Smoking Cessation Pilot for People Living With HIV (PLWH)

Columbia University

Status: Completed

Conditions: Smoking, Cigarette; Smoking Reduction; Smoking, Tobacco; Smoking Behaviors; Hiv; Smoking; HIV/AIDS; Smoking Cessation

Treatments: Device: Lumme mobile phone application; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04808609

AAAS6990

Details and patient eligibility

About

The overall goal of this pilot study is to evaluate the feasibility of the Lumme smartphone app for smoking cessation in people living with HIV (PLWH) and evaluate its effect on smoking cessation. Mobile health (mHealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users. Therefore, a mHealth intervention such as the Lumme App proposed through this study is timely, relevant, scalable and likely to improve health outcomes in PLWH who smoke.

Full description

Of the approximately one million persons living with HIV (PLWH) in the United States (U.S.), it is estimated that between 34-47% smoke cigarettes, around three times the prevalence (12.5%) observed in the general U.S. adult population. Consequently, PLWH experience substantial tobacco-related morbidity and mortality. In PLWH, after achieving and maintaining a suppressed viral load, smoking cessation is the next most important health behavior to maximize both quality of life and life expectancy. Given the high prevalence of cigarette smoking among PLWH and the benefit of smoking cessation, there is an urgent need for swift action to intervene to reduce tobacco use rates. However, evidence to improve tobacco cessation among PLWH is inadequate. Given the need for improving smoking cessation in PLWH, and the great promise of mHealth tools, this research study will assess smoking behaviors in people living with HIV and the subsequent efficacy of mHealth intervention for improving tobacco cessation.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PLWH
• ≥ 18 years old
• own an Android smartphone
• understand and read English
• not pregnant or breastfeeding
• permanent contact information
• smokes greater than or equal to 5 cigarettes per day for the past 30 days
• interested in quitting smoking within 30 days
• blow ≥ 6 carbon monoxide (CO) into a breath analyzer at baseline

Exclusion criteria

• self-report being HIV-negative or unknown status
• pregnant, breastfeeding, or planning to become pregnant during the study period
• planning to move within 3 months of enrollment
• a positive history of a medical condition that precludes use of the nicotine patch
• current use of nicotine replacement therapy or other smoking cessation medications
• current enrollment in another smoking cessation program
• blows ≤ 5 CO into a breath analyzer at baseline.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Intervention

Experimental group

Description:

The Intervention group receives standard smoking cessation counseling and nicotine replacement therapy AND access to the Lumme app that tracks smoking behaviors and provides cessation support.

Treatment:

Behavioral: Standard of Care

Device: Lumme mobile phone application

Control

Other group

Description:

The Control group receives standard smoking cessation counseling and nicotine replacement therapy

Treatment:

Behavioral: Standard of Care