Quitting Matters Human Immunodeficiency Virus Hybrid Trial

NCT06883097 | Recruiting DMC

• 2 other identifiers: IRB001129587R01CA285331-02
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  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

  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

  6 weeks

Study Arms (2)

Learn to Quit - HIV (LTQ-H) App

EXPERIMENTAL

a smoking cessation Digital Therapeutic (DTx) for people with HIV (PWH)

Behavioral: Learn to Quit-HIV (LTQ-H) App

QuitStart App

ACTIVE COMPARATOR

an evidence-based DTx designed for the general population

Behavioral: QuitStart

Interventions

Learn to Quit-HIV (LTQ-H) App BEHAVIORAL

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.

Also known as: a smoking cessation Digital Therapeutic (DTx)

Learn to Quit - HIV (LTQ-H) App

QuitStart BEHAVIORAL

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.

Also known as: an evidence-based DTx designed for the general population

QuitStart App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University, Implementation Science

Winston-Salem, North Carolina, 27101, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Acquired Immunodeficiency Syndrome

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Roger Vilardaga Viera, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger Vilardaga Vierra, Ph.D.

CONTACT

336-716-1495; Roger.Vilardaga@wfusm.edu

Clinical Studies Coordinator

CONTACT

(984) 377-4306; caitlyn.arnold@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)