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

• ClinicalTrials.gov Identifier: NCT04949464
• Recruitment Status: Recruiting
• First Posted: July 2, 2021
• Last Update Posted: December 12, 2023
• Sponsor: AIDS Malignancy Consortium
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): AIDS Malignancy Consortium

Tracking Information

• First Submitted Date: June 29, 2021
• First Posted Date: July 2, 2021
• Last Update Posted Date: December 12, 2023
• Actual Study Start Date: March 22, 2023
• Estimated Primary Completion Date: May 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 15, 2022)

• Rate of adherence to Positively Smoke Free - Mobile (PSF-M) [ Time Frame: 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 enrollment [ Time Frame: Within 60 days of study registration ]
  Participants will complete a low dose CT scan for screening purposes

Original Primary Outcome Measures (submitted: June 29, 2021)

• Adherence to Positively Smoke Free - Mobile (PSF-M) [ Time Frame: Up to 42 days ]
  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.
• Adherence to low dose computed tomography (LDCT) [ Time Frame: Within 60 days of study registration ]
  Will be summarized (separately) 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.

Current Secondary Outcome Measures (submitted: December 15, 2022)

• Number of positive screening scans [ Time Frame: 12 months ]
  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.
• Total number of participants with confirmed smoking cessation [ Time Frame: At 3 months and 6 months ]
  As confirmed by exhaled carbon monoxide (CO) testing for assessment of long-term impact of smoking cessation interventions.
• Number of cigarettes smoked per day [ Time Frame: At 3 months ]
  Smoking quantity (daily cigarette consumption)
• Number of participants reporting anxiety related symptoms (concentration problems, memory problems, insomnia and anxiety) on the NCI PROCTCAE [ Time Frame: At 3 months ]
  Acceptability of both PSF-M and LDCT as rated by subject self-report
• Number of participants using nicotine replacement therapy at 3 months [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: June 29, 2021)

• Number of positive screening scans [ Time Frame: Within 12 months of baseline lung cancer screen ]
  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.
• Biochemically confirmed smoking abstinence [ Time Frame: At 6 months ]
  As confirmed by exhaled carbon monoxide (CO) testing for assessment of long-term impact of smoking cessation interventions. Will be estimated separately at 3 and 6 months as: total number of participant with confirmed cessation at 3 months/total number of evaluable participants at 3 months and total number of participant with confirmed cessation at 6 months/total number of evaluable participants at 6 months. 95% confidence intervals will be estimated for each of these proportions.
• Smoking quantity (daily cigarette consumption) [ Time Frame: At 3 months ]
• Smoking quantity (daily cigarette consumption) [ Time Frame: At 6 months ]
• Acceptability of both Positively Smoke Free - Mobile and low dose computed tomography [ Time Frame: At 3 months ]
  As rated by subject self-report (will assess with short questionnaire used in previous studies PSF-M and LDCT among persons living with human immunodeficiency virus at 3-month visit).
• Patient-reported outcomes [ Time Frame: At baseline ]
  Estimating the prevalence of PRO-CTCAE outcomes using the 95% confidence interval. Will also test for association between baseline measures to 3 month and baseline to 6-month measures using McNemar's test.
• Patient-reported outcomes [ Time Frame: At 6 months ]
  Estimating the prevalence of PRO-CTCAE outcomes using the 95% confidence interval. Will also test for association between baseline measures to 3 month and baseline to 6-month measures using McNemar's test.
• Self-reported use of prescribed nicotine replacement [ Time Frame: 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.

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: June 29, 2021)

• Level of adherence with Positively Smoke Free - Mobile and adherence with low dose computed tomography screening [ Time Frame: Up to 12 months ]
  Will conduct bivariate comparisons of the characteristics of subjects associated with higher levels of adherence, testing for significance using the chi-square test. Using patient characteristic data, we will also identify any factors associated with LDCT non-adherence using bivariate comparisons.
• Incidental findings on low dose computed tomography [ Time Frame: Up to 12 months ]
  Will calculate the overall prevalence of incidental LDCT-related endpoints. The prevalence of each incidental LDCT-related endpoint will be estimated as "Total number participants experiencing the endpoint/total number of participants enrolled x 100."

Descriptive Information

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

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• HIV Infection
• Tobacco-Related Carcinoma

Intervention

• Procedure: Computed Tomography
  Undergo LDCT
  Other Names:

  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography
• Behavioral: Smoking Cessation Intervention
  Use Positively Smoke Free - Mobile
  Other Name: Smoking and Tobacco Use Cessation Interventions

Study Arms

Experimental: Prevention (smoking cessation, nicotine replacement, LDCT)

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.

Interventions:

• Procedure: Computed Tomography
• Behavioral: Smoking Cessation Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 29, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2026
• Estimated Primary Completion Date: May 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04949464
• Other Study ID Numbers: AMC-111; NCI-2021-04019 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); AMC-111 ( Other Identifier: AIDS Malignancy Consortium ); AMC-111 ( Other Identifier: CTEP ); UM1CA121947 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: AIDS Malignancy Consortium
• Original Responsible Party: Same as current
• Current Study Sponsor: AIDS Malignancy Consortium
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Keith M Sigel; AIDS Malignancy Consortium

• PRS Account: AIDS Malignancy Consortium
• Verification Date: December 2023