Smoking Cessation Pilot for People Living With HIV (PLWH)

Study Overview
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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.

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.

Official Title
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A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)

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

Intervention / Treatment
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* Device: Lumme mobile phone application
* Behavioral: Standard of Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: Lumme mobile phone application<br>* Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors<br>Behavioral: Standard of Care<br>* Smoking cessation counseling and nicotine replacement therapy<br>|
| Other: Control<br>The Control group receives standard smoking cessation counseling and nicotine replacement therapy | Behavioral: Standard of Care<br>* Smoking cessation counseling and nicotine replacement therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence | 7-day point prevalence abstinence was calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visit biochemically verified by exhaled Carbon Monoxide (eCO) collected at 12 weeks. Participants with eCO levels <6 parts per million (ppm) at 12 weeks were classified as abstinent while participants with eCO levels ≥6ppm at 12 weeks were classified as not abstinent. | Baseline, 12 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks | 7-day point prevalence abstinence was calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visit. | Baseline, 12 weeks follow up | 
| Change in eCO in Ppm From Baseline to 12-week Follow-up | Exhaled Carbon Monoxide (eCO) was measured via Micro +TM basic Smokerlyzer® in parts per million (ppm) and collected at Baseline and at 12-week Follow-up. Theoretically possible result values range from 0 to 150 ppm with higher values indicating more eCO. Mean change for this study was calculated as Baseline eCO value minus 12-week Follow-up eCO value such that positive mean values indicate a decrease in eCO from Baseline to 12-week Follow-up. | Baseline to 12-week Follow-up | 
| Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score | The CES-D measure contains 20 items asking respondents to rate how often over the past week they experienced depression-associated symptoms. Response options are coded as: 0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time. Scores are calculated by reversing scores for positive statements and adding all responses together. Scores range from 0 to 60, with higher scores indicating greater presence of depressive symptoms. | Baseline, 12-week Follow-up | 
| Self-reported Number of Cigarettes Smoked Daily at Baseline | During baseline visit, participants were asked to report how many cigarettes they smoked daily during the past 30 days. | Baseline | 
| CAGE Substance Abuse Screening Tool Score at Baseline | The CAGE Substance Abuse Screening Tool contains 4 questions with binary answer options: 1 = Yes, 0 = No. Scores are calculated by adding response values. Scores range from 0 to 4 with higher scores indicating alcohol problems. CAGE stands for the 4 question names: Cut down, Annoyed, Guilty, and Eye-opener | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Tobacco, Cigarette, PLWH, HIV, HIV/AIDS, mHealth, Mobile Health, Lumme, Pilot