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.
Able to understand and willing to sign a written informed consent document
Documentation of HIV diagnosis in the medical record by a licensed health care provider;
Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis [PrEP] or post-exposure prophylaxis [PEP]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;
HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating > 1000 RNA copies/mL;
Receiving any other smoking cessation interventions currently or within the prior 30 days
Contraindication to nicotine replacement therapy
Pneumonia or serious lung infection in prior 12 weeks
Uncontrolled intercurrent illness including, but not limited to, ongoing or active major infection, malignant tumors (unless these tumors were: (a) completely resected basal cell or squamous cell skin carcinomas or (b) in-situ squamous cell carcinoma of the cervix or anus), or any other major uncontrolled comorbid condition that would limit life expectancy or psychiatric illness/social situations that would limit compliance with study requirements
Single group
Computed Tomography
Procedure/SurgeryUndergo LDCT
Smoking Cessation Intervention
BehavioralUse Positively Smoke Free - Mobile
Rate 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.
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
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.
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.
Number of cigarettes smoked per day
Smoking quantity (daily cigarette consumption)
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
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AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
