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.