Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
Start Date
3/22/2023
Completion Date
8/31/2027
Summary
This clinical trial evaluates the usefulness of using a smartphone-based HIV-specific smoking cessation intervention at the time of lung cancer screening in helping people living with HIV quit smoking. Positively Smoke Free - Mobile may help patients with HIV quit smoking.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the feasibility of a smartphone-based human immunodeficiency virus (HIV)-specific behavioral smoking cessation intervention that can be delivered at the time of low dose non contrast enhanced lung computed tomography (LDCT), as measured by use of and engagement with the intervention. II. Determine the adherence to LDCT in a study setting for persons living with HIV (PLWH) who smoke. SECONDARY OBJECTIVES: I. Determine the prevalence of positive LDCT screens and related follow-up procedures (which may include any of the following: follow-up computed tomography \[CT\] scan at an interval less than 12 months from the screening LDCT; (2) positron emission tomography (PET) with or without CT scan; (3) transthoracic needle biopsy; (4) bronchoscopy, with or without biopsy; (5) surgical biopsy and/or resection) in PLWH who smoke. II. Quantify the proportions of persons who quit smoking at 3 and 6 months after using the HIV-specific smoking cessation intervention and receiving LDCT screening. III. Obtain preliminary estimate of the proportion of participants who use prescribed nicotine replacement (self-reported) at 3-month visit. EXPLORATORY OBJECTIVES: I. Identify characteristics associated with PLWH who smoke who are more likely to engage with an HIV-specific smoking cessation intervention. II. Quantify LDCT screening-related study endpoints (i.e. incident lung cancers, emphysema, and other incidental findings in PLWH who smoke. III. Compare LDCT screening-relevant patient reported outcomes (anxiety, insomnia, pain) at 3 and 6 months after LDCT to evaluate screening tolerability. OUTLINE: Patients use the smartphone application, Positively Smoke Free - Mobile, for 42 days. Patients also receive nicotine replacement therapy for 12 weeks. Within 60 days of study registration, patients undergo LDCT. After completion of study intervention, patients are followed up at 3, 6, and 12 months.
Eligibility Criteria
Age Range: 45 years to 80 years
Interventions
Computed Tomography
Smoking Cessation Intervention
Conditions
Locations
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
George Washington University
Washington D.C., District of Columbia 20052
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York 10010
United States
Mount Sinai Hospital
New York, New York 10029
United States
Montefiore Medical Center
The Bronx, New York 10461
United States
The Ohio State University James Cancer Hospital
Columbus, Ohio 43221
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States