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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Washington, D.c.
George Washington University
RECRUITING
Washington D.c.
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New York
Mount Sinai Hospital
RECRUITING
New York
Weill Cornell Medicine - Cornell Clinical Trials Unit
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
The Ohio State University James Cancer Hospital
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Texas
University of Texas M.D. Anderson Cancer Center
RECRUITING
Houston
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Contact Information
Primary
Keith Sigel
Keith.Sigel@MSSM.edu
(212) 659-8551
Time Frame
Start Date: 2023-03-22
Estimated Completion Date: 2026-12-26
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: AIDS Malignancy Consortium
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov