Actively Recruiting
Wellness Intervention for Smoking and HIV
Led by University of Arizona · Updated on 2025-08-19
200
Participants Needed
2
Research Sites
201 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
U
University of Delaware
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Wellness Intervention for Smoking and HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 75 years
- Documented HIV infection
- CD4+ T cell count of at least 200 cells/mm3
- On stable antiretroviral therapy without plans to change, or not on therapy with no immediate plans to start
- Smoking at least 5 cigarettes per day
- Intending to quit smoking within the next month
- No sleep disorders except insomnia or mild to moderate obstructive sleep apnea (STOP-Bang score 4 or less; apnea-hypopnea index less than 30)
- Able to communicate in English and provide written informed consent
- Able to use varenicline tartrate safely
- Planning to reside in the study area for at least 10 months
- Willing to attend 8 in-person sessions and a 6-month follow-up assessment
You will not qualify if you...
- Regular use of chewing tobacco, snuff, cigars, or e-cigarettes unless willing to stop
- Current enrollment or plans to join another smoking cessation program or use other cessation products during the study
- Women of childbearing potential who are pregnant, breastfeeding, or likely to become pregnant and unwilling to use contraception during the study
- Unstable alcohol use that prevents reliable participation
- Unstable drug use that prevents reliable participation
- Unstable mental illness that prevents reliable participation
- History of suicide attempt within 2 years or current suicidal thoughts
- Untreated or unstable moderate to severe depression (PHQ-9 score 15 or higher)
- Serious or unstable disease within past 6 months (e.g., cancer, seizure disorder, end-stage liver or kidney disease, uncontrolled diabetes, pulmonary disease needing oxygen)
- History of seizure disorder within past year
- Unstable cardiac condition within past 6 months or unsafe EKG findings
- Working night or rotating shifts or using sleep medications that affect sleep
- History of adult sleepwalking
- Use of sleep medications interfering with study results
- Unable to complete study tasks as determined by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
Research Team
G
Gabriela Montenegro
CONTACT
J
Jose Elizondo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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