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

Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)

This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.

Study Overview

• Status: Not yet recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Device: QuitBot Smoking Cessation Chatbot Program; Procedure: Carbon Monoxide Measurement; Device: QuitBot Smoking Cessation Text Messaging Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 772
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Bricker, PhD; Phone Number: 206-667-5074; Email: jbricker@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Jonathan Bricker, PhD; Phone Number: 206-667-5074; Email: jbricker@fredhutch.org
      • Principal Investigator: Jonathan Bricker, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (QuitBot chatbot); Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Device: QuitBot Smoking Cessation Chatbot Program; Participate in Quitbot chatbot program; Other Names: QuitBot chatbot program; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: CMONOX
Active Comparator: Arm II (QuitBot texting); Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study.	Other: Survey Administration; Ancillary studies; Procedure: Carbon Monoxide Measurement; Ancillary studies; Other Names: CMONOX; Device: QuitBot Smoking Cessation Text Messaging Program; Participate in Quitbot texting program; Other Names: QuitBot texting program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day point prevalence abstinence (PPA)	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.	At 12-months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day PPA	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.	At 3- and 6- months post-randomization
Measures of bond between user and conversational chatbot	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.	At 3- and 6-months post-randomization
Agreement on goals of treatment	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.	At 3- and 6-months post-randomization
Agreement on tasks of treatment	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.	At 3- and 6-months post-randomization
User's sense that QuitBot understands their needs	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.	At 3- and 6-months post-randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Jonathan Bricker, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Inorganic Chemicals; Oxides; Oxygen Compounds; Gases; Carbon Compounds, Inorganic; Carbon Monoxide; Interviews as Topic
• Other Study ID Numbers: RG1124884; NCI-2024-08892 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U19MD020533 (U.S. NIH Grant/Contract); FHIRB0020651 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial results data will be published on ClinicalTrials.gov. The de-identified scientific data will be made available as public use data to the research community in openICPSR. No PII or PHI data will be shared or available for secondary use.
• IPD Sharing Time Frame: The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
• IPD Sharing Access Criteria: Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes