Improving Adherence to Smoking Cessation Medication Among PLWHA

To accomplish the study's aims the investigators propose a three phase study: PHASE 1)
Formative phase (n=40) to pretest text messages and to explore barriers to cessation and
adherence to cessation medication; PHASE 2) a Pretest phase (n=10) to test and revise the
intervention components and to assess design issues that may emerge, including those
associated with contacting subjects via cell phone, participant capacity to view text
messages, timing and content of text messaging, and use of the eCAPs system; and PHASE 3) a
Pilot randomized control trial (RCT) in which the investigators will randomize 190
participants, recruited at St. Luke's Roosevelt Comprehensive Care Clinics, to a three-arm
study that compares: 1) Standard care (SC), which includes receiving varenicline and brief
counseling; 2) SC + daily text messages medication reminders (TxT); or 3) SC + TxT + seven
sessions of cell-phone-delivered, adherence-focused behavioral therapy (ABT). Text messages
will include medication reminders and motivational messages related to adherence and
maintaining abstinence. Participants in all three arms will receive varenicline for 12
weeks. To have a total sample of 150 subjects through the end of treatment at 12 weeks, or
50 subjects in each arm, the investigators will randomize 190 patients to account for a 20%
attrition rate. Subjects will be surveyed at six time points including the baseline
assessment.

PHASE 1: FORMATIVE EVALUATION Focus groups with patients. Focus groups (lasting from 60 to
90 minutes) will be conducted with HIV+ smokers. To recruit patients for Phase 1, research
assistants will approach all individuals within the clinic setting to screen for tobacco
use. If they are a current smoker they will be asked if they wish to participate in a
scheduled focus group at a convenient time. The research assistants will recruit 80 patients
and expect to complete 4 focus groups with 10 participants in each for a total of 40
participants. The main aims of these focus groups are: 1) to obtain feedback on the text
message library to determine which messages will be most acceptable and useful, and how
often the patients would like to receive messages; 2) to assess comfort with using the
pre-paid phone to receive and send messages; 3) to assess confidentiality concerns regarding
receiving the text messages and how the patients may be edited to avoid loss of
confidentiality; and 4) to explore attitudes and beliefs about varenicline, previous
experiences using varenicline, potential challenges with adhering to varenicline, and
similarly to explore experiences with past quit attempts and barriers (individual, social,
structural) to quitting.

The focus groups will follow written guides. In addition to pre-specified domains drawn from
the research questions above, the group facilitator will also listen for and explore
emergent topics. Focus groups will be audio-recorded and two research assistants will take
notes during each group discussion. All audio recordings will be transcribed verbatim, and
transcripts will be supplemented with notes taken during the focus group to ensure accuracy.
These transcripts will be analyzed for both pre-determined and emergent themes.

PHASE 2: PRE TEST Prior to starting the RCT the investigators will pre-test the intervention
components (ARM 3) to assess study design issues that may emerge, including those associated
with contacting subjects via cell phone, participant capacity to view text messages, timing
and content of text messaging, and use of the eCAPs system. Ten patients will be enrolled
for this phase with a target sample of 6 at end-of-treatment. Quantitative data collection,
described below, will follow. The investigators will also conduct post-intervention in-depth
interviews with all enrolled subjects to obtain feedback on the components' utility,
acceptability, and safety. The research team and consultants will meet after this pilot test
to make adjustments to the intervention components prior to the RCT.

PHASE 3: PILOT RCT Overview. This phase of research will compare three smoking cessation
interventions that were tested and refined in Phases 1 and 2. A total of 190 PLWHA who are
patients at CCC will be screened for this phase with a target sample of 150 at
end-of-treatment. The investigators will use a randomized controlled trial design. This is
not a formal efficacy trial but a test of the interventions feasibility, safety, and
acceptability. Additionally the study will provide preliminary evidence of efficacy of the
intervention components with respect to the study's main endpoints: a) adherence to
varenicline and b) smoking abstinence at 12 and 24 weeks. This data will inform the design
of a larger R01.

Intervention conditions ARM 1: Standard Care (SC). All CCC patients are screened for tobacco
use during their routine visits and offered a referral to the New York State (NYS) Quitline.
As part of current standard care, all trial participants will receive a self-help
information sheet, tailored to HIV+ smokers with frequently asked questions about using
varenicline, and a wallet card with the State Quitline number. All subjects will be offered
varenicline for 12 weeks. All study participants will be asked whether they prefer to
receive phone calls and text messages from the study staff via their own phone or a phone
provided by the study, at no cost to the participant. If they choose the latter option, they
will be given a pre-paid cell phone for 3 months. Subjects in the SC arm will receive phones
to facilitate their ability to call the Quitline for assistance and to enable us to send
follow-up appointment reminders via text message. Each pre-paid phone will have an allowance
of 200 minutes and unlimited text messages per month. The investigators will instruct
participants to use their minutes only toward tobacco treatment or study related purposes.
The investigators will track minutes used and if minutes are used out, the investigators
will add just enough minutes when they need to contact the subject.

Varenicline therapy: All patients enrolled in the study will be given a 12-week supply of
varenicline. The dose will be 0.5 mg/day for 3 days followed by 0.5 mg BID for the next 4
days, and 1 mg BID after first 7 days. The research assistant will explain the use of the
medication, review potential side effects, and provide each subject with a wallet size
instruction card that will have the dosing schedule and information on how to use the
medication. Subjects will receive the medication at a follow-up study visit one week after
they are consented. Subjects will receive a three-week supply of varenicline and return at
week 4 of the study (timed from the first week they receive the medication). At the week 4
visit they will receive another 4 weeks of medication and will be asked to return at week 8
to receive the final 4 weeks of medication. More than one eCAP bottle will be distributed,
depending on the dose of medication and the week of treatment.

ARM 2: SC + Text messages (TxT). Subjects randomized to this arm will receive SC plus twice
daily text messaging to remind them to take their medication. Participants will begin
receiving text messages the day before they start taking medication, and text messaging will
continue for 12 weeks. The text messages are designed to convey relevant information to the
subjects while permitting a protective ambiguity. For example, none of the messages
transmitted to participants will use the terms HIV or AIDS. In addition, each text message
will have the tag "ACT" (Adherence to Cessation Treatment) indicating that it is coming from
the study. Participants will receive one medication adherence reminder message and one
motivational message regarding tobacco cessation each day. RTI staff will monitor the
delivery of the text messages. If participants do not receive text messages for two
consecutive days, the study research assistant will call them to assess reasons for message
failure. During the study, participants may opt out of receiving any category of messages by
contacting the study research assistants and informing him/her of their request. Requests to
decline a specific message type or to fully withdraw from the study will be handled promptly
and subjects will stop receiving messages within 48 hours of submitting their request to the
study research assistant. The investigators will use both symbols and text to accommodate
low literacy levels.

ARM 3: SC + TxT + adherence-focused motivational and behavioral therapy (ABT). In addition
to SC and TxT, the behavioral intervention group will receive seven proactive
cell-phone-delivered counseling sessions over a 6-week period. Drs. Shelley and Krebs have
adapted the telephone counseling manual that was developed and tested by Dr. Sherman which
was based on Dr. David Kalman's "Treatment Manual for Extended Counseling to Treat Tobacco
Addiction,". The draft manual will be reviewed by Drs. Sherman, Wolfe, and Morgenstern and
then revised prior to the Phase 2 pretest. The research team will meet again to further
revise the manual based on findings from the Phase 2 post-intervention qualitative
interviews. The content of the manual combines the principles of Cognitive Behavioral
Therapy (CBT) with Motivational Interviewing (MI) techniques, both of which have been
applied to smoking cessation with promising results.

Inclusion Criteria:

1. Current patient at one of two SLR CCC clinics with a designated physician (had intake
visit and enrolled into clinic)

2. Age 18 years or older;

3. Current or regular smoker (>5 cigarettes per day);

4. Carbon Monoxide (CO) monitor reading of >8 ppm;

5. Willingness to set a quit date;

6. Able to conduct activities in English;

7. Ability to provide informed consent;

8. Willingness to carry/use a cell phone; AND

9. Eligible to take varenicline as determined by the patient's primary care provider

Exclusion Criteria:

1. Unstable cardiovascular disease (e.g. uncontrolled blood pressure, unstable angina,
or myocardial infarction in the past 4 weeks);

2. Current homicidal or suicidal ideation, history of suicidal ideation, or history of
psychosis;

3. Has a serious or untreated psychiatric illness (major depression, bipolar or
schizophrenia);

4. Severe renal impairment (defined as having a creatinine clearance < 30mL/min);

5. Currently using smokeless tobacco;

6. Currently using FDA-approved smoking cessation medication or other smoking cessation
treatment and or participating in another smoking cessation program;

7. Active drug use identified by a score of 6 or above on DAST-10 Drug Abuse Screening
Test;

8. Alcohol dependence or risk drinking identified by a score of 5 or above for men and 4
or above for women on AUDIT-C Alcohol Use Disorders Identification Test

9. Pregnant or nursing; AND/OR

10. Has a cognitive impairment that would preclude giving consent.