Using smartphone support to help people with HIV quit smoking during lung cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the feasibility of a smartphone-based smoking cessation intervention specifically designed for individuals living with HIV, delivered concurrently with lung cancer screening via low dose computed tomography (LDCT). The study aims to measure participant engagement with the intervention and adherence to LDCT screening. Additionally, it seeks to assess the prevalence of positive LDCT screens and the effectiveness of the intervention in helping participants quit smoking at 3 and 6 months post-intervention. The trial also explores characteristics that may influence engagement with the smoking cessation program.

Why it matters

Who can join: the full rules

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

Where it's running

• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• George Washington University
  Washington D.C., District of Columbia, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Weill Cornell Medicine - Cornell Clinical Trials Unit
  New York, New York, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Keith M Sigel — AIDS Malignancy Consortium
• Study coordinator: Keith Sigel
• Email: Keith.Sigel@MSSM.edu
• Phone: (212) 659-8551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.