The purpose of this study is to compare the advantages and disadvantages of two approaches for quitting smoking among people living with HIV (PWH). Participants will complete a 24- week (\~6-month) study where the Participants will be assigned to one of two smartphone apps to help with quitting smoking. Regardless of the group participants are assigned to, they will also receive a combination of nicotine replacement therapy (patches and gums) that have been shown to help people quit smoking. The main questions this study aims to answer are:
Participants will complete 6 video call visits over about 6 months. Participants will install their assigned smoking cessation app onto their phone and will be asked to use the app for the duration of the study along with their provided Nicotine Replacement Therapy (NRT) products. During the study visits, participants will meet with study staff to complete questionnaires and interviews. Participants may be asked to provide breath and saliva samples to measure the level of carbon monoxide and nicotine.
Self-reported daily cigarette smoking over the past 30 days
Self-reported HIV status
Age 18 or older
Desire to quit smoking
Current acute psychotic episode or unsafe to participate in the study
Pregnant or intending to become pregnant in the next 6 months
Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
Parallel
Learn to Quit-HIV (LTQ-H) App
BehavioralLTQ-H consists of 319 screens divided into: (a) HIV-tailored smoking cessation ACT skills, (b) education about tobacco dependence and treatment (USCPG), and (c) NRT psychoeducation and adherence. Content is gradually presented across 28 modules (14 education and 14 skills) that can be completed in 14 days.
QuitStart
BehavioralThis DTx, QuitGuide was adapted from the National Cancer Institute Smokefree.gov Initiative's QuitGuide's 5 modules have the following intervention components: (a) psychoeducation about the impact of smoking on health, (b) setting up a quit date and a quit plan, (c) selecting reasons for quitting, (d) tracking triggers and smoking habits, and (e) tips for quitting.
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
Abstinence is determined by a self-report of not smoking any cigarettes for greater than or equal to 7 days prior to Weeks 6, 12, 18, and 24 and biochemically verified by an expired carbon monoxide breath test or a cotinine level saliva test at Weeks 6, 12, 18, and 24. Criteria for the bioverification tests to be considered abstinent includes a reading of \<6 parts per million using an iCOquit Smokerlyzer carbon monoxide breath test OR a cotinine level of 30 or less ng/ml using an iScreen saliva test. If the participant does not meet both criteria of the self report of 7 or more days of abstinence plus a bioverification test below the thresholds listed above, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 6 ppm.
Self-reported 7-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
Self-reported 7-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
Self-reported 7-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
Self-reported 7-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
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Wake Forest University Health Sciences
Lead sponsor
University at Buffalo
Collaborator
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
