NCT04725617 · University of Arizona
Wellness Intervention for Smoking and HIV
((WISH))
What this study is about
The investigators propose to use a parallel group, randomly assigned controlled trial to test the effectiveness 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 randomly assigned 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).
View original scientific description
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).
Interventions
DRUG
Varenicline
Standard smoking cessation treatment.
BEHAVIORAL
Smoking Cessation Counseling
Standard smoking cessation treatment
BEHAVIORAL
Health Approach 1 to Reduce Smoking
Behavioral health intervention option 1
OTHER
Health Approach 2 to Reduce Smoking
Behavioral health intervention option 2
Primary outcome measures
Change in smoking cessation
Time frame: Change in smoking cessation from baseline to end of 13-week timeline and 6 month follow up
Cessation of smoking determined via self-report and biochemical verification of carbon monoxide breath test and urine cotinine.
Change in sleep duration
Time frame: Change in sleep duration from baseline to end of 13-week timeline and 6 month follow up
Amount of sleep per night, assessed with sleep diary and actigraphy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Regular use of chewing tobacco, snuff, cigars, e-cigarettes, unless willing to stop;
- Current enrollment or plans to enroll in another smoking cessation program or use other smoking cessation products for the duration of the study;
- Women of childbearing potential who are pregnant, lactating, or likely to become pregnant during the trial and unwilling to use contraception during the study;
- Unstable alcohol use that precludes reliable study participation as assessed by study physician;
- Unstable drug use that precludes reliable study participation as assessed by study physician;
- Unstable mental illness that precludes reliable study participation as assessed by study physician;
- A history of a suicide attempt within the last two years, and/or current nonspecific suicidal thoughts as defined by the Columbia Suicide Severity Rating Scale;
- Unstable or untreated moderate or severe depression as assessed by the Patient Health Questionnaire 9 (PHQ-9) scale. A participant with a score of ≥ 15 will be referred to one of the study's mental health clinicians (Dr. Michael Grandner or Dr. Susan Gorovoy) for further assessment of their depression
- Serious or unstable disease within the past 6 months (e.g., cancer, seizure disorder, end-stage liver disease, end-stage renal disease, uncontrolled diabetes, pulmonary disease requiring oxygen);
- Any prior history of seizure disorder within the past year;
- Unstable cardiac condition (i.e., angina, myocardial infarction, or coronary angioplasty) within the past 6 months or a clinically significant EKG that may present a health or safety risk as assessed by the study physician;
- Currently working night/rotating shift and/or use of a sleep medication, or a medication that could influence sleep;
- Prior history of adult somnambulism;
- Use of a sleep medication that will interfere with study results
- Inability to complete any of the study tasks as determined by the investigators.
Where
- Phoenix, Arizona
- Tucson, Arizona
Collaborators
University of Delaware
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations