drugset / Trial / NCT01898195

Improving Adherence to Smoking Cessation Medication Among PLWHA

NCT01898195

Completed 158 enrolled NYU Langone Health
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-03
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule 1 mg

Indications