Improving Adherence to Smoking Cessation Medication Among PLWHA
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Smoking rates among individuals living with HIV/AIDS range between 47% and 65%, a prevalence
that is roughly three times the rate of the general population. This elevated prevalence is
alarming given the increased likelihood of numerous adverse health outcomes experienced by
HIV-positive smokers. Cigarette smoking is associated with greater levels of HIV-related
symptom burden and appears to decrease the effectiveness of HAART as assessed by both viral
load and CD4 counts (Vidrine 2009, Marshall 2009, Vidrine 2007, Miguez-Burbane 2005). PLWHA
who smoke are also at increased risk of infections and noninfectious pulmonary complications
and both AIDS-associated and non-AIDS-associated malignancies compared to nonsmokers. This
study will refine and pilot test a theory-driven smoking cessation intervention that enhances
existing behavioral approaches by testing the impact of text message reminders to take
varenicline and the feasibility and additional impact of including adherence-focused
behavioral cessation counseling. The investigators propose to randomize 190 participants,
recruited from three HIV/AIDS clinic, to a three arm pilot study that compares: 1) Standard
Care (SC), 2) SC + text message reminders, and 3) SC + text message reminders + cell
phone-delivered adherence-focused behavioral therapy (ABT). Participants in all three arms
will receive varenicline for 12 weeks. The primary outcomes are adherence to varenicline and
biochemically validated smoking abstinence at 12 weeks and 3-month follow-up from the time of
study enrollment.
Phase:
N/A
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health