Improving Adherence to Smoking Cessation Medication Among PLWHA
Completed · Not applicable
Conditions studied: Tobacco Use Cessation
In brief
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.
Key facts
- Study ID
- NCT01898195
- Run by
- NYU Langone Health
- People needed
- 158
- Starts
- 2013-03-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-08-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Current patient at one of two SLR CCC clinics with a designated physician (had intake visit and enrolled into clinic)
- Age 18 years or older;
- Current or regular smoker (>5 cigarettes per day);
- Carbon Monoxide (CO) monitor reading of >8 ppm;
- Willingness to set a quit date;
- Able to conduct activities in English;
- Ability to provide informed consent;
- Willingness to carry/use a cell phone; AND
- Eligible to take varenicline as determined by the patient's primary care provider
You may not qualify if…
- Unstable cardiovascular disease (e.g. uncontrolled blood pressure, unstable angina, or myocardial infarction in the past 4 weeks);
- Current homicidal or suicidal ideation, history of suicidal ideation, or history of psychosis;
- Has a serious or untreated psychiatric illness (major depression, bipolar or schizophrenia);
- Severe renal impairment (defined as having a creatinine clearance < 30mL/min);
- Currently using smokeless tobacco;
- Currently using FDA-approved smoking cessation medication or other smoking cessation treatment and or participating in another smoking cessation program;
- Active drug use identified by a score of 6 or above on DAST-10 Drug Abuse Screening Test;
- 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
- Pregnant or nursing; AND/OR
- Has a cognitive impairment that would preclude giving consent.
Where it is running
- Spencer Cox Center for Health — New York, New York, United States
Full record on ClinicalTrials.gov
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