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

Recruiting now · Not applicable

Conditions studied: HIV Infection, Tobacco-Related Carcinoma

In brief

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.

Key facts

Study ID: NCT04949464
Run by: AIDS Malignancy Consortium
People needed: 100
Starts: 2023-03-22
Expected to finish: 2027-08-31
Last updated by the study team: 2026-06-05

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
George Washington University — Washington D.C., District of Columbia, United States (enrolling)
Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
Weill Cornell Medicine - Cornell Clinical Trials Unit — New York, New York, United States (enrolling)
Mount Sinai Hospital — New York, New York, United States (enrolling)
Montefiore Medical Center — The Bronx, New York, United States (enrolling)
The Ohio State University James Cancer Hospital — Columbus, Ohio, United States (enrolling)
Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
Virginia Mason Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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