Quitting Matters Human Immunodeficiency Virus Hybrid Trial

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.

NCT Number	NCT06883097
Lead Sponsor	Wake Forest University Health Sciences Collaborators: University at Buffalo, National Institutes of Health (NIH), National Cancer Institute (NCI)
Conditions	Tobacco, Tobacco Abstinence, Smoking Cessation, Smoking Cessation; Tobacco Dependence, Human Immunodeficiency Virus (HIV), Tobacco Dependence Caused by Cigarettes, Cancer Prevention
Enrollment	314 participants
Start Date	2025-08-18
Primary Completion	2028-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-17