Quitting Matters Human Immunodeficiency Virus Hybrid Trial

Official title

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

Overview

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.

Detailed 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.

Interventions

• Behavioral Learn 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.
• Behavioral QuitStart
  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.

Primary outcome measures

• Biochemically verified 7-day point prevalence abstinence at 6, 12, 18, and 24-weeks [Time frame: Weeks 6, 12, 18, and 24]

Secondary outcome measures (12)

• Self-reported 7-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 6 weeks]
• Self-reported 7-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 12 weeks]
• Self-reported 7-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 18 weeks]
• Self-reported 7-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 24 weeks]
• Self-reported 30-day point prevalence abstinence at 6 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 6 weeks]
• Self-reported 30-day point prevalence abstinence at 12 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 12 weeks]
• Self-reported 30-day point prevalence abstinence at 18 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 18 weeks]
• Self-reported 30-day point prevalence abstinence at 24 weeks - the percentage of participants who are abstinent from cigarettes at a given point in time [Time frame: 24 weeks]
• Change in average number of cigarettes smoked per day [Time frame: 6 weeks]
• Change in average number of cigarettes smoked per day [Time frame: 12 weeks]
• Change in average number of cigarettes smoked per day [Time frame: 18 weeks]
• Change in average number of cigarettes smoked per day [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Wake Forest University, Implementation Science — Winston-Salem

Identifiers

NCT: NCT06883097 · IRB00112958 · 7R01CA285331-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗