An interventional study of Computed Tomography and Smoking Cessation Intervention in HIV Infection and Tobacco-Related Carcinoma, sponsored by AIDS Malignancy Consortium. Recruiting at 11 sites in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by AIDS Malignancy Consortium · Not applicable, Interventional, and Prevention
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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:
I. 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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 9 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
positive. Documentation of HIV-1 infection by means of any one of the following:
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Computed Tomography · Behavioral: Smoking Cessation Intervention
Undergo LDCT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Use Positively Smoke Free - Mobile
Also known as: Smoking and Tobacco Use Cessation Interventions
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.
Time frame: 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
Time frame: Within 60 days of study registration
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.
Time frame: 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.
Time frame: At 3 months and 6 months
Number of cigarettes smoked per day
Smoking quantity (daily cigarette consumption)
Time frame: 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
Time frame: 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.
Time frame: At 3 months
Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 45 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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AIDS Malignancy Consortium