Small Financial Incentives to Promote Smoking Cessation

Individuals (N = 320) will be recruited during their initial visit to the Tobacco Cessation
Clinic. Eligible participants (N = 320) will be randomized to: 1) Standard Care, which is
counseling and pharmacological treatment (SC; n = 160), or 2) SC + adjunctive financial
incentives through 12 weeks post-quit (CM; n = 160). All participants will be followed weekly
from 1 week pre-quit through 4 weeks post-quit, and will return for visits at 8, 12, and 26
weeks post-quit. Biochemically verified 7-day point prevalence abstinence will be assessed at
all visits, though abstinence at 26 weeks post-quit (longer-term abstinence) will serve as
the primary outcome variable. Those randomized to the CM intervention will have the
opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks
post-quit. The value of the gift cards will escalate weekly with continuous abstinence from
the quit date through 4 weeks post-quit. Additional gift cards for abstinence may be earned
at 8 and 12 weeks post-quit. We also hope to gain a better understanding of CM treatment
mechanisms and to identify other factors that directly influence cessation via traditional
questionnaire and smartphone-based ecological momentary assessment approaches. Smartphone
technology allows for "real-time" data collection to more accurately capture important
cessation-related variables, and will be used to deliver gain-framed messages to support and
strengthen the CM intervention. Participants will complete traditional questionnaire measures
on a laptop computer weekly from 1 week pre-quit through 4 weeks post-quit, and at 8, 12, and
26 weeks post-quit. Assessments will be completed by participants either before or after
their counseling appointments, for which they will receive reimbursement in the form of gift
cards. Participants will also receive a smartphone at the 1 week pre-quit visit and they will
be asked to carry it with them at all times through 4 weeks post-quit in order to complete
EMAs (5 weeks total). Participants will be prompted to complete EMA assessments 5 times per
day (4 random assessments + 1 daily diary) for five consecutive weeks. Participants will be
compensated upon the return of the smartphone, based on the percentage of random/daily diary
assessments that they completed.

Description of Standard Care. According to the Clinical Practice Guideline, currently
recommended components of an intensive tobacco treatment intervention include 1) initial
assessment of willingness to participate, 2) the use of multiple types of clinicians (e.g.,
medical, non-medical), 3) at least 4 treatment sessions, in an individual- or
group-counseling format, that are greater than 10 minutes in duration, 4) counseling that
includes problem-solving, skills training, and social support components, and 5) and the
opportunity to use effective medications to aid in tobacco cessation (e.g., nicotine patch,
varenicline). The clinic currently offers all components of standard care. Specifically,
individuals who would like to quit smoking are referred (typically via electronic medical
record). Patients are scheduled for their initial appointment with a Tobacco Treatment
Specialist for an individual counseling session and to discuss pharmacological treatment
options. Nicotine replacement therapy is provided during the session, or other medications
are prescribed via communication with the patient's physician or by a provider on-site. Those
enrolled in the current study will be encouraged to attend at least 5 weekly group sessions
to facilitate follow-up and the delivery of study incentives.

Visit 1, Part 1 (Recruitment/Screening). Individuals attending the initial clinic intake
session will be provided with a 1-page informational handout with information about the
study. After the session, study staff will check in with potential participants regarding
their interest. Study staff will review the consent form with interested participants, and
they will be screened for eligibility on-site in a private room in the clinic. Participant
eligibility for the current study will not influence eligibility for standard treatment
through the clinic. The Rapid Estimate of Adult Literacy in Medicine (REALM; see Appendix A)
will be administered to ensure that all participants are able to read at ≥ sixth grade level
(i.e., required to complete EMA and self-report questionnaires). Expired carbon monoxide (CO)
will be measured with a Vitalograph BreathCO carbon monoxide monitor. Participants will be
questioned about their 1) insurance status 2) age, 3) current level of smoking, 4)
willingness to quit smoking, and 5) willingness/ability to attend 6 weekly sessions
(including the first visit). Eligible participants may complete the assessment portion of
visit 1.

Visit 1, Part 2 (Pre-Quit Assessment). Participants will complete self-report questionnaires
on a laptop computer; and expired CO, weight, and height will be measured in a private room
to ensure confidentiality. Participants will be provided with an Android smartphone and
instructed regarding the use of the phone (participants may make personal calls) as well as
the EMA procedures. Participants will receive 4 random prompts and 1 daily diary prompt (in
the morning) during the normal waking hours each day for four consecutive weeks. Participants
will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first), on the
evening prior to their next scheduled counseling session (one week later). Participants will
be randomized to Standard Care (SC) or CM using a random numbers table and advised of their
group assignment at the conclusion of visit 1. The appropriate schedule of payments (SC or
CM) will be discussed with all participants (see Table 1). Visit 1 takes approximately 1 hour
to complete, and participants will be scheduled to return for visit 2.

Visit 2 (Quit Day). Participants will complete self-report questionnaires on a laptop
computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. Visit 2 takes approximately 40 minutes to complete. Participants randomized
to the CM treatment will receive an additional payment if they self-report abstinence from
smoking since 10 p.m. the prior evening, and their expired is CO level is < 10 ppm (please
note that the less stringent cut-off of 10 ppm will be used to verify abstinence at the first
visit only, due to the recency of quitting). Participants who do not attend will be contacted
by phone to obtain their self-reported smoking status only.

Visit 3 (1 Week Post-Quit). Participants will complete self-report questionnaires on a laptop
computer; and expired carbon monoxide (CO) and weight will be measured in a private room to
ensure confidentiality. Visit 3 takes approximately 30 minutes to complete. Participants
randomized to the CM treatment will receive an additional payment if they self-report
continuous abstinence from smoking since the quit day and have an expired CO level of ≤ 6
ppm. Participants who do not attend will be contacted by phone to obtain their self-reported
smoking status.

Visit 4 (2 Weeks Post-Quit). Expired carbon monoxide (CO) and weight will be measured in a
private room to ensure confidentiality. The visit 4 assessment takes approximately 5 minutes
to complete. Participants randomized to the CM treatment will receive payment if they
self-report continuous abstinence from smoking since the quit date and have an expired CO
level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their
self-reported smoking status.

Visit 5 (3 Weeks Post-Quit). Expired carbon monoxide (CO) and weight will be measured in a
private room to ensure confidentiality. The visit 5 assessment will take approximately 5
minutes to complete. Participants randomized to the CM treatment will receive payment if they
self-report continuous abstinence from smoking since the quit date and have an expired CO
level of ≤ 6 ppm. Participants who do not attend will be contacted by phone to obtain their
self-reported smoking status.

Visit 6 (4 Weeks Post-Quit). Participants will complete self-report questionnaires on a
laptop computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. The visit 6 assessment will take approximately 50 minutes to complete. Upon
return of the smartphones, participants will be compensated based on the percentage of
completed random assessments. Participants who do not attend will be contacted by phone
and/or mail to request that the phone be returned by mail (postage paid envelopes will be
sent) or in-person at the next visit. When participants return the phone they will be
compensated according to the compensation schedule described above. Participants randomized
to the CM treatment will receive an additional payment if they self-report continuous
abstinence from smoking since the quit date and have an expired CO level of ≤ 6 ppm.
Participants who do not attend will be contacted by phone to obtain their self-reported
smoking status.

Visit 7 (8 Weeks Post-Quit). Participants will complete self-report questionnaires on a
laptop computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. Participants will receive a payment for completion of the in-person
assessments, which will take approximately 30 minutes to complete. Participants randomized to
the CM treatment will receive an additional payment if they self-report abstinence from
smoking over the past 7 days and have an expired CO level of ≤ 6 ppm. Participants who do not
attend will be contacted by phone to obtain their self-reported smoking status.

Visit 8 (12 Weeks Post-Quit). Participants will complete self-report questionnaires on a
laptop computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. Participants will receive a payment for completion of the in-person
assessments, which will take approximately 30 minutes to complete. Participants randomized to
the CM treatment will receive an additional payment if they self-report abstinence from
smoking over the past 7 days and have an expired CO level of ≤ 6 ppm. Participants who do not
attend will be contacted by phone to obtain their self-reported smoking status.

Visit 9 (26 Weeks Post-Quit Follow-Up). Participants will complete self-report questionnaires
on a laptop computer; and expired CO and weight will be measured in a private room to ensure
confidentiality. Participants will receive a payment for completion of the in-person
assessments, which will take approximately 40 minutes to complete. Saliva cotinine will also
be measured via NicAlert test strips to provide additional evidence of abstinence.
Participants who do not attend will be contacted by phone to obtain their self-reported
smoking status.

Inclusion Criteria:

1. are currently uninsured or receiving Medicaid benefits

2. earn a score ≥ 4 on the REALM indicating > 6th grade English literacy level

3. are willing to quit smoking 7 days from their first visit

4. are ≥ 18 years of age

5. have an expired CO level ≥ 8 ppm suggestive of current smoking

6. are currently smoking ≥ 5 cigarettes per day

7. are willing and able to attend 9 study visits.

Exclusion Criteria:

1. are unwilling to quit smoking 7 days from their first visit

2. have already quit smoking

3. earn a score <4 on the REALM indicating < 7th grade literacy level

4. produce an expired CO level < 8 ppm

5. are currently smoking < 5 cigarettes per day

6. are unwilling or unable to attend study visits

7. are < 18 years of age

8. are not uninsured or receiving Medicaid benefits