Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | mHealth app consisting of standard, best-practice information and guidance to help people stop smoking. |
|
| Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth Intervention | Device | Mobile health (mHealth) app to motivate and support quitting smoking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention (App) Utilization | Number of unique app user-sessions | 3 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month follow-up |
| App Utilization - Cumulative Days of Use |
| Measure | Description | Time Frame |
|---|---|---|
| Utilization - Personal Experiments | Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10. | 3 month follow-up |
| Quit Guide Participation | Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide). |
Inclusion Criteria Include:
Exclusion Criteria Include:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer McClure, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente WA Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38976321 | Derived | McClure JB, Heffner JL, Krakauer C, Mun S, Catz SL. A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study. JMIR Form Res. 2024 Jul 8;8:e58063. doi: 10.2196/58063. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Experimental |
| 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 | Intervention (App) Utilization | Number of unique app user-sessions | All individuals who installed the app and were not administratively removed (n=19). | Posted | Mean | Standard Deviation | User sessions | 3 months post-enrollment |
|
For each participant, adverse events (AE's) were collected over a 3 month period, starting at baseline and ending at 3-month follow-up. Events were monitored continually during this period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 19) and are subject to missingness for some outcomes. This pilot study was not powered to provide definitive answers about the efficacy of the intervention. A larger trial is needed for this.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer McClure | Kaiser Permanente | 206-287-2737 | jennifer.b.mcclure@kp.org |
Not provided
| 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 | Jan 29, 2024 | Feb 15, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cumulative number of days between the first and last use of the assigned app |
| 3 month follow-up |
| 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. | 3 months post-enrollment |
| 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". | 1 month follow-up |
| 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". | 3 month follow-up |
| Earned Nicotine Replacement Therapy (NRT) | Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy | 3 month follow-up |
| 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. | 3-months post-enrollment |
| 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. | 3 month follow-up |
| Number of Cigarettes Smoked Per Day | Self-reported average number of cigarettes smoked per day at follow-up | 1 month follow-up |
| Number of Cigarettes Smoked Per Day | Self-reported average number of cigarettes smoked per day at follow-up | 3 month follow-up |
| 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. | 1 month follow-up |
| 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. | 3 month follow-up |
| 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. | 1 month follow-up |
| 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. | 3 month follow-up |
| 3 month follow-up |
| Quit Guide Completion | Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed). | 3 month follow-up |
| Cigarette Tracker Use | Use of the cigarette tracker tool (earning the badge for use). | 3 month follow-up |
| Savings Calculator Use | Use of the savings calculator tool (earning the badge for use). | 3 month follow-up |
| Read Peer Testimonials | Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed. | 3 month follow-up |
| Read Peer Advice | Indication that each page of the peer advice and motivational support vignette was opened and viewed. | 3 month follow-up |
| Journal Opened | Indication the journal was opened at least one time. | 3 month follow-up |
| 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 | 3 month follow-up |
| Completing "Just the Facts" Toolbox Component | Completing and earning the badge for the "just the facts" toolbox component; only available to the experimental arm. | 3 month follow-up |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cigarettes per day | Mean | Standard Deviation | cigarettes/day |
|
|
|
|
| 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. | Individuals randomized to either arm who were not administratively removed (n=22). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
| Secondary | App Utilization - Cumulative Days of Use | Cumulative number of days between the first and last use of the assigned app | All individuals who installed the app and were not administratively removed (n=19). | Posted | Mean | Standard Deviation | days | 3 month follow-up |
|
|
|
|
| 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. | Individuals who installed the app and were not administratively removed (n=19). | Posted | Count of Participants | Participants | 3 months post-enrollment |
|
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month follow-up |
|
|
|
|
| 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". | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow-up |
|
|
|
|
| Secondary | Earned Nicotine Replacement Therapy (NRT) | Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy | 19 (7 control and 12 experimental) participants installed the app and were not administratively removed. | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| 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. | All individuals who installed the app and were not administratively removed (n=19). | Posted | Count of Participants | Participants | 3-months post-enrollment |
|
|
|
| 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. | Participants who received enough badges to earn free NRT; no participants in the control arm met these criteria. | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
| Secondary | Number of Cigarettes Smoked Per Day | Self-reported average number of cigarettes smoked per day at follow-up | Participants who installed the app, were not administratively removed, and responded to the question in the 1-month survey. | Posted | Mean | Standard Deviation | cigarettes/day | 1 month follow-up |
|
|
|
|
| Secondary | Number of Cigarettes Smoked Per Day | Self-reported average number of cigarettes smoked per day at follow-up | Participants who installed the app, were not administratively removed, and responded to the question in the 3-month survey. | Posted | Mean | Standard Deviation | cigarettes/day | 3 month follow-up |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 1 month follow-up |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 3 month follow-up |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 1 month follow-up |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 3 month follow-up |
|
|
|
|
| Other Pre-specified | Utilization - Personal Experiments | Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10. | Participants in the experimental arm who installed the app and were not administratively removed (n=12). | Posted | Mean | Standard Deviation | experiments | 3 month follow-up |
|
|
|
| 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). | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
| 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). | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
| Other Pre-specified | Cigarette Tracker Use | Use of the cigarette tracker tool (earning the badge for use). | Participants who installed the app and were not administratively withdrawn. | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| Other Pre-specified | Savings Calculator Use | Use of the savings calculator tool (earning the badge for use). | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| Other Pre-specified | Read Peer Advice | Indication that each page of the peer advice and motivational support vignette was opened and viewed. | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| Other Pre-specified | Journal Opened | Indication the journal was opened at least one time. | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| 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 | 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). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
|
| 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. | Participants in the experimental arm who installed the app and were not administratively removed and whose data we were able to track (n=11). | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided