HIV InfectionNCT04949464
Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
A study testing Computed Tomography and Smoking Cessation Intervention in people with HIV Infection and Tobacco-Related Carcinoma, run by AIDS Malignancy Consortium at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- HIV Infection, Tobacco-Related Carcinoma
- What is being tested?
- Computed Tomography and Smoking Cessation Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Mar 2023to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43221
Gretchen A McNally, MD, 614-293-3196, gretchen.mcnally@osumc.edu
Gretchan A McNally, MD
- Recruiting
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Edwin Ostrin, MD, 713-792-7734, CR_Study_Registration@mdanderson.org
Edwin Ostrin, MD
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Jayamalee De Silva, MD, 858-822-5377, jadesilva@health.ucsd.edu
Erin Reid, MD
- Recruiting
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, 10010
Kinge-Ann Marcelin, 212-746-5613, kim@med.cornell.edu
Grant Ellsworth, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Keith Sigel, MD, 212-659-8551, keith.sigel@mssm.edu
Keith Sigel, MD
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Julie Barta, MD, 215-955-5161, julie.barta@jefferson.edu
Julie Barta, MD
- Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
Eliza Moore, 206-287-6274, Eliza.moore@vmfh.org
David Aboulafia, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Lee Ratner, MD, PhD, 314-362-8836, lratner@wustl.edu
Lee Ratner, MD, PhD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Alisia Sowden, 813-745-6541, Alisia.Sowden@Moffitt.org
Anna Coghill, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Jill Salvi, 857-399-5039, jsalvi@montefiore.org
Balazs Halmos, MD
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20052
Lakeisha McCormick, 202-994-0872, lmccorm@gwu.edu
Maria Elena Ruiz, MD
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of a smartphone-based human immunodeficiency virus (HIV)-specific behavioral smoking cessation intervention that can be delivered at the time of low dose non contrast enhanced lung computed tomography (LDCT), as measured by use of and engagement with the intervention.
II. Determine the adherence to LDCT in a study setting for persons living with HIV (PLWH) who smoke.
SECONDARY OBJECTIVES:
- Determine the prevalence of positive LDCT screens and related follow-up procedures (which may include any of the following: follow-up computed tomography [CT] scan at an interval less than 12 months from the screening LDCT; (2) positron emission tomography (PET) with or without CT scan; (3) transthoracic needle biopsy; (4) bronchoscopy, with or without biopsy; (5) surgical biopsy and/or resection) in PLWH who smoke.
II. Quantify the proportions of persons who quit smoking at 3 and 6 months after using the HIV-specific smoking cessation intervention and receiving LDCT screening.
III. Obtain preliminary estimate of the proportion of participants who use prescribed nicotine replacement (self-reported) at 3-month visit.
EXPLORATORY OBJECTIVES:
- Identify characteristics associated with PLWH who smoke who are more likely to engage with an HIV-specific smoking cessation intervention.
II. Quantify LDCT screening-related study endpoints (i.e. incident lung cancers, emphysema, and other incidental findings in PLWH who smoke.
III. Compare LDCT screening-relevant patient reported outcomes (anxiety, insomnia, pain) at 3 and 6 months after LDCT to evaluate screening tolerability.
OUTLINE:
Patients 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.
After completion of study intervention, patients are followed up at 3, 6, and 12 months.
- Conditions
- HIV Infection, Tobacco-Related Carcinoma
- Being tested
- Computed Tomography, Smoking Cessation Intervention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo LDCT
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Use Positively Smoke Free - Mobile
| Study group | Role | What they receive |
|---|---|---|
| Prevention (smoking cessation, nicotine replacement, LDCT) | Experimental | Patients 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. Receives: Procedure: Computed Tomography; Behavioral: Smoking Cessation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Within 60 days of study registration
Secondary outcomes (5)
Number of positive screening scans
Defined as Lung Computed Tomography Screening Reporting and Data System (Lung-RADS 3) or higher and follow-up procedures. The estimate of prevalence of "positive LDCT screen" (Lung-RADS > 3) will be computed as "total number of participants who test positive/Total number of participants enrolled × 100". Bivariate association between LDCT screening status and age category, number of smoking pack years will be evaluated separately using either Chi-square test or Fisher's exact test (for sparsely distributed cells). Prevalence of lung cancer will be calculated in a similar manner.
Measured: 12 months
Total number of participants with confirmed smoking cessation
As confirmed by exhaled carbon monoxide (CO) testing for assessment of long-term impact of smoking cessation interventions.
Measured: At 3 months and 6 months
Number of cigarettes smoked per day
Smoking quantity (daily cigarette consumption)
Measured: At 3 months
Number of participants reporting anxiety related symptoms (concentration problems, memory problems, insomnia and anxiety) on the NCI PROCTCAE
Acceptability of both PSF-M and LDCT as rated by subject self-report
Measured: At 3 months
Number of participants using nicotine replacement therapy at 3 months
The proportion of participants who use nicotine replacement at 3 months will be computed as "total number of participants with self-reported nicotine replacement usage/total number of participants enrolled". Bivariate association between nicotine usage status and categorical variables will be tested for statistical significance using the Chi-square or Fisher's exact test. Difference in continuous covariates with regards to nicotine usage status will be tested for statistical significance using Kruskal-Wallis test. In each of the aforementioned analysis that involves estimating proportions, a two-sided 95% confidence interval will also be reported.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start22 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Keith M Sigel, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949464
- Sponsor's protocol ID
- AMC-111
- Other IDs
- NCI-2021-04019, AMC-111, AMC-111, UM1CA121947
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No