Hiv, HIV/AIDS, Smoking, Smoking Behaviors, Smoking Cessation, Smoking, Cigarette, Smoking Reduction, Smoking, Tobacco
Conditions
Keywords
Smoking, Smoking Cessation, Smoking Behaviors, Smoking Reduction, Tobacco, Cigarette, PLWH, HIV, HIV/AIDS, mHealth, Mobile Health, Lumme, Pilot
Brief summary
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
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.
Interventions
DEVICELumme mobile phone application
Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors
BEHAVIORALStandard of Care
Smoking cessation counseling and nicotine replacement therapy
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence | Baseline, 12 weeks follow up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks | Baseline, 12 weeks follow up | 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. |
| Change in eCO in Ppm From Baseline to 12-week Follow-up | 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. |
| Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score | Baseline, 12-week Follow-up | 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. |
| Self-reported Number of Cigarettes Smoked Daily at Baseline | Baseline | During baseline visit, participants were asked to report how many cigarettes they smoked daily during the past 30 days. |
| CAGE Substance Abuse Screening Tool Score at Baseline | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All 40 enrolled participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Control The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Withdrawal | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 10.2 | 54.0 years STANDARD_DEVIATION 8.5 | 53.7 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 18 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Exhaled Carbon Monoxide in parts per million | 14.5 parts per million STANDARD_DEVIATION 6.5 | 13.1 parts per million STANDARD_DEVIATION 6.3 | 13.8 parts per million STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 18 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Baseline, 12 weeks follow up
Population: All participants who provided follow up data at 12 weeks were included in the outcome analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence | 15.0 percentage of participants |
| Control | Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence | 11.8 percentage of participants |
p-value: 0.7795% CI: [0.24, 6.76]Fisher Exact
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
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | CAGE Substance Abuse Screening Tool Score at Baseline | 0.9 score on a scale |
| Control | CAGE Substance Abuse Screening Tool Score at Baseline | 0.9 score on a scale |
p-value: 0.9995% CI: [-0.61, 0.62]t-test, 2 sided
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.
Time frame: Baseline, 12-week Follow-up
Population: All participants who provided follow up data at 12 weeks were included in the outcome analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score | 16.6 score on a scale |
| Control | Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score | 14.8 score on a scale |
p-value: 0.6195% CI: [-0.46, 0.78]t-test, 2 sided
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.
Time frame: Baseline to 12-week Follow-up
Population: All participants who provided follow up data at 12 weeks were included in the outcome analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change in eCO in Ppm From Baseline to 12-week Follow-up | 3.35 parts per million (ppm) |
| Control | Change in eCO in Ppm From Baseline to 12-week Follow-up | 2.12 parts per million (ppm) |
p-value: 0.5995% CI: [-0.44, 0.86]t-test, 2 sided
Comparison: Results from Paired T-Test assessing the with-subject time effect on exhaled CO in ppm from baseline to 12 weeksp-value: 0.0295% CI: [0.07, 0.74]t-test, 1 sided
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.
Time frame: Baseline, 12 weeks follow up
Population: All participants who provided follow up data at 12 weeks were included in the outcome analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks | 30.0 percentage of participants |
| Control | Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks | 23.5 percentage of participants |
p-value: 0.6695% CI: [0.43, 3.78]Chi-squared
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Self-reported Number of Cigarettes Smoked Daily at Baseline | 11.9 cigarettes smoked per day |
| Control | Self-reported Number of Cigarettes Smoked Daily at Baseline | 11.0 cigarettes smoked per day |
p-value: 0.5595% CI: [-0.42, 0.8]t-test, 2 sided