“post video” button will be locked for 8 hours after the first sample of the day is submitted. 
6 
 
7 
Beginning on the quit date and extending for one week, participants will be required to submit 
8 
twice daily CO samples.  All samples < 6 ppm will be considered negative and those > 6 ppm 
9 
will be considered positive.  Requiring frequent testing during week 1 only will permit 
10 
participants the opportunity to earn frequent reinforcement while their salivary cotinine levels 
11 
decrease more gradually if participants are not smoking over the course of week 1 of treatment.  
12 
As with our prior and ongoing trials, including the parent trial, the value of the incentive will 
13 
increase with consecutive negative samples indicating smoking abstinence.  If a sample has not 
14 
been submitted within the specified 8-hour time window, an electronic prompt will be sent to 
15 
submit a video two hours before the time window expires.  Missed samples will be considered 
16 
positive unless extenuating circumstances are reported (e.g., lost, stolen, broken phone).  The 
17 
schedule of potential earnings will be consistent with our prior trials adjusting for inflation.  Thus 
18 
rather than a maximum potential earnings of $1,200 (2002 USD), participants in the proposed 
19 
study may earn up to $1,620 (2017 equivalent of $1,200 in 2002) for sustaining smoking 
20 
abstinence during pregnancy and for 12-weeks postpartum.  The schedule of potential earnings 
21 
will start at $6.25 for the first negative sample and increase by $1.00 for each consecutive 
22 
negative sample.  Thus the second negative sample will be worth $7.25, the third worth $8.25, 
23 
and so on, until incentive values plateau at a maximum of $33.25.  If a participant submits a 
24 
breath CO > 6 ppm during week 1 or a positive saliva cotinine test any time after week 1, the 
25 
value of the incentive will be reset to the initial value of $6.25.  This reset component is critical 
26 
to protect against relapse once an initial period of abstinence has been achieved.89  
27 
 
28 
Following the initial quit week during which participants submit twice daily breath CO samples, 
29 
the schedule of monitoring will be reduced and saliva cotinine will be used to determine smoking 
30 
status.  Only tests where the display indicates negative samples will result in participants earning 
31 
reinforcement.  Specifically, during weeks two through six, participants will submit videos of 
32 
themselves completing saliva cotinine tests twice per week, then once per week from week seven 
33 
until delivery.  During the once per week phase, the specific day on which participants are 
34 
required to submit a sample will be determined quasi-randomly (at least two days apart).  The 
35 
sample will be prompted electronically via a text message at the start of the day and the 
36 
participant will have up to eight hours to provide the sample.  This provides a balance between a 
37 
schedule that is sufficiently unpredictable that participants who are no longer abstinent may be 
38 
detected, while at the same time providing them with a reasonable time frame to submit a sample 
39 
upon being prompted to do so.  The schedule of potential earnings during weeks two until 
40 
delivery will be a continuation of the escalating pay schedule from the initial quit week.  
41 
Importantly, intermittent reinforcement schedules induce more persistence than frequent, 
42 
predictable schedules,90,91 thus the schedule we are proposing may be optimal for promoting 
43 
persistence and sustained abstinence. 
44 
 
45 

Page 11 of 31 
 
As women who quit smoking during pregnancy are particularly vulnerable to relapse during the 
1 
early postpartum, the frequency of monitoring will increase to twice per week for the initial four 
2 
weeks postpartum.  After the first month, monitoring will be returned to the weekly, quasi-
3 
random prompted monitoring schedule for the next 8 weeks.  The opportunity to earn incentives 
4 
will be terminated at the end of postpartum week 12, consistent with our prior and ongoing 
5 
trials45,48 thereby permitting us to compare the results of the proposed intervention to our group’s 
6 
traditional, in person financial incentives interventions. 
7 
  
8 
Validating Videos.  Key personnel will validate participant videos daily during the workweek.  
9 
After logging in, the process takes less than ten minutes per video.  To be considered valid, the 
10 
videos of breath tests during week 1 must meet the following criteria: (a) have an authentic user 
11 
(i.e., a known, enrolled participant), (b) participant can be seen holding her breath for the 
12 
required duration, (d) participant can be seen and heard exhaling into the mouthpiece, and (e) 
13 
participant displays CO reading at the end of the video until the monitor indicates that the 
14 
reading is complete.  In one recent controlled trial that required remote submission of breath CO 
15 
samples, only 39 of 4,774 (0.8%) total samples submitted were problematic.55 Regarding videos 
16 
of saliva cotinine testing from week 2 through 12 weeks postpartum, videos must meet the 
17 
following criteria: (a) have an authentic user (i.e., a known, enrolled participant), (b) saliva 
18 
cotinine test kit is in view for entire duration of the video, (c) participant permits ample time to 
19 
collect the sample and collect a reading, and (d) test result is displayed clearly at the end of 
20 
video. 
21 
  
22 
Delivering Incentives.  Participants’ account activity box on their homepage will display their 
23 
recent and cumulative earnings.  In our group’s previous studies that used similar schedules of 
24 
potential earnings to what we are proposing here, participants earned (on average) $550 during 
25 
the intervention.15  Participants in the proposed study will receive a PEX Debit Card at the 
26 
beginning of the intervention onto which incentive payments will be loaded contingent on their 
27 
submission of breath and saliva samples indicating smoking abstinence.  These debit cards do 
28 
not require a credit history check, and participants will pay no monthly fees for carrying the card.  
29 
Moreover there are no costs for using the PEX Debit Cards for in-store or online shopping. 
30 
Research staff will load money onto participants’ study debit card after reviewing each video and 
31 
determining that the video meets the criteria for validation above.  Comparable methods of 
32 
incentive delivery have been employed in computer-based financial incentives treatments 
33 
targeting the general population of smokers,52-54 and no participants in Dr. Kurti’s parent study 
34 
have experienced problems or reported complaints associated to using PEX cards.  Importantly, 
35 
in-person financial incentives treatments typically require research staff to venture into the 
36 
community to make a incentive purchases (e.g., gift cards) in person and then deliver it to the 
37 
participant.  In contrast, the technology-based method that we are proposing is easy to implement 
38 
and will decrease both staff travel time to redeem incentives, as well as the immediacy between 
39 
engaging in the target behavior and receiving reinforcement. 
40 
 
41 
Assessment Procedures.  Participants in both the best practices plus incentives condition and the 
42 
best practices control condition will complete a formal assessment at intake, during early 
43 
pregnancy (i.e., one month after enrolling), late pregnancy (i.e., 28-weeks gestation), and at 4-, 
44 
8-, 12-, and 24-weeks postpartum.  This schedule of formal assessments and the use of similar 
45 
questionnaires (see Assessment Battery) will permit comparisons to prior controlled trials 
46 

Page 12 of 31 
 
conducted by UVM researchers.15,45-48  Participants will receive $50 per formal assessment 
1 
completed regardless of their smoking status.  This money may come in the form of a check 
2 
mailed to their home or in the form of a gift card (TangoCard) that is emailed to them.  
3 
TangoCard is an electronic gift card platform. If participants receive their rewards via this 
4 
option, the reward will be emailed to them as a unique URL. By following the URL, the 
5 
participant can choose from a variety of gift card brands and redeem their reward. Once they 
6 
select a brand, the final gift card will be emailed to them. To ensure that HIPAA security 
7 
standards are met and emails are kept private, TangoCard has signed a BAA (Business Associate 
8 
Agreement) with DynamiCare.  Questionnaires will be completed remotely via computer or 
9 
mobile phone.  Items will be administered using REDCap or SurveyGizmo, both of which 
10 
capture and house unique de-identified codes for study participants.  Data audits will be 
11 
conducted monthly during the first six months of the study and then quarterly until study 
12 
completion to detect problems.  As no personal identifying information will be collected, the 
13 
chance of a breach of confidentiality is very low.  Regardless of whether participants complete 
14 
the assessment online or over the phone, participants in both treatment conditions will be 
15 
required to submit both a breath CO sample and a salivary cotinine sample at each formal 
16 
assessment to determine their smoking status. 
17 
 
18 
Assessment Battery Participant’s intake assessment will be conducted after they have completed 
19 
a preliminary eligibility screening and appear to be eligible, and will address seven areas: (a) 
20 
Sociodemographics (age, educational attainment, marital status, health insurance status); (b) 
21 
Medical/pregnancy history (height/weight, self-reported pre-pregnancy weight, weeks pregnant, 
22 
history of complications in prior pregnancies; (c) Smoking history (age started smoking, pre-
23 
pregnancy time to first cigarette/cigarettes per day, past week time to first cigarette/cigarettes per 
24 
day, number of quit attempts before/during the current pregnancy, number of other smokers in 
25 
the household, rules about smoking in the household, nicotine dependence92); (d) Smoking 
26 
timeline follow-back (to characterize daily smoking rates and/or use of alternative tobacco 
27 
products or nicotine replacement therapy since learning of the current pregnancy93); (e) Smoking 
28 
attitudes (motivation to stop, confidence in ability to stop, intention to quit before the baby is 
29 
born, intention to remain abstinent after the baby is born, perceived stress levels); (f) Maternal 
30 
health/executive functioning (lifetime history of depression, general psychiatric symptoms,94 
31 
current depressive symptoms,95 discounting of delayed hypothetical monetary rewards,96 
32 
behavioral economic measure of the reinforcing value of cigarettes,68,97 Behavior Rating 
33 
Inventory of Executive Function®-Adult Form [BRIEF-A; see attached], EQ-5D Health-Related 
34 
Quality of Life Questionnaire [see attached]); (g) Stressful life events (SAMHSA Life Events 
35 
Checklist [see attached]).  Appropriately modified versions of these measures will be 
36 
administered at the other six formal assessments identified above.  In addition, at the postpartum 
37 
assessments we will assess breastfeeding, including initiation, duration, and different levels of 
38 
breastfeeding (e.g., exclusive, predominant, any).   
39 
              
40 
After participants’ consent to join the study, we will collect contact information over the phone 
41 
including their mailing address (to send them equipment), as well as the phone number for an 
42 
alternative contact in the case that we are unable to reach the participant.  We will also ask the 
43 
participant to tell us how we should describe their involvement in the research study should we 
44 
need to reach out to their alternative contact at some point.  This form is attached, and it will be 
45 

Page 13 of 31 
 
updated following each formal assessment.  Keeping an updated mailing address is important in 
1 
case participants need additional equipment or paperwork mailed to them. 
2 
 
3 
Regarding the cost-effectiveness analysis, we will employ the Brief Drug Abuse Treatment Cost 
4 
Analysis Program (Brief DATCAP;98,99) to estimate the cost of delivering the Incentives versus 
5 
Best Practices smoking cessation treatments.  More specifically, we will derive the direct and 
6 
indirect economic cost of treatment by allocating fixed costs based upon the proportion of time 
7 
spent delivering these programs, as well as costs that vary by patient engagement and smoking 
8 
status (e.g., staff time validating breath CO samples, quit-line staff time, incentives).  
9 
Administration costs (e.g., postage/courier service to mail participants CO monitors) will also be 
10 
included.  Costs will be in USD for price year 2021/2022.  The time period of the cost analysis 
11 
will span from intake to discontinuation or completion of the program.  However, since the 
12 
duration of treatment will vary according to where in the pregnancy a woman enters the study, 
13 
the economic cost per person per week will also be calculated.  Research-specific resources 
14 
consumed over the course of the study will be excluded from the cost-effectiveness analysis. 
15 
           
16 
Examining Acceptability.  At the 24-week postpartum assessment or shortly thereafter, 
17 
participants in both the best practices plus incentives condition and best practices control 
18 
condition will complete a Treatment Acceptability Questionnaire (TAQ) comparable to those 
19 
administered in other financial incentives interventions,21 including research conducted by Dr. 
20 
Kurti.61,64  The measure will be administered on REDCap and will query participants about the 
21 
ease of use, helpfulness, and convenience of the intervention, as well as whether the intervention 
22 
was fair, fun, and whether they would recommend it.  All responses will be made using a 100-
23 
point visual analogue scale.  Participants in the best practices plus incentives condition will 
24 
receive additional TAQ questions inquiring about whether they liked self-monitoring their breath 
25 
CO levels, liked the incentives, and whether the incentives were helpful in terms of promoting 
26 
smoking abstinence during treatment and sustaining abstinence following treatment withdrawal.  
27 
In addition, research staff will call all participants upon completing the 24-week 
28 
assessment/TAQ to query them about barriers and facilitators of treatment engagement 
29 
including: (a) features of the intervention that they felt facilitated or hindered engagement (e.g., 
30 
technical difficulties/availability of technical support, self-monitoring using the CO monitor, 
31 
appropriateness of staff counseling surrounding smoking), (b) social/environmental variables 
32 
(e.g., quit support from friends/family, rules about smoking in the home, exposure to smoke-free 
33 
environments, social networks that promoted or discouraged quitting smoking) and (c) 
34 
internal/psychological variables (e.g., stress, psychological well-being, motivation to quit, self-
35 
efficacy for quitting smoking).  The semi-structured interview used to examine barriers and 
36 
facilitators of treatment engagement will use scripted prompts, however participants will be able 
37 
to respond freely and openly to each question.  Their responses may be transcribed verbatim by 
38 
the research staff completing the interviews, or participants may type them into open-ended text 
39 
boxes. 
40 
 
41 
STATISTICAL CONSIDERATIONS 
42 
 
43 
Statistical Methods 
44 
Study conditions will be compared on baseline demographics and other characteristics using 
45 
analysis of variance (ANOVA) for continuous variables and chi-square tests for categorical 
46 

Page 14 of 31 
 
variables.  If a specific characteristic differs significantly across study conditions and is 
1 
predictive of the outcome, it will be considered as a potential covariate in subsequent analyses.  
2 
Analyses of treatment effects on smoking status will adhere to an intent-to-treat approach100 
3 
whereby all women randomized to each study condition will be included in the analyses 
4 
independent of early dropout, noncompliance, etc., with the exception of women excluded for 
5 
abortion/fetal demise as is convention in this research area.  Cochran-Mantel-Haenszel tests (C-
6 
M-H) will be performed for comparisons between the best practices plus incentives vs. best 
7 
practices alone conditions on point-prevalence smoking abstinence at the end-of-pregnancy and 
8 
6-months postpartum assessments.  Comparisons of point-prevalence abstinence rates between 
9 
treatment conditions across all assessments through six months postpartum will be analyzed 
10 
using mixed model repeated measures for categorical data based on generalized estimating 
11 
equations (GEE) using a logistic link function (SAS: PROC GENMOD, SAS Institute, Cary, 
12 
NC).  The two treatment groups will also be compared on breastfeeding and other measures 
13 
collected postpartum.  Comparisons of treatment conditions on dichotomous outcomes (e.g., % 
14 
breastfeeding) will parallel categorical analyses for point prevalence abstinence using PROC 
15 
GENMOD to adjust potential covariate effects.  The significance criterion will be set at alpha = 
16 
0.05 for all analyses. 
17 
 
18 
Regarding the cost-effectiveness analysis (CEA), the CEA will be conducted by dividing the 
19 
average (mean) difference in treatment costs across the best practices plus incentives versus best 
20 
practices conditions by the average (mean) difference in abstinence rates in late pregnancy to 
21 
derive incremental cost-effectiveness ratios (ICERs).101  Statistical significance of these ICERs 
22 
will be determined probabilistically by employing non-parametric bootstrapped standard 
23 
errors.102  The main objective of this preliminary CEA will be to establish methods for obtaining 
24 
and analyzing data that pertain to treatment delivery in remote financial incentives interventions. 
25 
This basic CEA data will provide important preliminary data for a future RO1 application in 
26 
which we may propose conducting a more sophisticated cost-effectiveness analysis.  
27 
 
 
28 
Regarding the acceptability data, TAQ items administered using a 100-point VAS will be 
29 
compared across the two treatment conditions using ANOVA’s.  Again characteristics that differ 
30 
across treatment condition will be considered as potential covariates.  Responses to the semi-
31 
structured interview questions will be analyzed afterwards using a thematic content 
32 
analysis.103,104  We will employ an inductive approach whereby the content of these qualitative 
33 
data will direct the coding and theme development.  Coding of the data will involve grouping, 
34 
sorting, and identifying themes that reflect barriers and facilitators of treatment engagement.  
35 
Two researchers will perform the content analysis independently and sort responses into themes.  
36 
Disagreements will be resolved through discussion until consensus is reached.  Those themes 
37 
that emerge and reflect modifiable aspects of the intervention (e.g., provision of technical 
38 
support, appropriateness of staff counseling and feedback surrounding quitting smoking) will be 
39 
taken into account in designing future iterations of this intervention that are more responsive to 
40 
participant’s preferences. 
41 
 
42 
As our examination of the intervention among the proposed subgroup of Alaska Native women 
43 
represents the first feasibility and proof of concept assessment to our knowledge, power analyses 
44 
were not conducted to determine the sample size needed to obtain statistically significant effects 
45 
on the above outcomes.  However, once we complete our assessment of the feasibility and 
46 

Page 15 of 31 
 
efficacy of smartphone-based financial incentives among this subset of Alaska Native women, 
1 
such analyses will be conducted to determine the sample size needed in future, larger-scale 
2 
studies targeting this unique subpopulation.  
3 
 
4 
Sample Size Justification 
5 
A sample size of 60 Alaska Native women was selected based on initial pilot studies of the 
6 
financial-incentives-based approach to promoting smoking cessation among pregnant women 
7 
developed at the University of Vermont (Higgins et al., 2004), as well as Dr. Kurti’s pilot study 
8 
of 60 women receiving best practices plus smartphone-based financial incentives or best 
9 
practices alone, which was sufficient to detect treatment differences during pregnancy and 
10 
postpartum.  This sample size will be sufficient to determine whether the intervention is feasible 
11 
and effective at promoting late-pregnancy smoking abstinence between Alaska Native women 
12 
enrolled in the best practices plus incentives versus best practices Control conditions. Results of 
13 
our assessment will be used to inform power analysis calculations for larger-scale, NIH-
14 
supported research proposals focused on smoking cessation among Alaska Native pregnant 
15 
women.  
16 
 
17 
 
18 
RISKS/BENEFITS 
19 
 
20 
Risks 
21 
Participants may experience some discomfort arising from nicotine withdrawal.  Participants will 
22 
be informed during the informed consent process that they may experience the following 
23 
symptoms of nicotine withdrawal: craving cigarettes, restlessness, irritability, increased appetite, 
24 
increased eating, dizziness, difficulty concentrating, and depressed mood.  There is a small risk 
25 
that participants’ electronic information could be accessed thereby affecting confidentiality.  
26 
There is a risk that women may be uncomfortable answering some of the questions on the formal 
27 
assessment batteries.  There is a risk that use of other combustible tobacco products and/or 
28 
marijuana during study participation may elevate participants’ breath CO levels thereby 
29 
preventing them from earning incentives during week 1 even if they have quit smoking 
30 
cigarettes.  Similarly, use of other nicotine products like e-cigarettes or nicotine replacement 
31 
therapy could elevate salivary cotinine levels after week 1 and prevent subjects from earning 
32 
incentives. There is also a risk that a participant may become distraught during the course of the 
33 
study and become a danger to herself, or that other emergencies could arise that research staff 
34 
may need to address. 
35 
 
36 
Summary of Protection Against Potential Risks 
37 
We will take the following actions to protect against potential risks: (a) We will inform women 
38 
during the informed consent process that reducing and/or quitting smoking may result in nicotine 
39 
withdrawal symptoms however these symptoms should disappear within two weeks.  (b) To 
40 
ensure participant confidentiality, all study files will be stored in locked filing cabinets.  All 
41 
participants receive a subject identification code that is used in place of their name in all study 
42 
files.  The key connecting names and ID codes is kept in a locked file and stored separately from 
43 
the data files.  Study computers are password protected and encrypted.  These protections apply 
44 
only to study data collected via paper/pencil methods (e.g., phone eligibility screening data 
45 
recorded by research staff).  (c) For subjects who self-refer and complete their preliminary 
46 

Page 16 of 31 
 
eligibility screening online, the survey will be administered using UVM’s REDCap system.  
1 
REDCap (Research Electronic Data Capture) is a secure, web-based application designed to 
2 
support data capture for research studies that is hosted at UVM. REDCap has various security 
3 
features, such as requiring usernames & passwords to access REDCap, and then needing 
4 
permissions for the individual project.  REDCap is accessed by URLs starting with HTTPS 
5 
which encrypts data before being sent over the internet.  (d) With respect to the assessment 
6 
batteries conducted using REDCap or SurveyGizmo, we will not ask participants to self-report 
7 
identifying information and both the REDCap and SurveyGizmo platforms are configured such 
8 
that they do not retain identifying information (including IP addresses), thus a breach of 
9 
confidentiality is exceedingly unlikely.  (e) Participants will be informed during the informed 
10 
consent process and again before completing the assessment batteries that they may skip 
11 
questions or stop at any time should they feel uncomfortable answering some of the items.  (f) 
12 
Regarding the use of other tobacco products, we will inform women that the use of other 
13 
combustible products could influence their breath CO and thereby limit their ability to earn 
14 
incentives during week 1, and that using other nicotine-containing products following week 1 
15 
could influence saliva cotinine levels thereby preventing them from earning incentives from 
16 
week 2 onwards.  (g) If the investigative team or research staff are concerned that a given 
17 
participant may be experiencing thoughts of harming themselves or others, this information will 
18 
be immediately acted upon by staff and investigators (e.g., crisis services in the participant’s 
19 
community will be contacted).  Research staff will be trained to deal with emergency calls.  
20 
Protocols for assessing and responding to suicidality include a suicidality assessment checklist 
21 
and a plan to call Crisis Services if any intent is demonstrated.  If Alaska Native women are 
22 
sufficiently remote that there are no local Crisis Services Centers available, study staff will 
23 
contact the regional hospital operator in Alaska and request to speak with the on-call physician.  
24 
The study staff in Anchorage and Rochester will monitor any reports or observations of medical 
25 
problems or severe depression or other psychiatric symptoms in participants.  Drs. Patten and 
26 
Prochaska, licensed clinical psychologists, will be consulted by telephone to consult with study 
27 
staff as needed. 
28 
 
29 
The study investigators will oversee all procedures designed to continuously monitor participant 
30 
safety.  The investigative team will meet once each week to discuss actual or potential issues for 
31 
each participant.  During these meetings, investigators will review all participants’ progress to 
32 
ensure treatment fidelity. 
33 
 
34 
Benefits 
35 
The benefits of the study are considerable.  All participants will receive the 5As from research 
36 
staff as well as the opportunity to have a staff member submit a fax referral form on their behalf 
37 
to the Alaska tobacco quit line.  Thus all participants will receive instructions about when to quit 
38 
and counseling surrounding their smoking, as well as feedback about their smoking status upon 
39 
providing breath CO and saliva samples.  If they are successful in abstaining from smoking, all 
40 
participants will receive positive feedback.  Importantly, as both conditions involve treatment, 
41 
the primary benefit of participating will be the potential for women to quit smoking, which may 
42 
have important immediate and long-term health benefits for both the mother and her offspring.  
43 
Women randomized to the contingent incentives condition have the opportunity to earn 
44 
incentives that can be used to purchase goods and services that may help improve their quality of 
45 
life (e.g., groceries, gas, baby clothes). 
46 

Page 17 of 31 
 
 
1 
There is a reasonable likelihood that women assigned to the best practices condition will not 
2 
achieve outcomes as good as those assigned to the best practices plus incentives condition.  
3 
Nevertheless, all women will receive treatment that meets Best Practices as outlined in the 2008 
4 
Clinical Practice Guidelines on Treating Tobacco (Fiore et al., 2008).  
5 
 
6 
Although the study is considered high-risk by definition (i.e., pregnant population), the potential 
7 
benefits are substantial in terms of our scientific understanding of the effectiveness of mobile-
8 
phone-based financial incentives interventions targeting pregnant smokers.  Overall, the 
9 
risk/benefit ratio appears highly favorable. 
10 
 
11 
Importance of the Knowledge to be Gained 
12 
Cigarette smoking is the largest preventable risk factor for morbidity and mortality in developed 
13 
countries and involves considerable risks to fetal and infant health.  Smoking during pregnancy 
14 
can lead to spontaneous abortion, preterm birth, stillbirth, low-birth weight, and sudden infant 
15 
death syndrome, as well as the development of later in life chronic conditions.  The proposed 
16 
study may suggest that mobile phone based incentives hold significant clinical utility and 
17 
promise.  If so, the platform for delivering the intervention remotely is sufficiently flexible that it 
18 
could be modified to treat other vulnerable populations such as those with mental illness or 
19 
adolescents in the future.  Because distance and traveling are not limiting factors in applying the 
20 
treatment, the system may also prove to be especially beneficial among rural populations.  In 
21 
short, the knowledge gained could help us develop an effective and broadly applicable treatment 
22 
to mitigate the morbidity and mortality associated with cigarette smoking during pregnancy.   
 
23 
 
24 
Moreover, regarding Alaska Native women specifically, the proposed study will be the first to 
25 
examine the efficacy of this approach among this population.  If the intervention proves to be 
26 
efficacious among Alaska Native women, it stands poised to make a significant contribution to 
27 
reducing the disproportionately high smoking rates during pregnancy among Alaska Native 
28 
women, and thereby reducing health disparities. 
29 
 
30 
Therapeutic Alternatives 
31 
Women can utilize the free State tobacco quit line and related services outside of the context of 
32 
this study.  They can also choose to rely on the services offered by their providers. 
33 
 
34 
 
35 
DATA SAFETY AND MONITORING 
36 
 
37 
Data Safety and Monitoring Plan 
38 
The proposed study will utilize the same plan as the parent trial underway at UVM.  This overall 
39 
monitoring plan consists of ongoing, close monitoring of data and safety issues by the PI and 
40 
other project staff and prompt reporting of any adverse events (AEs) or serious adverse events 
41 
(SAEs) to the institutional review board and/or NIGMS. 
42 
 
43 
Patient eligibility and status 
44 
All recruitment will be managed by trained research staff under the supervision of Dr. Diann 
45 
Gaalema (Project PI, UVM), Dr. Kaitlyn Browning (Project Postdoctoral Fellow, UVM), Dr. 
46 

Page 18 of 31 
 
Stephen Higgins (Center PI, UVM), and Dr. Kathy Koller (Site PI, ANTHC) using specialized 
1 
forms and procedures. All information collected will be reviewed by the research staff, PI, or 
2 
designated representatives, who will determine participant eligibility, contact them about 
3 
scheduling and completing an intake assessment where appropriate. Eligible women will 
4 
complete the informed consent process over the phone, after which they will be mailed a paper 
5 
copy of the full consent form along with their equipment to participate in the study. The consent 
6 
procedure is described in greater detail elsewhere and recent research published in JAMA 
7 
demonstrates the feasibility of completing the informed consent process over the phone 
8 
(McConnell et al., 2017).  The status of all active participants will be reviewed weekly at staff 
9 
meetings between the PI/Research Assistant and other trained support staff. 
10 
 
11 
 
12 
Confidentiality  
13 
Steps will be taken to ensure confidentiality of all written and electronic information.  With 
14 
regard to written information, all study files will be stored in locked filing cabinets at UVM.  All 
15 
participants receive a subject identification code that is used in place of their name in all study 
16 
files.  The key connecting names and ID codes is kept in a locked file and stored separately from 
17 
the data files.  Study computers are password protected and encrypted.  With respond to 
18 
electronic information, the server will be protected from outside intrusion by multiple firewalls.  
19 
Administrative access to the machines will only occur using SSH, a secure, encrypted protocol 
20 
for remotely connecting to a machine.  The servers will be hardened against attack using some of 
21 
the concepts deployed in the Bastille Linux project, a project whose purpose is to automate some 
22 
of the processes involved in hardening the Linux operating system.  Security will be periodically 
23 
monitored using network mapping tools, like nmap which probe machines for vulnerabilities and 
24 
report the results to the system administrator.  The software Port Scan Attack Detector (PSAD) 
25 
will be used to monitor the servers and notify administrators if they come under attack.  The 
26 
Advanced Intrusion Detection Environment (AIDE) will be used to detect if any unauthorized 
27 
changes are made to the machine, allowing us to identify and fix changes that might be made to 
28 
critical files in the unlikely event of a break-in.  Servers will be backed up nightly to external 
29 
hard drives using an encrypted file system.  External hard drives will be rotated offsite weekly 
30 
and stored in the PD’s office in a locked, data-safe firebox.  The software vendors/developers 
31 
websites will be monitored for security patches and upgrades.  Additionally, the server 
32 
appliance’s Linux operating system provides a means for monitoring and regularly installing 
33 
security patches.  See the Data Monitoring Plan for further information about protection against 
34 
risks. As staff training is crucial to ensuring confidentiality, all study personnel will receive 
35 
certification in human subjects’ protection from the Collaborative Institutional Training Initiative 
36 
(CITI) prior to beginning work on this project. 
37 
 
38 
Auditing procedures 
39 
Review of any problems related to quality of data collection, transmission or analyses, and of 
40 
any AEs and SAEs that occurred during the past week will occur at weekly research staff 
41 
meetings held by Drs. Gaalema, Browning, and Higgins at UVM. 
42 
 
43 
Adverse Event (AE) and Unanticipated Problem (UAP) Reporting 
44 
In the proposed study, we will use the FDA’s definition of AEs and SAEs. AEs and SAEs will be 
45 
assessed at each subject visit by a trained staff member, and will be discussed at the weekly 
46 

Page 19 of 31 
 
research staff meetings. Any SAE will be brought to the attention of the PI as soon as possible 
1 
and not longer than 24 hours. Any AE or SAE that is both unexpected and related to the study 
2 
participation will be reported to the IRB within 7 days of the event. That IRB will make a 
3 
determination as to whether additional reporting requirements are needed. IRB actions will be 
4 
reported to the funding agency by the PI no less than annually and more frequently as 
5 
recommended by the local IRB. Any SAEs will be summarized in the yearly Progress Reports to 
6 
the funding agency, including a review of frequency and severity. All SAEs will be followed 
7 
through ongoing consultation with the physician caring for the patient until they resolve, result in 
8 
death, or stabilize and are not expected to improve. 
9 
 
10 
Withdrawal Procedures 
11 
Women will be free to withdraw at any point during the course of the study without penalty.  
12 
That will be explained during informed consent.  In terms of data analysis, we will adhere to an 
13 
intent-to-treat approach (Armitage, 1983) wherein all women randomized to the study conditions 
14 
will be included in the analyses independent of early dropout, noncompliance, etc., with the 
15 
exception of excluding women for abortion/fetal demise prior to their late pregnancy smoking 
16 
assessment.  Women who receive their equipment and fail to complete an orientation session, as 
17 
well as women who provide a baseline CO sample indicating that they are non-smokers, will be 
18 
withdrawn prior to randomization and thus not included in an intent-to-treat analysis. 
19 
 
20 
Sources of Materials  
21 
The research materials to be obtained include interviews, questionnaires, and breath and saliva 
22 
specimens to verify smoking status (and serve as the basis for reinforcement in the incentives 
23 
condition).  Materials will be collected remotely using a combination of phone calls with 
24 
participants, online surveys, and remote video capture via smartphone app (i.e., for submission of 
25 
breath CO samples and salivary cotinine samples). These data will be entered into databases with 
26 
no identifying information (i.e., with subject ID only).  These databases are stored on password-
27 
protected external hard drives in locked offices in a locked clinic accessible only to the PI and 
28 
research staff. 
29 
 
30 
SUBJECT CHARACTERISTICS, IDENTIFICATION AND RECRUITMENT 
31 
 
32 
Subject Selection 
33 
We are studying Alaska Native pregnant women who are currently cigarette smokers to develop 
34 
more effective interventions to help this population quit smoking.  As noted previously, the 
35 
frequent biochemical verification required by in-person financial incentives interventions often 
36 
limits the number of individuals we can treat, as some women live in remote areas and/or lack 
37 
reliable transportation to a clinic.  Targeting pregnant smokers in a remotely delivered 
38 
intervention may provide an innovative means of transcending these historical barriers to 
39 
treatment.  Additionally, smoking prevalence is substantially higher among Alaska Native 
40 
pregnant women (i.e., ~ 36% [Patten et al. 2018] versus ~ 13% among U.S. pregnant women 
41 
overall [Kurti et al., 2017]), they exhibit unique tobacco use characteristics including use of a 
42 
homemade smokeless tobacco (Iqmik, Hurt et al., 2009), and very few smoking cessation 
43 
interventions have been implemented specifically among Alaska Native women (Patten et al., 
44 
2010; Patten et al., 2018).  Thus, the proposed pilot study represents the first examination of the 
45 
feasibility and effectiveness of financial incentives to reduce smoking targeting this specific 
46 

Page 20 of 31 
 
population and may provide important preliminary data for future grant applications to 
1 
disseminate the present intervention among Alaska Native women on a larger scale.  
2 
 
3 
Vulnerable Populations 
4 
Pregnant women to develop more effective interventions to help them quit smoking. 
5 
 
6 
Number of Subjects 
7 
60 Alaska Native women. 
8 
 
9 
Inclusion/Exclusion Criteria 
10 
A total of 60 Alaska Native pregnant women will be recruited.  The inclusion criteria include: (a) 
11 
> 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) 
12 
report smoking in the 7 days prior to completing their initial eligibility screening, (d) < 25 weeks 
13 
pregnant, (e) speak English, (f) own a smartphone (Android or iOS; 81.8% of pregnant women in 
14 
wave 1 [2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported 
15 
owning a smartphone).  The exclusion criteria include: (a) current or prior mental or medical 
16 
condition that may interfere with study participation (assessed via self-report), (b) smoke 
17 
marijuana more than once each week and not willing to quit (marijuana smoking can inflate 
18 
breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) 
19 
currently maintained on opioid maintenance therapy.  The only criteria for withdrawing someone 
20 
from the trial following randomization to treatment condition will be pregnancy termination or 
21 
fetal demise prior to participants’ late-pregnancy smoking assessment (> 28 weeks gestation).  
22 
Women who fail to complete an orientation session or provide an initial CO sample indicating 
23 
that they are smokers will be withdrawn prior to randomization.  Criteria will be assessed during 
24 
an initial eligibility screen that can be conducted either online or by phone to determine 
25 
preliminary eligibility and further evaluated during the formal intake assessment. 
26 
 
27 
Inclusion of Minorities and Women 
28 
This project will include only women. Smoking among pregnant and newly postpartum women 
29 
has sufficiently special circumstances regarding the potential toxicity to the fetus and newborn, 
30 
the reasons for trying to quit smoking and prevent relapse, and the patterns of smoking reduction, 
31 
cessation, and relapse that they need to be studied exclusively in women. 
32 
 
33 
Additionally, the project will include only Alaska Native women.  However, should we receive 
34 
referrals from non-Alaska Native women in Alaska who are pregnant and currently smoking, we 
35 
will refer them to the Alaska tobacco quit line. 
36 
 
37 
Recruitment 
38 
As in prior and current trials conducted at UVM, including the ongoing parent trial, applicants 
39 
will be recruited from online media advertisements. The text for these ads, as well as exemplars 
40 
of pictures, are attached to this submission.  These ads were developed based on prior research 
41 
conducted by the ANTHC involving online recruitment of Alaska Native women. These ads will 
42 
include a link to the preliminary screening questions administered through REDCap. If eligible, 
43 
we will collect the participant’s contact information and schedule a time to contact them to 
44 
provide more information about the study and conduct the consent phone call if they choose to 
45 
enroll. 
46 

Page 21 of 31 
 
 
1 
 
2 
 
3 
FINANCIAL CONSIDERATIONS 
4 
 
5 
Expense to Subject 
6 
No known expense to subject aside from their time. 
7 
 
8 
Payment for Participation 
9 
Women in both conditions will receive compensation for completing 7 formal assessments at 
10 
$50/assessment = $350. Women assigned to the best practices plus incentives condition will 
11 
have the potential to earn incentives in the form of money loaded onto a PEX Debit Card for 
12 
abstaining from smoking. The incentives that participants earn will vary depending on how early 
13 
in the pregnancy she enters the study and how well she abstains from smoking. However, the 
14 
maximum potential amount that a woman could earn is approximately $1620 in incentives.  This 
15 
total is equivalent to the maximum total earnings in prior UVM trials adjusted for inflation 
16 
($1,200 in 2002 USD = $1,600 today). 
17 
 
18 
Collaborating Sites 
19 
The present study represents a collaboration between University of Vermont (Project PI-Diann 
20 
Gaalema, PhD & Center PI-Stephen Higgins, PhD) and the Alaska Native Tribal Health 
21 
Consortium (ANTHC), Anchorage Alaska.  The Site Principal Investigator for the ANTHC is 
22 
Dr. Kathy Koller, Ph.D.   Dr. Koller’s research focuses on developing novel, theory-based 
23 
behavioral interventions for tobacco cessation, including NIH-supported intervention programs 
24 
to reduce tobacco disparities among Alaska Native adolescents and pregnant women.  The co-
25 
investigators at the ANTHC are Dr. Timothy Thomas, MD (ANTHC), Dr. Christi Patten, PhD 
26 
(Mayo Clinic, Rochester, MN), and Dr. Steven Steinbubl, MD (ANTHC). UVM IRB approvals, 
27 
as well as the Human Subjects Research Protocol currently on file at UVM, are attached to this 
28 
submission.  
29 
 
30 
 
31 
INFORMED CONSENT 
32 
 
33 
Consent Procedures 
34 
With respect to the informed consent process, eligible participants will be given detailed 
35 
information about the study including the following: (a) each study condition; (b) cash 
36 
compensation for their time (e.g., completing assessments); (c) the process of randomization and 
37 
the equal chance of being assigned to one of the two study conditions; (d) protection of 
38 
confidentiality and the right to withdraw at any time; (e) expectations regarding the completion 
39 
of formal assessments during and following their delivery (regardless of smoking status); (f) 
40 
risks and benefits of study participation; and (g) our procedures for dealing with any 
41 
endorsement of suicidality of self-harm. Contact information for the Project Postdoctoral 
42 
Fellow/Primary Project Contact (Dr. Browning), the Project Research Associate in Alaska at the 
43 
ANTHC (Lauren Gillott), the Project PI (Dr. Gaalema), Site PI (Dr. Koller), and the contact 
44 
person at the Alaska Area IRB will be provided during the verbal consent as well as included in 
45 
the paper copy of the Informed Consent Form that is mailed to subjects’ homes.  Participants will 
46 

Page 22 of 31 
 
be competent adults who can provide their voluntary informed consent.  The informed consent 
1 
process will be completed over the phone, and we will use the attached Consent & Authorization 
2 
Process Documentation form to document Mom’s consent to participate in a smoking cessation 
3 
study.  Researchers will read the attached Research Information Sheet to participants and they 
4 
will be provided the opportunity to ask questions or postpone providing their verbal consent to 
5 
another time if they need more time to decide whether to participate. 
6 
 
7 
After answering any questions, the participant may provide verbal consent to participate.  
8 
Researchers will mail a paper copy of the full consent form to participants along with equipment 
9 
to participate in the study.  A recent study in JAMA demonstrated the feasibility of completing 
10 
the informed consent process remotely using Smartphones (McConnell et al., 2017).  
11 
 
12 
UVM investigators will be responsible for eligibility screenings, and for moving women through 
13 
the informed consent process. 
14 
 
15 
 
 
16 

Page 23 of 31 
 
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