TobaccoQMHNCT06883097
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
A study testing Learn to Quit-HIV (LTQ-H) App and QuitStart in people with Tobacco and Tobacco Abstinence, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco, Tobacco Abstinence, Smoking Cessation
- What is being tested?
- Learn to Quit-HIV (LTQ-H) App and QuitStart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported daily cigarette smoking over the past 30 days
- Self-reported HIV status
- Age 18 or older
- Desire to quit smoking
- Willing and medically eligible to use NRT
- Currently receiving HIV care
- Currently owning an Android or iOS smartphone
Who cannot join
- 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
- Not able to fluently speak and write in English
- Hearing, comprehension, visual, speech, or motor limitations that preclude study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University, Implementation Science
Winston-Salem, North Carolina, 27101
Principal Investigator, 919-439-3498, Roger.Vilardagaviera@advocatehealth.org
Clinical Studies Coordinator, (984)377-4306, caitlyn.arnold@advocatehealth.org
About this study
Official title: Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV
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.
Read the detailed description
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.
- Conditions
- Tobacco, Tobacco Abstinence, Smoking Cessation, Smoking Cessation; Tobacco Dependence, Human Immunodeficiency Virus (HIV), Tobacco Dependence Caused by Cigarettes
- Being tested
- Learn to Quit-HIV (LTQ-H) App, QuitStart
- Keywords
- Tobacco, Smoking Cessation, Human immunodeficiency virus (HIV), Tobacco Abstinence, Quit Smoking
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learn to Quit-HIV (LTQ-H) AppBehavioural
Also called a smoking cessation Digital Therapeutic (DTx)
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.
QuitStartBehavioural
Also called an evidence-based DTx designed for the general population
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.
| Study group | Role | What they receive |
|---|---|---|
| Learn to Quit - HIV (LTQ-H) App | Experimental | a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH) Receives: Behavioral: Learn to Quit-HIV (LTQ-H) App |
| QuitStart App | Active comparator | an evidence-based DTx designed for the general population Receives: Behavioral: QuitStart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 6, 12, 18, and 24
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 6 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 12 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 18 weeks
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0-24
Average duration of app use
Average duration of app use over the 24-week study period.
Measured: Weeks 0-24
Average number of app modules completed
Average number of app modules completed over the 24-week study period.
Measured: Weeks 0-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start18 Aug 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TobaccoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roger Vilardaga Viera, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883097
- Sponsor's protocol ID
- IRB00112958
- Other IDs
- 7R01CA285331-02
- Acronym
- QMH
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No