Wellness Intervention for Smoking and HIV

Launched by UNIVERSITY OF ARIZONA · Jan 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying ways to help adults living with HIV who smoke to quit smoking and improve their sleep and heart health. Researchers are comparing two different methods of support over 13 weeks to see which is more effective for helping participants stop smoking. To be eligible for the study, participants must be between 18 and 75 years old, have a confirmed HIV infection with stable health, smoke at least five cigarettes a day, and want to quit smoking within the next month. They also need to be able to attend in-person sessions and have no major sleep disorders.

Participants in the trial will receive medication called varenicline to help with quitting smoking, along with eight counseling sessions to provide support and guidance. Throughout the trial, the research team will make sure to monitor participants' health and any side effects from the medication. This study is actively recruiting participants, and it could be a great opportunity for those looking to quit smoking while also taking care of their overall health.

Gender

ALL

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.