Smoking Cessation Pilot for People Living With HIV (PLWH)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-07-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Cessation Smoking Smoking Behaviors Smoking Reduction Smoking, Tobacco Smoking, Cigarette Hiv HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Lumme mobile phone application

Intervention Type DEVICE

Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors

Standard of Care

Intervention Type BEHAVIORAL

Smoking cessation counseling and nicotine replacement therapy

Control

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

Group Type OTHER

Standard of Care

Intervention Type BEHAVIORAL

Smoking cessation counseling and nicotine replacement therapy

Interventions

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Lumme mobile phone application

Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors

Intervention Type DEVICE

Standard of Care

Smoking cessation counseling and nicotine replacement therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No