Personalized wellness intervention for smoking cessation in adults living with HIV

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

This study tests a personalized program to help adults with HIV quit smoking and see if it works better than standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Arizona (Academic / other)
• Locations: 2 sites (Phoenix, Arizona and 1 other locations)
• Trial ID: NCT04725617 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a 13-week personalized smoking cessation intervention for adults living with HIV who smoke. Participants will be randomly assigned to one of two behavioral health approaches, alongside a standard smoking cessation program that includes varenicline and counseling sessions. The study will assess the impact of these interventions on smoking cessation rates, sleep quality, and cardiovascular health markers. A total of 200 eligible participants will be recruited and monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who are living with HIV, smoke at least 5 cigarettes a day, and are motivated to quit smoking.

Not a fit: Patients with significant sleep disorders or those currently enrolled in other smoking cessation programs may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve smoking cessation rates and overall health outcomes for adults living with HIV.

How similar studies have performed: Previous studies have shown that integrated approaches addressing both smoking cessation and sleep health can be beneficial, suggesting potential success for this novel intervention.

Eligibility criteria

Inclusion Criteria:

1. Males and females 18 -75 years;
2. Documented HIV infection;
3. CD4+ T cell count ≥ 200 cells/mm3;
4. On stable antiretroviral therapy without intention of changing, or not on antiretroviral therapy with no immediate intention to start;
5. Smoke at least 5 cigarettes/day;
6. Report wanting to quit smoking in the next month;
7. 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);
8. Able to communicate in English and provide written informed consent for study procedures;
9. Able to use varenicline tartrate safely;
10. Will be residing in the geographic area for at least 10 months;
11. Willing to attend 8 in-person sessions and one 6-month follow up assessment.

Exclusion Criteria

1. Regular use of chewing tobacco, snuff, cigars, e-cigarettes, unless willing to stop;
2. Current enrollment or plans to enroll in another smoking cessation program or use other smoking cessation products for the duration of the study;
3. Women of childbearing potential who are pregnant, lactating, or likely to become pregnant during the trial and unwilling to use contraception during the study;
4. Unstable alcohol use that precludes reliable study participation as assessed by study physician;
5. Unstable drug use that precludes reliable study participation as assessed by study physician;
6. Unstable mental illness that precludes reliable study participation as assessed by study physician;
7. 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;
8. 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
9. 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);
10. Any prior history of seizure disorder within the past year;
11. 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;
12. Currently working night/rotating shift and/or use of a sleep medication, or a medication that could influence sleep;
13. Prior history of adult somnambulism;
14. Use of a sleep medication that will interfere with study results
15. Inability to complete any of the study tasks as determined by the investigators.

Where this trial is running

Phoenix, Arizona and 1 other locations

• Banner University Medical Center Phoenix — Phoenix, Arizona, United States (Recruiting)
• University of Arizona — Tucson, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Elizabeth Connick, MD — University of Arizona
• Study coordinator: Gabriela Montenegro

Conditions HIV; Sleep; Smoking Cessation; Cardiovascular Diseases