Clinical Research Directory

Trained LHWs will oversee the screening and brief intervention procedures (i.e., the 5As). A culturally acceptable standardized form will be integrated into intake procedures within the HIV that will allow for the documentation and results of using the 5As. The first "A" will be the screening question where the LHW will "Ask" study participants about smoking. When a participant reports being a smoker, the LHW will proceed to the next 3 "A"s (Advise, Assess, Assist). These 3As will constitute the brief intervention. The LHW will utilize motivational enhancing discussion between the study participant with a focus on increasing insight and awareness regarding smoking and motivation toward behavioral change. For those participants who are motivated for treatment, a referral will be made to a clinic nurse practitioner for evaluation for treatment with varenicline.

Referral to treatment with varenicline will be provided to those identified as needing more than a brief intervention. Participants will initiate medication treatment with varenicline for smoking cessation with a quit date scheduled for day 8 following first study dose of the medication. Participants will meet with the study clinician at baseline who will provide medical clearance and sign off on prescription orders. All medication will be provided to participants by the study team. Participants will receive a weekly supply of medication for the first four weeks to ensure proper dosing and monitor for adverse events. For the subsequent 8 weeks, participants will return every 4 weeks to receive the next month's supply of medication. Dosage adjustments will be permitted in an effort to control adverse effects throughout the trial. This will allow us to balance internal validity with good clinical practice. Varenicline will be dosed in accordance with package labeling.