Smoking, Smoking Cessation
Conditions
Keywords
HIV
Brief summary
This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.
Detailed description
This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a standard care mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.
Interventions
DEVICEmHealth Intervention
Mobile health (mHealth) app to motivate and support quitting smoking.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Include: * 18 years of age or older; * Comfortable speaking and reading in English; * Smoked at least 100 cigarettes in their lifetime; * Smoked, even a puff, in the past 7 days; * Smoked at least 5 cigarettes a day; * Are interested in quitting smoking someday, but not in the next month; * Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly; * Are willing to upgrade their phone operating system, if needed; * Agree to download and try the app; * Do not use Virtual Private Network (VPN) on their smart phone; * Live in the United States and have a valid U.S.-based mailing address and phone number; * Have been diagnosed with HIV
Exclusion criteria
Include: * Refusing to answer all screening questions * History of dementia or psychosis * Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content * Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention (App) Utilization | 3 months post-enrollment | Number of unique app user-sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| App Installation and Use | 3 month follow-up | Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes. |
| App Utilization - Cumulative Days of Use | 3 month follow-up | Cumulative number of days between the first and last use of the assigned app |
| Self-reported 24-hour Quit Attempt | 3 months post-enrollment | At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt. |
| Satisfaction With App Content and Advice | 1 month follow-up | Satisfaction with the overall content and advice of the assigned app, rated on a Likert scale from 1=not at all satisfied to 5=extremely satisfied. |
| Earned Nicotine Replacement Therapy (NRT) | 3 month follow-up | Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy |
| Not Smoking (Even a Puff) in the Last 7 Days | 3-months post-enrollment | 7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking. |
| Proportion Who Request Nicotine Replacement Therapy | 3 month follow-up | Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm. |
| Number of Cigarettes Smoked Per Day | 1 month follow-up | Self-reported average number of cigarettes smoked per day at follow-up |
| Motivation for Quitting Smoking | 1 month follow-up | Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely. |
| Self-efficacy for Quitting Smoking | 1 month follow-up | Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Completing Just the Facts Toolbox Component | 3 month follow-up | Completing and earning the badge for the just the facts toolbox component; only available to the experimental arm. |
| Utilization - Personal Experiments | 3 month follow-up | Number of personal experiment exercises completed in the experimental arm out of a maximum of 10. |
| Quit Guide Participation | 3 month follow-up | Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide). |
| Quit Guide Completion | 3 month follow-up | Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed). |
| Cigarette Tracker Use | 3 month follow-up | Use of the cigarette tracker tool (earning the badge for use). |
| Savings Calculator Use | 3 month follow-up | Use of the savings calculator tool (earning the badge for use). |
| Read Peer Testimonials | 3 month follow-up | Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed. |
| Read Peer Advice | 3 month follow-up | Indication that each page of the peer advice and motivational support vignette was opened and viewed. |
| Journal Opened | 3 month follow-up | Indication the journal was opened at least one time. |
| Use of More Help Feature | 3 month follow-up | Indication the More Help page (with contact information for a tobacco quit-line and more resources for quitting smoking) was viewed at least one time |
Countries
United States
Participant flow
Recruitment details
Study enrollment began 06/02/2022 and study activities completed 05/20/2023. Participants were recruited through: (1) social media advertisements; (2) direct outreach to Kaiser Permanente Washington members living with HIV; (3) ResearchMatch.org; (4) partnership with various HIV/AIDS service organizations; and (5) community health clinics in the Seattle area.
Pre-assignment details
Twenty-two participants were consented and randomized, of whom 19 ultimately installed the study app and were thus eligible for inclusion in the analytic cohort. Because app installation is a metric of feasibility, we report on both on the number who enrolled (N=22) and were used to assess app installations and the number in the final analytic cohort (N=19).
Participants by arm
| Arm | Count |
|---|---|
| Control mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.
mHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking. | 7 |
| Experimental mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.
mHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking. | 12 |
| Total | 19 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 48.9 years STANDARD_DEVIATION 10.7 | 49.6 years STANDARD_DEVIATION 12.5 | 49.3 years STANDARD_DEVIATION 11.6 |
| Cigarettes per day | 10.3 cigarettes/day STANDARD_DEVIATION 3.5 | 11.9 cigarettes/day STANDARD_DEVIATION 5.2 | 11.3 cigarettes/day STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 13 Participants |
| Sex/Gender, Customized Female gender | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Male gender | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 12 |
| other Total, other adverse events | 0 / 7 | 0 / 12 |
| serious Total, serious adverse events | 0 / 7 | 0 / 12 |
Outcome results
Primary
Intervention (App) Utilization
Number of unique app user-sessions
Time frame: 3 months post-enrollment
Population: All individuals who installed the app and were not administratively removed (n=19).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Intervention (App) Utilization | 4.9 User sessions | Standard Deviation 1.3 |
| Experimental | Intervention (App) Utilization | 8.2 User sessions | Standard Deviation 6.9 |
Comparison: A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.p-value: 0.21995% CI: [-2.33, 9.44]Regression, Linear
Secondary
App Installation and Use
Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes.
Time frame: 3 month follow-up
Population: Individuals randomized to either arm who were not administratively removed (n=22).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | App Installation and Use | 7 Participants |
| Experimental | App Installation and Use | 12 Participants |
Secondary
App Utilization - Cumulative Days of Use
Cumulative number of days between the first and last use of the assigned app
Time frame: 3 month follow-up
Population: All individuals who installed the app and were not administratively removed (n=19).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | App Utilization - Cumulative Days of Use | 54.3 days | Standard Deviation 39.8 |
| Experimental | App Utilization - Cumulative Days of Use | 30.4 days | Standard Deviation 20.6 |
p-value: 0.15395% CI: [-53.44, 9.19]Regression, Linear
Secondary
Earned Nicotine Replacement Therapy (NRT)
Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy
Time frame: 3 month follow-up
Population: 19 (7 control and 12 experimental) participants installed the app and were not administratively removed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Earned Nicotine Replacement Therapy (NRT) | 0 Participants |
| Experimental | Earned Nicotine Replacement Therapy (NRT) | 7 Participants |
p-value: 0.00995% CI: [0.16, 0.85]Barnard's exact test
Secondary
Motivation for Quitting Smoking
Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and responded to the question about motivation to quit in the 3-month survey (n=14).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Motivation for Quitting Smoking | 7.8 score on a scale | Standard Deviation 1.9 |
| Experimental | Motivation for Quitting Smoking | 6.8 score on a scale | Standard Deviation 1.8 |
p-value: 0.63295% CI: [-3.03, 1.93]Regression, Linear
Secondary
Motivation for Quitting Smoking
Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.
Time frame: 1 month follow-up
Population: Participants who installed the app, were not administratively removed, and responded to the question about motivation for quitting in the 1-month survey (n=15).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Motivation for Quitting Smoking | 7.5 score on a scale | Standard Deviation 2.5 |
| Experimental | Motivation for Quitting Smoking | 6.8 score on a scale | Standard Deviation 2.7 |
p-value: 0.995% CI: [-2.67, 2.38]Regression, Linear
Secondary
Not Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Time frame: 3-months post-enrollment
Population: All individuals who installed the app and were not administratively removed (n=19).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Not Smoking (Even a Puff) in the Last 7 Days | 0 Participants |
| Experimental | Not Smoking (Even a Puff) in the Last 7 Days | 0 Participants |
Secondary
Number of Cigarettes Smoked Per Day
Self-reported average number of cigarettes smoked per day at follow-up
Time frame: 1 month follow-up
Population: Participants who installed the app, were not administratively removed, and responded to the question in the 1-month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Cigarettes Smoked Per Day | 7.2 cigarettes/day | Standard Deviation 3.4 |
| Experimental | Number of Cigarettes Smoked Per Day | 8.6 cigarettes/day | Standard Deviation 6.7 |
p-value: 0.46995% CI: [-2.66, 5.44]Regression, Linear
Secondary
Number of Cigarettes Smoked Per Day
Self-reported average number of cigarettes smoked per day at follow-up
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and responded to the question in the 3-month survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Cigarettes Smoked Per Day | 7.4 cigarettes/day | Standard Deviation 3.4 |
| Experimental | Number of Cigarettes Smoked Per Day | 7.9 cigarettes/day | Standard Deviation 3.6 |
p-value: 0.61495% CI: [-3.48, 2.16]Regression, Linear
Secondary
Proportion Who Request Nicotine Replacement Therapy
Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.
Time frame: 3 month follow-up
Population: Participants who received enough badges to earn free NRT; no participants in the control arm met these criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Proportion Who Request Nicotine Replacement Therapy | 0 Participants |
| Experimental | Proportion Who Request Nicotine Replacement Therapy | 0 Participants |
Secondary
Satisfaction With App Content and Advice
Satisfaction with the overall content and advice of the assigned app, rated on a Likert scale from 1=not at all satisfied to 5=extremely satisfied.
Time frame: 1 month follow-up
Population: Participants who installed the app, were not administratively removed, responded to the question in the 1-month survey, and earned at least 1 badge by the time of the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Satisfaction With App Content and Advice | 3.0 score on a scale | Standard Deviation 0 |
| Experimental | Satisfaction With App Content and Advice | 3.5 score on a scale | Standard Deviation 0.8 |
p-value: 0.32595% CI: [-0.6, 1.61]Regression, Linear
Secondary
Satisfaction With App Content and Advice
Satisfaction with the overall content and advice of the assigned app, rated on a Likert scale from 1=not at all satisfied to 5=extremely satisfied.
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, responded to the question in the 3-month survey, and earned at least 1 badge by the time of the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Satisfaction With App Content and Advice | 3.2 score on a scale | Standard Deviation 1.3 |
| Experimental | Satisfaction With App Content and Advice | 3.6 score on a scale | Standard Deviation 0.8 |
p-value: 0.74595% CI: [-1.28, 1.72]Regression, Linear
Secondary
Self-efficacy for Quitting Smoking
Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.
Time frame: 1 month follow-up
Population: Participants who installed the app, were not administratively removed, and responded to the question in the 1-month survey about self-efficacy to quit smoking (n=15).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-efficacy for Quitting Smoking | 8.3 score on a scale | Standard Deviation 2.1 |
| Experimental | Self-efficacy for Quitting Smoking | 6.2 score on a scale | Standard Deviation 1.5 |
p-value: 0.22795% CI: [-3.55, -0.94]Regression, Linear
Secondary
Self-efficacy for Quitting Smoking
Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and responded to the question about self-efficacy to quit smoking in the 3-month survey (n=13).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-efficacy for Quitting Smoking | 8.6 score on a scale | Standard Deviation 1.5 |
| Experimental | Self-efficacy for Quitting Smoking | 7.0 score on a scale | Standard Deviation 1.8 |
p-value: 0.27495% CI: [-3.58, 1.15]Regression, Linear
Secondary
Self-reported 24-hour Quit Attempt
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Time frame: 3 months post-enrollment
Population: Individuals who installed the app and were not administratively removed (n=19).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Self-reported 24-hour Quit Attempt | 4 Participants |
| Experimental | Self-reported 24-hour Quit Attempt | 8 Participants |
p-value: 0.72795% CI: [-0.352, 0.558]Barnard's exact test
Other Pre-specified
Cigarette Tracker Use
Use of the cigarette tracker tool (earning the badge for use).
Time frame: 3 month follow-up
Population: Participants who installed the app and were not administratively withdrawn.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Cigarette Tracker Use | 1 Participants |
| Experimental | Cigarette Tracker Use | 3 Participants |
p-value: 0.98195% CI: [-0.39, 0.39]Barnard's exact test
Other Pre-specified
Completing Just the Facts Toolbox Component
Completing and earning the badge for the just the facts toolbox component; only available to the experimental arm.
Time frame: 3 month follow-up
Population: Participants in the experimental arm who installed the app and were not administratively removed and whose data we were able to track (n=11).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Completing Just the Facts Toolbox Component | 3 Participants |
Other Pre-specified
Journal Opened
Indication the journal was opened at least one time.
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Journal Opened | 6 Participants |
| Experimental | Journal Opened | 8 Participants |
p-value: 0.63295% CI: [-0.49, 0.34]Barnard's exact test
Other Pre-specified
Quit Guide Completion
Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed).
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Quit Guide Completion | 0 Participants |
| Experimental | Quit Guide Completion | 0 Participants |
Other Pre-specified
Quit Guide Participation
Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide).
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Quit Guide Participation | 4 Participants |
| Experimental | Quit Guide Participation | 1 Participants |
Other Pre-specified
Read Peer Advice
Indication that each page of the peer advice and motivational support vignette was opened and viewed.
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Read Peer Advice | 1 Participants |
| Experimental | Read Peer Advice | 2 Participants |
p-value: 0.98195% CI: [-0.39, 0.39]Barnard's exact test
Other Pre-specified
Read Peer Testimonials
Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed.
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Read Peer Testimonials | 1 Participants |
| Experimental | Read Peer Testimonials | 1 Participants |
p-value: 0.5695% CI: [-0.47, 0.28]Barnard's exact test
Other Pre-specified
Savings Calculator Use
Use of the savings calculator tool (earning the badge for use).
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Savings Calculator Use | 2 Participants |
| Experimental | Savings Calculator Use | 3 Participants |
p-value: 0.84595% CI: [-0.49, 0.43]Barnard's exact test
Other Pre-specified
Use of More Help Feature
Indication the More Help page (with contact information for a tobacco quit-line and more resources for quitting smoking) was viewed at least one time
Time frame: 3 month follow-up
Population: Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Use of More Help Feature | 4 Participants |
| Experimental | Use of More Help Feature | 6 Participants |
p-value: >0.99995% CI: [-0.48, 0.45]Barnard's exact test
Other Pre-specified
Utilization - Personal Experiments
Number of personal experiment exercises completed in the experimental arm out of a maximum of 10.
Time frame: 3 month follow-up
Population: Participants in the experimental arm who installed the app and were not administratively removed (n=12).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Utilization - Personal Experiments | 3.7 experiments | Standard Deviation 3.3 |