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Official title Impact of Behavior Modification Interventions and Lung Cancer Screening on Smoking Cessation in People Living With HIV: A Feasibility Study
ClinicalTrials.gov ID: NCT04949464
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- 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...
- HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \> 1000 RNA copies/mL;
You likely can't join if
- 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)...
- History of lung cancer
- Pregnant women are excluded from this study because computed tomography introduces radiation exposure and may have teratogenic effects
See the full eligibility 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...
- 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...
- 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...
- 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 people had eligible phones in prior trials although researchers will include specific study screening questions assessing for...
- Sufficient literacy; \>= 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-R) literacy scale
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- St Louis, Missouri, United States
- New York, New York, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Washington D.C., District of Columbia, United States; Tampa, Florida, United States; St Louis, Missouri, United States; New York, New York, United States; The Bronx, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.