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Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Hybrid Trial of a Digital Therapeutic for Smoking Cessation Among Persons Living With HIV

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Learn to Quit-HIV (LTQ-H) App (behavioral)
• QuitStart (behavioral)

Sponsor: Wake Forest University Health Sciences · Participants: 314 · Started: Aug 18, 2025

Contact the study team

• Roger Vilardaga Vierra, Ph.D. · Phone: 336-716-1495
• Clinical Studies Coordinator · Phone: (984) 377-4306

Official record on ClinicalTrials.gov — NCT06883097

Locations in the U.S.

Conditions

• Quitting Smoking
• Quitting Smoking (Tobacco Use Disorder)
• HIV

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.