Clinical Trial 23131

• Overview

  Study Title:

  Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living with HIV: A Feasibility Study

  Objective:

  1.1 Primary Objectives 1.1.1 Determine the feasibility of a smartphone-based HIV-specific behavioral smoking cessation intervention that can be delivered at the time of low dose computed tomography (LDCT), as measured by use of and engagement with the intervention. 1.1.2 Determine the adherence to LDCT in a study setting for PLWH who smoke. 1.2 Secondary Objectives 1.2.1 Determine the prevalence of positive LDCT screens and related follow-up procedures (which may include any of the following: (1) follow-up CT scan at an interval less than 12 months from the screening LDCT; (2) Positron emission tomography, PET /CT scan; (3) Transthoracic needle biopsy; (4) Bronchoscopy, with or without biopsy; (5) Surgical biopsy and/or resection) in PLWH who smoke. 1.2.2 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. 1.2.3 Obtain preliminary estimate of the proportion of participants who use prescribed nicotine replacement (self-reported) at 3-month visit. 1.3 Exploratory Objectives 1.3.1 Identify characteristics associated with PLWH who smoke and who are more likely to engage with an HIV-specific smoking cessation intervention. 1.3.2 Quantify LDCT screening-related study endpoints (i.e., incident lung cancers, emphysema, and other incidental findings [see Section 10.1]) in PLWH who smoke. 1.3.3 Compare LDCT screening-relevant patient reported outcomes (anxiety, insomnia, pain) at 3 and 6 months after LDCT to evaluate screening tolerability.

• Inclusion Criteria

  Key Inclusion Criteria:
  • Able to understand and willing to sign a written informed consent document.
  • HIV positive.
  • Receiving antiretroviral therapy and CD4 count at least 200 cells/µL within 6 months of registration (due to increased risk of LDCT false positivity with CD4 count > 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.22 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
  • Biochemically confirmed current smoker (exhaled CO ≥7 parts per million).
  • Meets USPSTF criteria for LDCT (age 50-80 and ≥20 pack-years smoking)43 or high-risk but not meeting USPSTF (age 45-49 and ≥20 pack-years smoking).
  • Possession of a smartphone that can support PSF-M (>95% of subjects had eligible phones in prior trials although we will include specific study screening questions assessing for adequate smartphone for the intervention). The screening questions can be located in PSF-M app user manual.
  • Sufficient literacy.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key 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 (CT) 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 CT scan in the previous 12 months.
  • Other exclusion criteria may apply.

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