Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
3 other identifiers
interventional
100
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
January 23, 2026
January 1, 2026
3.2 years
June 29, 2021
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of adherence to Positively Smoke Free - Mobile (PSF-M)
Adherence is defined by meeting at least one of the following: logging into the application at least 10 of 42 days; watching of \>= 4 of 8 video sessions; AND meeting the definition of Engagement with the intervention as defined by at least one of the following: use of the "HELP" button at least once; OR responding to the text messaging "check-in" at least once. Will be summarized as the proportion of participants who meet the criteria as defined above among all the participants who are enrolled in the study. A two-sided 95% confidence interval will also be reported. Proportion of engagement will be calculated similarly. Will also classify levels of adherence with the intervention and categorize these levels as no adherence, low-level adherence, and high-level engagement. The proportion of participants that fall under each category will be calculated.
Up to 42 days
Number of participants who complete the low dose chest CT scan within 60 days of enrollment
Participants will complete a low dose CT scan for screening purposes
Within 60 days of study registration
Secondary Outcomes (5)
Number of positive screening scans
12 months
Total number of participants with confirmed smoking cessation
At 3 months and 6 months
Number of cigarettes smoked per day
At 3 months
Number of participants reporting anxiety related symptoms (concentration problems, memory problems, insomnia and anxiety) on the NCI PROCTCAE
At 3 months
Number of participants using nicotine replacement therapy at 3 months
At 3 months
Study Arms (1)
Prevention (smoking cessation, nicotine replacement, LDCT)
EXPERIMENTALPatients use the smartphone application, Positively Smoke Free - Mobile, for 42 days. Patients also receive nicotine replacement therapy for 12 weeks. Within 60 days of study registration, patients undergo LDCT.
Interventions
Undergo LDCT
Use Positively Smoke Free - Mobile
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
Study Sites (11)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, 10010, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43221, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith M Sigel
AIDS Malignancy Consortium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2021
First Posted
July 2, 2021
Study Start
March 22, 2023
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
January 23, 2026
Record last verified: 2026-01