Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults
The investigators propose to use a parallel group, randomized controlled trial to test the efficacy of a 13-week personalized approach to reducing smoking intervention versus a second approach using a different health intervention on smoking cessation, healthy sleep metrics, and biomarkers of cardiovascular risk in a sample of 200 treatment-seeking smokers who are adults living with HIV (ALHIV). To enroll in the study, treatment-seeking ALHIV smokers will undergo phone and in-person study eligibility assessments, including a history, physical examination, screening laboratory tests, and an overnight in-home objective sleep assessment. Eligible subjects (N=200) will be randomized to the 13-week Approach 1 (N=100) or Approach 2 (N=100) condition. All subjects will receive a 12-week course of varenicline (beginning in week 2) and 8 individual 15-minute smoking cessation counseling sessions \[weeks 1, 2, 3 (target quit date), 5, 7, 9, 11, 13\]. At each in-person counseling session, 30-45 minutes of Approach 1 or Approach 2 counseling will be provided as well. While receiving varenicline, the study team will monitor for side effects and changes to blood pressure at each study visit for safety reasons. Study measures are collected at all time points including EOT (week 13), and 6-month follow-up (6MFU).
• Males and females 18 -75 years;
• Documented HIV infection;
• CD4+ T cell count ≥ 200 cells/mm3;
• On stable antiretroviral therapy without intention of changing, or not on antiretroviral therapy with no immediate intention to start;
• Smoke at least 5 cigarettes/day;
• Report wanting to quit smoking in the next month;
• Have no sleep disorders (with the exception of insomnia or mild to moderate obstructive sleep apnea (STOP-Bang score of 4 or less; apnea-hypopnea index (AHI) of less than 30);
• Able to communicate in English and provide written informed consent for study procedures;
• Able to use varenicline tartrate safely;
⁃ Will be residing in the geographic area for at least 10 months;
⁃ Willing to attend 8 in-person sessions and one 6-month follow up assessment.