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

Description

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.

Conditions

HIV Infection, Tobacco-Related Carcinoma

Study Overview

Study Details

Study 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.

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

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

Condition
HIV Infection
Intervention / Treatment

-

Contacts and Locations

La Jolla

UC San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Washington

George Washington University, Washington, District of Columbia, United States, 20052

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10461

New York

Weill Cornell Medicine - Cornell Clinical Trials Unit, New York, New York, United States, 10010

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Houston

University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States, 77030

Seattle

Virginia Mason Medical Center, Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AIDS Malignancy Consortium,

Keith M Sigel, PRINCIPAL_INVESTIGATOR, AIDS Malignancy Consortium

Study Record Dates

2026-05-31