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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | Other | The Control group receives standard smoking cessation counseling and nicotine replacement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumme mobile phone application | Device | Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, RN | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35980739 | Derived | Schnall R, Liu J, Alvarez G, Porras T, Ganzhorn S, Boerner S, Huang MC, Trujillo P, Cioe P. A Smoking Cessation Mobile App for Persons Living With HIV: Preliminary Efficacy and Feasibility Study. JMIR Form Res. 2022 Aug 18;6(8):e28626. doi: 10.2196/28626. |
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All 40 enrolled participants were randomized.
Participants were recruited from an existing database of persons living with HIV who had participated in earlier studies and agreed to be re-contacted for future studies and posting flyers at a local HIV clinic between 9/29/2020 and 4/19/2021. The first participant was enrolled 10/6/2020 and the final participant was enrolled 4/19/2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Lumme mobile phone application: Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors Standard of Care: Smoking cessation counseling and nicotine replacement therapy |
| FG001 | Control | The Control group receives standard smoking cessation counseling and nicotine replacement therapy Standard of Care: Smoking cessation counseling and nicotine replacement therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Lumme mobile phone application: Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors Standard of Care: Smoking cessation counseling and nicotine replacement therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who provided follow up data at 12 weeks were included in the outcome analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 12 weeks follow up |
|
Adverse events were monitored during the entire study period, an average of 3 months from baseline visit to follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Lumme mobile phone application: Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors Standard of Care: Smoking cessation counseling and nicotine replacement therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Schnall, RN, MPH, PhD, Professor of Disease Prevention and Health Promotion (in Nursing) | Columbia University | 212-342-6886 | rb897@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Nov 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D000074264 | Smoking Reduction |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015658 | HIV Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Behavioral | Smoking cessation counseling and nicotine replacement therapy |
|
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 |
| BG001 | Control | The Control group receives standard smoking cessation counseling and nicotine replacement therapy Standard of Care: Smoking cessation counseling and nicotine replacement therapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Exhaled Carbon Monoxide in parts per million | Participants provided a breath sample at baseline to assess exhaled carbon monoxide in parts per million | Mean | Standard Deviation | parts per million |
|
| OG001 | Control | The Control group receives standard smoking cessation counseling and nicotine replacement therapy Standard of Care: Smoking cessation counseling and nicotine replacement therapy |
|
|
|
| Secondary | 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. | All participants who provided follow up data at 12 weeks were included in the outcome analysis | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 12 weeks follow up |
|
|
|
|
| Secondary | 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. | All participants who provided follow up data at 12 weeks were included in the outcome analysis | Posted | Mean | 95% Confidence Interval | parts per million (ppm) | Baseline to 12-week Follow-up |
|
|
|
|
| Secondary | 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. | All participants who provided follow up data at 12 weeks were included in the outcome analysis | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 12-week Follow-up |
|
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | cigarettes smoked per day | Baseline |
|
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control | The Control group receives standard smoking cessation counseling and nicotine replacement therapy Standard of Care: Smoking cessation counseling and nicotine replacement therapy | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000086982 |
| Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| t-test, 1 sided |
| 0.02 |
| Cohen's D |
| 0.41 |
| Standard Error of the Mean |
| 0.17 |
| 2-Sided |
| 95 |
| 0.07 |
| 0.74 |
| Other |
feasibility |