Clinical trial NCT06883097: Quitting Matters Human Immunodeficiency Virus Hybrid Trial
Official title: Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco
Tobacco Abstinence
Smoking Cessation
Smoking Cessation; Tobacco Dependence
Human Immunodeficiency Virus (HIV)
Tobacco Dependence Caused by Cigarettes
Cancer Prevention
Keywords: Tobacco
Smoking Cessation
Human immunodeficiency virus (HIV)
Tobacco Abstinence
Quit Smoking
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: University at Buffalo
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2025-03-19
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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 5 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.

Eligibility criteria: Inclusion Criteria:

1. Self-reported daily cigarette smoking over the past 30 days
2. Self-reported HIV status
3. Age 18 or older
4. Desire to quit smoking
5. Willing and medically eligible to use NRT
6. Currently receiving HIV care
7. Currently owning an Android or iOS smartphone

Exclusion Criteria:

1. Current acute psychotic episode or unsafe to participate in the study
2. Pregnant or intending to become pregnant in the next 6 months
3. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
4. Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician
5. Not able to fluently speak and write in English
6. Hearing, comprehension, visual, speech, or motor limitations that preclude study participation

Primary outcomes:
measure: Biochemically verified 7-day point prevalence abstinence at 24-weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Self-reported 7-day point prevalence abstinence at 4 weeks - the percentage of participants who are abstinent (not using the substance) at a given point in time
timeFrame: Four weeks
measure: Self-reported 7-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent (not using the substance) at a given point in time
timeFrame: 12 weeks
measure: Self-reported 7-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent (not using the substance) at a given point in time
timeFrame: 24 weeks
measure: Self-reported 30-day point prevalence abstinence at 4 weeks - the percentage of participants who are abstinent (not using the substance) at a given point in time
timeFrame: 4 weeks
measure: Self-reported 30-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent (not using the substance) at a given point in time
timeFrame: 12 weeks
measure: Self-reported 30-day point prevalence abstinence at 28 weeks - the percentage of participants who are abstinent (not using the substance) at a given point in time
timeFrame: 28 weeks
measure: Change in average number of cigarettes smoked per day
timeFrame: 4 weeks
measure: Change in average number of cigarettes smoked per day
timeFrame: 12 weeks
measure: Change in average number of cigarettes smoked per day
timeFrame: 24 weeks
measure: Average number of quit attempts
timeFrame: 4 weeks
measure: Average number of quit attempts
timeFrame: 12 weeks
measure: Average number of quit attempts
timeFrame: 24 weeks
measure: Average acceptance of physical smoking cravings
timeFrame: 4 weeks
measure: Average acceptance of physical smoking cravings
timeFrame: 12 weeks
measure: Average acceptance of physical smoking cravings
timeFrame: 24 weeks
measure: Average frequency of app use
timeFrame: Weeks 0-24
measure: Average duration of app use
timeFrame: Weeks 0-24
measure: Average number of app modules completed
timeFrame: Weeks 0-24
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Roger Vilardaga Viera, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: