Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Not Applicable

Not yet recruiting

• Conditions: Tobacco; Tobacco Abstinence; Smoking Cessation; Smoking Cessation; Tobacco Dependence; Human Immunodeficiency Virus (HIV); Cancer Prevention; Tobacco Dependence Caused by Cigarettes

• Registration Number: NCT06883097
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Start: 2025-05
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 474

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically verified 7-day point prevalence abstinence at 24-weeks	24 weeks	Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of \< 5 ppm at Week 24. If the participant does not meet both criteria, 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 5 ppm.

Secondary Outcome Measures

Name	Time	Method
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	Four weeks	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 (not using the substance) at a given point in time	12 weeks	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 (not using the substance) at a given point in time	24 weeks	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 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	4 weeks	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.
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	12 weeks	Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
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	28 weeks	Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
Change in average number of cigarettes smoked per day	24 weeks	Change in self-reported number of cigarettes smoked per day, averaged within groups.
Average number of quit attempts	24 weeks	Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Average duration of app use	Weeks 0-24	Average duration of app use over the 24-week study period.
Average acceptance of physical smoking cravings	24 weeks	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.
Average frequency of app use	Weeks 0-24	Average frequency of app use over the 24-week study period. Measured by average number of app openings.
Average number of app modules completed	Weeks 0-24	Average number of app modules completed over the 24-week study period.