Actively Recruiting
Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
Led by AIDS Malignancy Consortium · Updated on 2026-06-05
100
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
AIDS Malignancy Consortium
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a smartphone-based, HIV-specific behavioral smoking cessation program called Positively Smoke Free - Mobile in people living with HIV (PLWH) who smoke. The study aims to assess the feasibility of delivering this intervention alongside low dose non-contrast lung CT scans (LDCT) to help patients quit smoking and to monitor adherence to lung cancer screening in this population. Secondary goals include measuring smoking cessation rates, nicotine replacement use, and lung screening outcomes such as lung cancer and other findings. Participants will use the Positively Smoke Free - Mobile app for 42 days and receive nicotine replacement therapy for 12 weeks. Within 60 days of enrolling, they will undergo a low dose chest CT scan for lung cancer screening. After completing the intervention, participants will be followed up at 3, 6, and 12 months to assess smoking status, screening results, and patient-reported outcomes like anxiety, insomnia, and pain. During the study, researchers will track how well participants engage with the app and complete the lung CT scan within the specified timeframe. Smoking cessation will be measured at 3 and 6 months, along with nicotine replacement use. Safety and tolerability of lung screening will be evaluated through patient questionnaires on symptoms such as anxiety and concentration problems. The study lasts up to one year after intervention completion, providing ongoing monitoring of lung health and smoking behavior.
CONDITIONS
Brief Title
Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign a written informed consent document
- HIV positive confirmed by medical record, antiretroviral therapy prescription, HIV RNA test, or licensed HIV antibody assay
- Receiving antiretroviral therapy with CD4 count of at least 200 cells/uL within 6 months
- Age between 45 and 80 years
- Biochemically confirmed current smoker with exhaled carbon monoxide of 7 parts per million or higher
- Meets lung cancer screening criteria: age 50-80 with 20 or more pack-years smoking or age 45-49 with 20 or more pack-years
- Owns a smartphone capable of supporting the Positively Smoke Free Mobile app
- Sufficient literacy with a score of 4 or higher on the REALM-R literacy scale
You will not qualify if you...
- Receiving other smoking cessation treatments currently or within the last 30 days
- Contraindication to nicotine replacement therapy
- Pneumonia or serious lung infection within the past 12 weeks
- Uncontrolled major illness or infection, certain malignant tumors, or psychiatric/social issues limiting study compliance
- History of lung cancer
- Pregnant or breastfeeding women
- Received chest CT scan within the previous 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days for the smartphone intervention and 12 weeks for nicotine replacement therapy
Participants use a smartphone application for smoking cessation and receive nicotine replacement therapy.
1 baseline visit and follow-up visits during treatment as needed
Duration - Within 60 days of study registration
Participants undergo low dose computed tomography (LDCT) screening for lung cancer within 60 days of enrollment.
1 visit for LDCT screening (in-person)
Duration - Up to 12 months after intervention
Participants are followed up to assess smoking cessation, screening outcomes, and patient-reported symptoms.
Follow-up visits at 3, 6, and 12 months
Trial Site Locations
Total: 11 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
George Washington University
Washington D.C., District of Columbia, United States, 20052
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, United States, 10010
Actively Recruiting
6
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
7
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
8
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States, 43221
Actively Recruiting
9
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
K
Keith Sigel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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