Learn to Quit-HIV Pilot Study

Duke University

Status: Completed

Conditions: Tobacco Use Disorder; Smoking Cessation; HIV/AIDS

Treatments: Drug: Nicotine patch; Behavioral: Smartphone coaching; Device: Learn to Quit-HIV; Behavioral: QuitGuide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04609514

Pro00104423

Details and patient eligibility

About

The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S. Clinical Practice Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. Both apps will be integrated with NRT and ongoing HIV clinical care.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-positive
• Currently engaged with an HIV care provider
• Self-report smoking 5 cigarettes or more per day during the past 30 days
• Age 18 years or older
• Current interest in quitting smoking
• Currently own a functioning Android or Apple smartphone

Exclusion criteria

• No desire to quit smoking
• Inability to attend study sessions
• Inability to provide informed consent
• Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigators and/or Study Physician
• Presence of contraindications for nicotine patch
• Previous allergic reaction or hypersensitivity to nicotine patch (lifetime)
• Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion, varenicline)
• Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study
• Current untreated and unstable diagnosis of alcohol/substance abuse or dependence (eligible if past abuse/dependence and if receiving treatment and stable for >30 days)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Learn to Quit-HIV

Experimental group

Description:

A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.

Treatment:

Behavioral: Smartphone coaching

Drug: Nicotine patch

Device: Learn to Quit-HIV

QuitGuide

Active Comparator group

Description:

A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.

Treatment:

Behavioral: Smartphone coaching

Drug: Nicotine patch

Behavioral: QuitGuide