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Wellness Intervention for Smoking and HIV
Sponsor: University of Arizona
Summary
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).
Official title: Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-11-16
Completion Date
2025-09-28
Last Updated
2025-08-19
Healthy Volunteers
No
Interventions
Varenicline
Standard smoking cessation treatment.
Smoking Cessation Counseling
Standard smoking cessation treatment
Health Approach 1 to Reduce Smoking
Behavioral health intervention option 1
Health Approach 2 to Reduce Smoking
Behavioral health intervention option 2
Locations (2)
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States