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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV
- ClinicalTrials.gov ID
- NCT06883097
- Acronym / sponsor ID
- QMH / IRB00112958
- Conditions
- Tobacco, Tobacco Abstinence, Smoking Cessation, Smoking Cessation; Tobacco Dependence, Human Immunodeficiency Virus (HIV), Tobacco Dependence Caused by Cigarettes
- Keywords
- Tobacco, Smoking Cessation, Human immunodeficiency virus (HIV), Tobacco Abstinence, Quit Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University at Buffalo, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learn to Quit - HIV (LTQ-H) App | Experimental | Behavioral: Learn to Quit-HIV (LTQ-H) Appa smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH) |
| QuitStart App | Active comparator | Behavioral: QuitStartan evidence-based DTx designed for the general population |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learn to Quit-HIV (LTQ-H) AppAlso: 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. | Behavioural | Learn to Quit - HIV (LTQ-H) App |
| QuitStartAlso: an evidence-based DTx designed for the general populationThis 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. | Behavioural | QuitStart App |
Primary outcome
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks
Time frame: Weeks 6, 12, 18, and 24
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.
23 secondary outcomes
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
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
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
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
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
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
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
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
Time frame: 24 weeks
Change in average number of cigarettes smoked per day
Time frame: 6 weeks
Change in average number of cigarettes smoked per day
Time frame: 12 weeks
Change in average number of cigarettes smoked per day
Time frame: 18 weeks
Change in average number of cigarettes smoked per day
Time frame: 24 weeks
Average number of quit attempts
Time frame: 6 weeks
Average number of quit attempts
Time frame: 12 weeks
Average number of quit attempts
Time frame: 18 weeks
Average number of quit attempts
Time frame: 24 weeks
Average acceptance of physical smoking cravings
Time frame: 6 weeks
Average acceptance of physical smoking cravings
Time frame: 12 weeks
Average acceptance of physical smoking cravings
Time frame: 18 weeks
Average acceptance of physical smoking cravings
Time frame: 24 weeks
Average frequency of app use
Time frame: Weeks 0-24
Average duration of app use
Time frame: Weeks 0-24
Average number of app modules completed
Time frame: Weeks 0-24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tobacco
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Recruiting
Communicating About Nicotine Reduction in Cigarettes
Tobacco Products, Smoking Behavior
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roger Vilardaga Viera, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roger Vilardaga Vierra, Ph.D. (336-716-1495, Roger.Vilardaga@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks (time frame: Weeks 6, 12, 18, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.