NCT07111936

Evaluating the Impact of CONNECT in a Multilingual Population

Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 439 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.

Detailed description

PRIMARY OBJECTIVES: I. Culturally adapt, translate, improve and fine tune the multi-faceted CONNECT program for multilingual smokers II. Evaluate the CONNECT multilingual program for current smokers in multilingual communities. III. Assess the impact of the CONNECT Multilingual program on smoking cessation rates and participant utilization of evidence-based resources to help quit smoking OUTLINE: FOCUS GROUP (N=24): Three focus groups, one each with English, Spanish and Cantonese speaking participants (8 in each group) will be led by investigators. Interviews will be recorded, transcribed and translated. Translation of the Spanish and Cantonese transcripts will be done by University of California, San Francisco (UCSF) translation services. BETA GROUP (N=15): The investigators will conduct a pilot, beta testing of the intervention materials with English, Spanish and Cantonese speaking participants. Additional feedback and input from the participants will be used to fine tune the CONNECT smoking cessation intervention to be implemented in a randomized trial. RANDOMIZED CONTROLLED TRIAL (N=400): Newly enrolled participants will be assigned to 1 of 2 conditions. * Group 1: Participants receive the CONNECT Multilingual intervention. Participants will be followed up at 1-week, 1-, 3-, and 6-months after treatment assignment. At 6-months, participants will be asked to complete and return an at-home saliva kit to verify their smoking status. * Group 2: Participants receive usual care from providers at a regular primary care appointment. Participants will be followed up at 1-week, 1-, 3-, and 6-months after treatment assignment.

Conditions

• Smoking Cessation
• Smoking Cessation Counseling Ability and Practice
• Smoking Cessation Counselling
• Lung Cancer Screening

Interventions

Type	Name	Description
BEHAVIORAL	CONNECT Intervention for multilingual populations	The program includes interactive Video Doctor visits to provide participants with information tailored to their individual responses and outreach via brief telephone calls and text messaging to follow-up and connect smokers with evidence-based resources for smoking cessation.
OTHER	Saliva Sample	Undergo saliva collection
OTHER	Interview	Attend a focus group

Timeline

• Start date: 2026-01-31
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-08-08
• Last updated: 2025-08-27

Locations

1 site across 1 country: United States