NCT06697496

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 772 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
DEVICE	QuitBot Smoking Cessation Chatbot Program	Participate in Quitbot chatbot program
DEVICE	QuitBot Smoking Cessation Text Messaging Program	Participate in Quitbot texting program
OTHER	Survey Administration	Ancillary studies
OTHER	Interview	Ancillary studies
PROCEDURE	Carbon Monoxide Measurement	Ancillary studies

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-10-31
• Completion: 2030-10-31
• First posted: 2024-11-20
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study