Clinical trial NCT04949464: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infection
Tobacco-Related Carcinoma
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of adherence to Positively Smoke Free - Mobile (PSF-M)
timeFrame: Up to 42 days
measure: Number of participants who complete the low dose chest CT scan within 60 days of enrollment
timeFrame: Within 60 days of study registration
Secondary outcomes:
measure: Number of positive screening scans
timeFrame: 12 months
measure: Total number of participants with confirmed smoking cessation
timeFrame: At 3 months and 6 months
measure: Number of cigarettes smoked per day
timeFrame: At 3 months
measure: Number of participants reporting anxiety related symptoms (concentration problems, memory problems, insomnia and anxiety) on the NCI PROCTCAE
timeFrame: At 3 months
measure: Number of participants using nicotine replacement therapy at 3 months
timeFrame: At 3 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: District of columbia
country: United States
facility: George Washington University
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine - Cornell Clinical Trials Unit
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University James Cancer Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: AIDS Malignancy Consortium
name: Keith M Sigel
role: PRINCIPAL_INVESTIGATOR
References: