Quitting Matters Human Immunodeficiency Virus Hybrid Trial (QMH)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Human Immunodeficiency Virus (HIV); Tobacco; Tobacco Abstinence; Cancer Prevention; Smoking Cessation; Tobacco Dependence; Tobacco Dependence Caused by Cigarettes
• Intervention / Treatment: Behavioral: Learn to Quit-HIV (LTQ-H) App; Behavioral: QuitStart

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 Type: Interventional
• Enrollment (Estimated): 314
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Studies Coordinator; Phone Number: (984) 377-4306; Email: caitlyn.arnold@advocatehealth.org
• Study Contact Backup: Name: Roger Vilardaga Vierra, Ph.D.; Phone Number: 336-716-1495; Email: Roger.Vilardaga@wfusm.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • Recruiting
      • Wake Forest University, Implementation Science
      • Contact: Principal Investigator; Phone Number: 919-439-3498; Email: Roger.Vilardagaviera@advocatehealth.org
      • Contact: Clinical Studies Coordinator; Phone Number: (984)377-4306; Email: caitlyn.arnold@advocatehealth.org
      • Principal Investigator: Roger Vilardaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Learn to Quit - HIV (LTQ-H) App; a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)	Behavioral: Learn to Quit-HIV (LTQ-H) App; 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.; Other Names: a smoking cessation Digital Therapeutic (DTx)
Active Comparator: QuitStart App; an evidence-based DTx designed for the general population	Behavioral: QuitStart; 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.; Other Names: an evidence-based DTx designed for the general population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 6, 12, 18, and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average frequency of app use	Average frequency of app use over the 24-week study period. Measured by average number of app openings.	Weeks 0-24
Average duration of app use	Average duration of app use over the 24-week study period.	Weeks 0-24
Average number of app modules completed	Average number of app modules completed over the 24-week study period.	Weeks 0-24
Change in average number of cigarettes smoked per day	Change in self-reported number of cigarettes smoked per day, averaged within groups.	12 weeks
Change in average number of cigarettes smoked per day	Change in self-reported number of cigarettes smoked per day, averaged within groups.	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.	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.	24 weeks
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.	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.	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.	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.	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.	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.	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.	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.	24 weeks
Change in average number of cigarettes smoked per day	Change in self-reported number of cigarettes smoked per day, averaged within groups.	6 weeks
Change in average number of cigarettes smoked per day	Change in self-reported number of cigarettes smoked per day, averaged within groups.	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.	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.	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.	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.	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.	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.	18 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); University at Buffalo
• Investigators: Principal Investigator: Roger Vilardaga Viera, Ph.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Tobacco; Smoking Cessation; Quit Smoking; Human immunodeficiency virus (HIV); Tobacco Abstinence
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; Slow Virus Diseases; HIV Infections; Behavior; Health Behavior; Acquired Immunodeficiency Syndrome; Tobacco Use Disorder; Smoking Cessation; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: IRB00112958; 7R01CA285331-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No