Quitting Matters Human Immunodeficiency Virus Hybrid Trial (QMH)

Wake Forest University (WFU)

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06883097

7R01CA285331-02 (U.S. NIH Grant/Contract)

IRB00112958

Details and patient eligibility

About

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.

Full description

Tobacco use has alarmingly high rates among people with Human Immunodeficiency Virus (HIV) (PWH), 43% compared with 15% in the general population. Due to the development of highly effective treatments for HIV and the resulting increased longevity among PWH, this population now loses more life years to smoking than to HIV infection itself. Novel and effective models to deliver wider reaching smoking cessation interventions for PWH are highly needed and indicated as a priority for National Institute of Health. Digital therapeutics (DTx) may be a novel, scalable, and highly available approach for engaging and treating smoking in this population. However, although DTx for smoking cessation have been shown effective in the general population, no large trial to date has examined the effectiveness of a tailored DTx for smoking cessation in PWH, and no implementation science work has examined barriers and facilitators of implementation of DTx for smoking cessation in this population.

Enrollment: 314 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 2 patient groups

Learn to Quit - HIV (LTQ-H) App

Experimental group

Description:

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

Treatment:

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

QuitStart App

Active Comparator group

Description:

an evidence-based DTx designed for the general population

Treatment:

Behavioral: QuitStart