Overview

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.

Eligibility

Inclusion Criteria:

• Able to understand and willing to sign a written informed consent document
• HIV positive. Documentation of HIV-1 infection by means of any one of the following:
  • 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;
  • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.

        Note: The term "licensed" refers to a kit that has been certified or licensed by an
        oversight body within the participating country and validated internally (e.g., U.S. Food
        and Drug Administration [FDA]).
        WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention)
        guidelines mandate that confirmation of the initial test result must use a test that is
        different from the one used for the initial assessment. A reactive initial rapid test
        should be confirmed by either another type of rapid assay or an E/CIA that is based on a
        different antigen preparation and/or different test principle (e.g., indirect versus
        competitive), or a Western blot or a plasma HIV-1 RNA viral load
          -  Receiving antiretroviral therapy and CD4 count at least 200 cells/uL within 6 months
             of registration (due to increased risk of LDCT false positivity with CD4 count <
             200cells/uL)
          -  Age 45-80 years. This age restriction reflects lung cancer risk and appropriateness
             for lung cancer screening; in epidemiologic studies lung cancer emerges 5-10 years
             earlier in PLWH, and therefore this is an appropriate risk group for screening.
             Although younger persons are likely to benefit more from smoking cessation as a lung
             cancer prevention measure, the risk/benefit ratio associated with lung cancer
             screening is unlikely to be optimal at ages < 45 years for PLWH
          -  Biochemically confirmed current smoker (exhaled carbon monoxide [CO] >= 7 parts per
             million)
          -  Meets United States Preventive Services Task Force (USPSTF) criteria for LDCT (age
             50-80 and >= 20 pack-years smoking) or high-risk but not meeting USPSTF (age 45-49 and
             >= 20 pack-years smoking)
          -  Possession of a smartphone that can support Positively Smoke Free Mobile (PSF-M) (>
             95% of subjects had eligible phones in prior trials although researchers will include
             specific study screening questions assessing for adequate smartphone for the
             intervention)
          -  Sufficient literacy; >= 4 on the Rapid Estimate of Adult Literacy in Medicine-Short
             Form (REALM-R) literacy scale
        Exclusion Criteria:
          -  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
          -  History of lung cancer
          -  Pregnant women are excluded from this study because computed tomography introduces
             radiation exposure and may have teratogenic effects
          -  Women who are breastfeeding (the safety of nicotine replacement therapy has not been
             established with breastfeeding)
          -  Received a chest computed tomography scan in the previous twelve months