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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Undergo LDCT
Use Positively Smoke Free - Mobile
UC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGGeorge Washington University
Washington D.C., District of Columbia, United States
RECRUITINGRate of adherence to Positively Smoke Free - Mobile (PSF-M)
Adherence is defined by meeting at least one of the following: logging into the application at least 10 of 42 days; watching of \>= 4 of 8 video sessions; AND meeting the definition of Engagement with the intervention as defined by at least one of the following: use of the "HELP" button at least once; OR responding to the text messaging "check-in" at least once. Will be summarized as the proportion of participants who meet the criteria as defined above among all the participants who are enrolled in the study. A two-sided 95% confidence interval will also be reported. Proportion of engagement will be calculated similarly. Will also classify levels of adherence with the intervention and categorize these levels as no adherence, low-level adherence, and high-level engagement. The proportion of participants that fall under each category will be calculated.
Time frame: Up to 42 days
Number of participants who complete the low dose chest CT scan within 60 days of enrollment
Participants will complete a low dose CT scan for screening purposes
Time frame: Within 60 days of study registration
Number of positive screening scans
Defined as Lung Computed Tomography Screening Reporting and Data System (Lung-RADS 3) or higher and follow-up procedures. The estimate of prevalence of "positive LDCT screen" (Lung-RADS \> 3) will be computed as "total number of participants who test positive/Total number of participants enrolled × 100". Bivariate association between LDCT screening status and age category, number of smoking pack years will be evaluated separately using either Chi-square test or Fisher's exact test (for sparsely distributed cells). Prevalence of lung cancer will be calculated in a similar manner.
Time frame: 12 months
Total number of participants with confirmed smoking cessation
As confirmed by exhaled carbon monoxide (CO) testing for assessment of long-term impact of smoking cessation interventions.
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Masking
NONE
Enrollment
100
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGWeill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGThe Ohio State University James Cancer Hospital
Columbus, Ohio, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
RECRUITING...and 1 more locations
Time frame: At 3 months and 6 months
Number of cigarettes smoked per day
Smoking quantity (daily cigarette consumption)
Time frame: At 3 months
Number of participants reporting anxiety related symptoms (concentration problems, memory problems, insomnia and anxiety) on the NCI PROCTCAE
Acceptability of both PSF-M and LDCT as rated by subject self-report
Time frame: At 3 months
Number of participants using nicotine replacement therapy at 3 months
The proportion of participants who use nicotine replacement at 3 months will be computed as "total number of participants with self-reported nicotine replacement usage/total number of participants enrolled". Bivariate association between nicotine usage status and categorical variables will be tested for statistical significance using the Chi-square or Fisher's exact test. Difference in continuous covariates with regards to nicotine usage status will be tested for statistical significance using Kruskal-Wallis test. In each of the aforementioned analysis that involves estimating proportions, a two-sided 95% confidence interval will also be reported.
Time frame: At 3 months