A Smartphone Application (QuitBot) for the Improvement of Smoking Cessation Among American Indians and Alaska Natives, NAITIVE Trial

OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.

ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.

After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.

• QuitBot Smoking Cessation Chatbot Program (Device), also known as QuitBot chatbot program: Participate in Quitbot chatbot program
• QuitBot Smoking Cessation Text Messaging Program (Device), also known as QuitBot texting program: Participate in Quitbot texting program
• Survey Administration (Other): Ancillary studies
• Interview (Other): Ancillary studies
• Carbon Monoxide Measurement (Procedure), also known as CMONOX: Ancillary studies

Primary outcomes

• 30-day point prevalence abstinence (PPA) [At 12-months post-randomization]: Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) carbon monoxide (CO)-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.

Secondary outcomes

• 30-day PPA [At 3- and 6- months post-randomization]: Also 24-hour and 7-day PPA at the 3-, 6-, and 12- month follow-ups. Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) CO-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.
• Measures of bond between user and conversational chatbot [At 3- and 6-months post-randomization]: Will be measured via four subscales of the 12-item Working Alliance Inventory for Tobacco (WAIT-12), with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators. Number of times participants engaged with the intervention will be adjusted in Poisson regressions that account for the number of prompts a participant received.
• Agreement on goals of treatment [At 3- and 6-months post-randomization]: Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.
• Agreement on tasks of treatment [At 3- and 6-months post-randomization]: Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.
• User's sense that QuitBot understands their needs [At 3- and 6-months post-randomization]: Will be measured via four subscales of the WAIT-12, with technology intervention adaptations similar to those of prior chatbot research. Will calculate the proportion of treatment effect explained by each of the mediators.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
* Age 18 and older
* Smoking combustible cigarettes daily in the past year
* Interest in quitting smoking
* Interest in learning skills to quit smoking
* Willing to be randomly assigned
* Have daily access to their own Android or iPhone smartphone
* Ability to download a smartphone app
* Ability to read English
* Not currently (i.e., within past 30 days) using other smoking cessation interventions
* No prior participation in our studies
* No prior use of SFT
* No household or family member participating
* US residency for the next twelve months
* Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
* Providing email, phone number(s), and mailing address

Exclusion Criteria:

* The reverse of the inclusion criteria
* Pregnant or breastfeeding
* Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability

• Jonathan Bricker, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: U19MD020533