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

Smoking Cessation Cancer Prevention Human Immunodeficiency Virus (HIV)Tobacco Tobacco Abstinence Smoking Cessation; Tobacco Dependence Tobacco Dependence Caused by Cigarettes

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

Inclusion Criteria7

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

Exclusion Criteria6

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

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.