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Feasibility Study: Smoking Cessation and Lung Cancer Screening for People with HIV

This study is looking at how well a smartphone app, "Positively Smoke Free - Mobile," helps people living with HIV quit smoking, especially when combined with lung cancer screening. Researchers want to see if people use the app as intended and complete a low-dose CT scan (a special X-ray for the lungs). The study also aims to see how many participants successfully quit smoking after 3 and 6 months. You may be able to join if you are 45 to 80 years old, have HIV, and are willing to sign a consent form. The study is currently unclear about its recruitment status and plans to enroll 100 participants.

Study design
This is an interventional study, meaning participants will receive specific interventions. It plans to enroll 100 participants.
What's involved
Participants will use the "Positively Smoke Free - Mobile" app and undergo a low-dose chest CT scan within 60 days of enrollment. Adherence to the app will be measured for up to 42 days.
Compensation
Not stated in the trial record.
Follow-up
The study will measure smoking cessation at 3 and 6 months after using the intervention and receiving screening.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04949464

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

Recruiting
NAAges 45–80InterventionalPrevention
AIDS Malignancy Consortium
~100 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Computed TomographySmoking Cessation Intervention

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of adherence to Positively Smoke Free - Mobile (PSF-M)
Measured over Up to 42 days
+1 more outcome measured

Conditions

HIV Infection
Tobacco-Related Carcinoma

Explore related trials

HIV InfectionLung Carcinoma

Where it's being run

11 sites across 9 states
New York3
California1
District of Columbia1
Florida1
Missouri1
Ohio1
Pennsylvania1
Texas1

Study leadership

  • Keith M Sigel · PRINCIPAL_INVESTIGATOR · AIDS Malignancy Consortium

Who to contact

Keith Sigel
[email protected]
(212) 659-8551
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Rate of adherence to Positively Smoke Free - Mobile (PSF-M)Up to 42 days

    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.

  • Number of participants who complete the low dose chest CT scan within 60 days of enrollmentWithin 60 days of study registration

    Participants will complete a low dose CT scan for screening purposes