QuitGuide for American Indians: Aims 2 & 3

Study Overview
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Brief Summary
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Aim 2: To assess the preliminary feasibility and acceptability of a tailored smoking cessation app prototype (here forward called tailored QuitGuide) among American Indian (AI) smokers. Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.

Official Title
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QuitGuide for American Indians: Aims 2 & 3

Conditions
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Tobacco Use, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Tailored QuitGuide app
* Behavioral: Standard QuitGuide app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Indian person based on self-report Age ≥ 18 years Interested in quitting smoking Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product Smartphone ownership with the ability to download applications and sufficient data to complete research procedures Exclusion Criteria: Aim 2 • Does not speak or read English Aim 3 Participation in Aim 2 New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month Does not speak or read English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Aim 2: All participants in this aim will use the tailored QuitGuide app Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aim 2: Tailored App (pilot run of Aim 3)<br>All participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. | Behavioral: Tailored QuitGuide app<br>* This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.<br>|
| Experimental: Aim 3:Tailored App<br>Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. | Behavioral: Tailored QuitGuide app<br>* This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.<br>|
| Placebo Comparator: Aim 3: Standard App<br>Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone. | Behavioral: Standard QuitGuide app<br>* This is an app available to the public.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of app use | The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization. | 2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of app use | The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization. | 1 week post-randomization for aim 3/ Not applicable for aim 2 | 
| Frequency of interactions with various app features (e.g. quit tips, trigger list) over the 5 weeks | The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization. | 2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3 | 
| Study attrition measured as percentage of randomized participants that complete the final phone interview at 5 weeks | Percentage of randomized participants that complete the final phone interview at 5 weeks | 5 weeks post enrollment aim 3 | 
| Frequency of returning saliva sample by 2 weeks post the week 5 interview | Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention) | 5 weeks post enrollment aim 3 | 
| Usability of App Design measured using System Usability scale (SUS) | Scores for each question (1-5) are added together for an overall score and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100 and presented as percentile rankings. Mean and standard deviations or medians and ranges of percentile rankings will be calculated. | 5 weeks post enrollment | 
| Acceptability of overall app | Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'How likely would you be to recommend the app to a friend?' and 'Would you be interested in using the app in the future if needed?' | 5 weeks post enrollment | 
| Fit of app with culture | Mean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'The app fits my American Indian culture such as its history, traditions, and customs' and ' The app makes me feel more connected to my American Indian culture such as its history, traditions, and customs.' | 5 weeks post enrollment |