RecruitingNot ApplicableNCT04725617

Wellness Intervention for Smoking and HIV

Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults


Sponsor

University of Arizona

Enrollment

200 participants

Start Date

Nov 16, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a smoking cessation program with sleep wellness support improves quit rates in people living with HIV who smoke. People with HIV smoke at much higher rates than the general population, and poor sleep may contribute to failed quit attempts. **You may be eligible if:** - You are between 18 and 75 years old - You are living with HIV - You smoke at least 5 cigarettes per day and want to quit within the next month - Your immune system is reasonably stable (CD4 count at or above 200 cells/mm³) - You speak English and can attend in-person sessions - You plan to remain in the area for at least 10 months **You may NOT be eligible if:** - You are pregnant or likely to become pregnant during the study - You have a serious unstable medical condition (including cancer, seizures, end-stage kidney or liver disease) - You have severe untreated depression or active suicidal thoughts - You are currently in another smoking cessation program - You have a serious sleep disorder or currently work night shifts - You have had an unstable heart condition within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVarenicline

Standard smoking cessation treatment.

BEHAVIORALSmoking Cessation Counseling

Standard smoking cessation treatment

BEHAVIORALHealth Approach 1 to Reduce Smoking

Behavioral health intervention option 1

OTHERHealth 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

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NCT04725617


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