An interventional study of Learn to Quit-HIV (LTQ-H) App and QuitStart in Tobacco, Tobacco Abstinence and Smoking Cessation, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
Tobacco use has alarmingly high rates among people with Human Immunodeficiency Virus (HIV) (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for National Institute of Health. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population.
Exclusion Criteria:
a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)
Behavioral: Learn to Quit-HIV (LTQ-H) App
an evidence-based DTx designed for the general population
Behavioral: QuitStart
LTQ-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.
Also known as: a smoking cessation Digital Therapeutic (DTx)
This 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.
Also known as: an evidence-based DTx designed for the general population
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.
Time frame: Weeks 6, 12, 18, and 24
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.
Time frame: 6 weeks
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.
Time frame: 12 weeks
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.
Time frame: 18 weeks
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.
Time frame: 24 weeks
Self-reported 30-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 30 days but \< 30 days prior to the timepoint.
Time frame: 6 weeks
Self-reported 30-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 30 days prior to the timepoint.
Time frame: 12 weeks
Self-reported 30-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 30 days prior to the timepoint.
Time frame: 18 weeks
Self-reported 30-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 30 days prior to the timepoint.
Time frame: 24 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time frame: 6 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time frame: 12 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time frame: 18 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time frame: 24 weeks
Average number of quit attempts
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
Time frame: 6 weeks
Average number of quit attempts
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
Time frame: 12 weeks
Average number of quit attempts
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
Time frame: 18 weeks
Average number of quit attempts
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking cigarettes at all for 24 hours or more.
Time frame: 24 weeks
Average acceptance of physical smoking cravings
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time frame: 6 weeks
Average acceptance of physical smoking cravings
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time frame: 12 weeks
Average acceptance of physical smoking cravings
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time frame: 18 weeks
Average acceptance of physical smoking cravings
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time frame: 24 weeks
Average frequency of app use
Average frequency of app use over the 24-week study period. Measured by average number of app openings.
Time frame: Weeks 0-24
Average duration of app use
Average duration of app use over the 24-week study period.
Time frame: Weeks 0-24
Average number of app modules completed
Average number of app modules completed over the 24-week study period.
Time frame: Weeks 0-24
Plan to share: No
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Wake Forest University Health Sciences