Status:
RECRUITING
Wellness Intervention for Smoking and HIV
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
University of Delaware
Conditions:
HIV
Sleep
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed Description
Cigarette smoking among adults living with HIV (ALHIV) is a significant public health problem, leading to substantial morbidity and mortality in this population. Existing smoking cessation interventio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04725617
Start Date
November 16 2021
End Date
September 28 2025
Last Update
August 19 2025
Active Locations (2)
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1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
University of Arizona
Tucson, Arizona, United States, 85724