RecruitingNot ApplicableNCT06883097

Quitting Matters Human Immunodeficiency Virus Hybrid Trial

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


Sponsor

Wake Forest University Health Sciences

Enrollment

314 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a hybrid program (combining in-person and digital support) to help people living with HIV who smoke cigarettes quit smoking. Participants will receive nicotine replacement therapy and behavioral support. **You may be eligible if...** - You are 18 or older - You are living with HIV and currently receiving HIV care - You have been smoking daily in the past 30 days and want to quit - You are medically eligible to use nicotine replacement therapy (like patches or gum) - You own an Android or iOS smartphone **You may NOT be eligible if...** - You are currently having a psychotic episode or it is unsafe for you to participate - You are pregnant or plan to become pregnant in the next 6 months - You are already in a smoking cessation program - You are not able to speak and write English fluently - You have significant hearing, vision, speech, or motor limitations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLearn 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.

BEHAVIORALQuitStart

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.


Locations(1)

Wake Forest University, Implementation Science

Winston-Salem, North Carolina, United States

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NCT06883097


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