Trial Outcomes & Findings for Smoking Cessation Pilot for People Living With HIV (PLWH) (NCT NCT04808609)
NCT ID: NCT04808609
Last Updated: 2023-02-23
Results Overview
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.
COMPLETED
NA
40 participants
Baseline, 12 weeks follow up
2023-02-23
Participant Flow
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.
All 40 enrolled participants were randomized.
Participant milestones
| Measure |
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
|
Control
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
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
|
Control
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Administrative Withdrawal
|
0
|
1
|
Baseline Characteristics
Smoking Cessation Pilot for People Living With HIV (PLWH)
Baseline characteristics by cohort
| Measure |
Intervention
n=20 Participants
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
|
Control
n=20 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Exhaled Carbon Monoxide in parts per million
|
14.5 parts per million
STANDARD_DEVIATION 6.5 • n=5 Participants
|
13.1 parts per million
STANDARD_DEVIATION 6.3 • n=7 Participants
|
13.8 parts per million
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks follow upPopulation: All participants who provided follow up data at 12 weeks were included in the outcome analysis
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.
Outcome measures
| Measure |
Control
n=17 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Intervention
n=20 Participants
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
|
|---|---|---|
|
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
|
11.8 percentage of participants
Interval 1.5 to 36.4
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks follow upPopulation: All participants who provided follow up data at 12 weeks were included in the outcome analysis
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.
Outcome measures
| Measure |
Control
n=17 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Intervention
n=20 Participants
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
|
|---|---|---|
|
Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
30.0 percentage of participants
Interval 11.9 to 54.3
|
SECONDARY outcome
Timeframe: Baseline to 12-week Follow-upPopulation: All participants who provided follow up data at 12 weeks were included in the outcome analysis
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.
Outcome measures
| Measure |
Control
n=17 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Intervention
n=20 Participants
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
|
|---|---|---|
|
Change in eCO in Ppm From Baseline to 12-week Follow-up
|
2.12 parts per million (ppm)
Interval -0.9 to 5.14
|
3.35 parts per million (ppm)
Interval -0.22 to 6.92
|
SECONDARY outcome
Timeframe: Baseline, 12-week Follow-upPopulation: All participants who provided follow up data at 12 weeks were included in the outcome analysis
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.
Outcome measures
| Measure |
Control
n=17 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Intervention
n=20 Participants
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
|
|---|---|---|
|
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
|
14.8 score on a scale
Interval 10.8 to 18.7
|
16.6 score on a scale
Interval 10.8 to 22.3
|
SECONDARY outcome
Timeframe: BaselineDuring baseline visit, participants were asked to report how many cigarettes they smoked daily during the past 30 days.
Outcome measures
| Measure |
Control
n=20 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Intervention
n=20 Participants
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
|
|---|---|---|
|
Self-reported Number of Cigarettes Smoked Daily at Baseline
|
11.0 cigarettes smoked per day
Interval 9.3 to 12.7
|
11.9 cigarettes smoked per day
Interval 9.5 to 14.3
|
SECONDARY outcome
Timeframe: BaselineThe 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
Outcome measures
| Measure |
Control
n=20 Participants
The Control group receives standard smoking cessation counseling and nicotine replacement therapy
Standard of Care: Smoking cessation counseling and nicotine replacement therapy
|
Intervention
n=20 Participants
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
|
|---|---|---|
|
CAGE Substance Abuse Screening Tool Score at Baseline
|
0.9 score on a scale
Interval 0.3 to 1.5
|
0.9 score on a scale
Interval 0.2 to 1.6
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca Schnall, RN, MPH, PhD, Professor of Disease Prevention and Health Promotion (in Nursing)
Columbia University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place