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

Smoking is a leading public health problem, especially for adults living with HIV (ALHIV), who have higher rates
of smoking and more cardiovascular disease than the general population. Poor sleep is more prevalent among
ALHIV, more prevalent among smokers, can be caused by smoking cessation attempts, predicts relapse to
former smoking patterns, and is linked to multiple comorbidities including cardiovascular disease. This study will prospectively test a novel sleep health intervention in ALHIV smokers to determine if it improves sleep health and enhances quit rates, and whether improvements in cognition and affect mediate the relationship between sleep health and smoking cessation.

Study phase: N/A

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

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 obstructive sleep apnea (apnea-hypopnea index (AHI) 5-14);

8.) Able to communicate in English and provide written informed consent for study procedures;

9.) Able to use varenicline safely;

10.) Will be residing in the geographic area for at least 10 months;

11.) Willing to attend 6 in-person sessions and one 6-month follow up assessment.

Primary disease category: HIV/AIDS & Infectious Disease

Sponsor: National Institutes of Health/National Institute of Drug Abuse (NIH/NIDA)

Protocol number: ALHIV & Smoking

Projected enrollment dates: July 2020 to March 2025

Official study title: Using Sleep Health to Optimize Smoking Cessation Treatment Response in HIV-Positive Adults