Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05722132
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 2,826
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 4.1
• Patients Per Site Per Month: 693.7

Study Details

Study Description

Brief Summary

Latino Kick Buts (LKB) is a smoking cessation treatment program available to Strong Memorial Hospital patients who smoke. LKB encompasses two integrated components: (1) a 12-week text messaging counseling program with interactive capabilities and (2) pharmacotherapy support (provision of nicotine replacement therapy at no cost). LKB utilization among Latinos who smoke remains minimal. This study aims to identify the types of text messages more effective in enrolling Latinos who smoke, identified in the electronic medical record, into LKB.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: One cycle; Behavioral: 4 cycles; Behavioral: 5 Dollar Incentive; Behavioral: Raffle Incentive	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2826 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Latinos Kick Buts: Mobile Engagement and Cessation Support for Latinos Who Smoke
• Actual Study Start Date: Dec 27, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: One cycle-no monetary incentive	Behavioral: One cycle; Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
Active Comparator: One cycle-fixed amount of incentive	Behavioral: One cycle; Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.; Behavioral: 5 Dollar Incentive; Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program. The introductory message will mention that participants will receive $5 if they enroll in the program or that they should look out for messages with a "$" sign at the beginning that will provide an incentive if they respond.
Active Comparator: One cycle-raffle as incentive	Behavioral: One cycle; Message Design Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.; Behavioral: Raffle Incentive; The incentive message (indicated with a leading "$" sign) will invite participants to respond, and participants that do so will be included in a random drawing depending on the condition. The incentive message for the opportunity to win will contain a link to a website that provides full details of the timing of the drawing, the chances of winning, and when notification of winners will be made.
Active Comparator: 4 cycles- no monetary incentive	Behavioral: 4 cycles; Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.
Active Comparator: 4 cycles- fixed amount of incentive	Behavioral: 4 cycles; Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.; Behavioral: 5 Dollar Incentive; Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program. The introductory message will mention that participants will receive $5 if they enroll in the program or that they should look out for messages with a "$" sign at the beginning that will provide an incentive if they respond.
Active Comparator: 4 cycles- raffle as incentive	Behavioral: 4 cycles; Participants will receive 3 messages per cycle that contain information on how to enroll in a cessation program.; Behavioral: Raffle Incentive; The incentive message (indicated with a leading "$" sign) will invite participants to respond, and participants that do so will be included in a random drawing depending on the condition. The incentive message for the opportunity to win will contain a link to a website that provides full details of the timing of the drawing, the chances of winning, and when notification of winners will be made.

Outcome Measures

Primary Outcome Measures

1. Percentage of participant who enroll in cessation program [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult Latinos who smoke and have received medical care at Strong Memorial Hospital/SHARP healthcare within the last year.

• having smoking status recorded in the EMR

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paula Cupertino, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT05722132
• Other Study ID Numbers: STUDY00007635; R42MD010318
• First Posted: Feb 10, 2023
• Last Update Posted: Feb 10, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 10, 2023