Smoking CessationCONNECT-MLNCT07111936
Evaluating the Impact of CONNECT in a Multilingual Population
A study testing CONNECT Intervention for multilingual populations, Saliva Sample and Interview in people with Smoking Cessation and Smoking Cessation Counseling Ability and Practice, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking Cessation Counseling Ability and Practice, Smoking Cessation Counselling
- What is being tested?
- CONNECT Intervention for multilingual populations, Saliva Sample and Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-80 years old.
- Current smokers defined at smoking at least one cigarette in past 7 days AND eligible for lung cancer screening (LCS) based on smoking history (>=20 pack year history)
- California (CA) residents
- Able to understand and comply with study procedures for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Non-smokers.
- Individuals with a diagnosis of lung cancer.
- Individuals receiving hospice care.
- Individuals whose providers do not think that they should participate (e.g., psychiatric illness or significant cognitive impairment that would impede the individuals ability to participate).
- Hearing and/or vision disabilities that would prevent participants from adequately receiving treatment components such as video or telephone counseling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Anita Ponce, MSc, 415-502-1317, Anita.Ponce@ucsf.edu
Judith Walsh, MD, MPH
About this study
Official title: Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Being tested
- CONNECT Intervention for multilingual populations, Saliva Sample, Interview
- Keywords
- Multilingual
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECT Intervention for multilingual populationsBehavioural
Also called CONNECT Multilingual program
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.
Saliva SampleOther
Also called Saliva Sample collection
Undergo saliva collection
InterviewOther
Attend a focus group
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Other | Participants in the focus group will be interviewed by the study staff and discuss barriers and facilitators to smoking cessation to be implemented in the beta and randomized phases of the study. Receives: Other: Interview |
| Beta Group | Active comparator | Participants will be testing the CONNECT multilingual smoking cessation materials and provide feedback to investigators. Participation will be limited to about 1.5 - 2 hours. Receives: Behavioral: CONNECT Intervention for multilingual populations |
| Group 1: CONNECT Multi-lingual intervention | Experimental | Participants receive the CONNECT multilingual smoking cessation intervention finalized in the beta group analysis, that includes multi-lingual interactive video doctor intervention, text messages once weekly for 12 weeks, and several telephone counseling calls. Participants also receive access to a pharmacist to receive counseling about quitting smoking and may prescribe nicotine replacement therapy. Participants will be asked to provide a saliva sample at the end of the study Receives: Behavioral: CONNECT Intervention for multilingual populations; Other: Saliva Sample |
| Group 2: Control Group | Experimental | Participants will receive usual care for smoking cessation at routine medical visit and be asked to complete a total of four brief follow-up phone surveys. Participants will be asked to provide a saliva sample at the end of the study. Receives: Other: Saliva Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants Smoking cessation rates (Randomized groups only)
The rate of smoking cessation will be defined as the percentage of participants who are abstinent from smoking through self-report and biochemical verification using salivary cotinine levels obtained at 6 months after lung cancer screening
Measured: Up to 6 months
Mean number of quit attempts over time (Randomized groups only)
The number of self-reported 7-day quit attempts over time since lung cancer screening (LCS) will be recorded. Mean and standard deviation will be reported.
Measured: Up to 6 months
Percentage of participants who reported use of smoking cessation resources (Randomized groups only)
Self-reported use of evidence-based smoking cessation resources (enabling factors) after the lung cancer screening (for example, pharmacotherapy for smoking cessation, calling the California Smokers Helpline, group or individual counseling from healthcare providers, etc.) will be reported as a percentage of all participants by arm.
Measured: Up to 6 months
Secondary outcomes (2)
Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only)
The participants readiness to quit will be measured using the Stages of Change questionnaire - single item, which asks "Are you seriously thinking of quitting smoking?" Answers range from 'Yes, within the next 30 days', 'Yes, within the next 6 months', and 'No, not thinking of quitting'. Changes in frequency of response over time will be reported.
Measured: Up to 6 months
Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only)
The RMQ is a 11 item self-report, that is used to assess the degree to which measures a person may be ready or motivated to change smoking habits and behaviors. The questionnaire consists of 3 factors: Change smoking behavior (5 items), Motivation to cut down (4 items), and Confidence (2 items). Questions are responded to as Yes/No, or range from "Not at all" to "Very", or ask the duration of time before quitting smoking. The greater the number of positive responses indicates a greater readiness to quit, a greater motivation to quit, and/or a greater confidence to quit smoking.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start7 Aug 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will be enrolled in the focus group. Once completed, new participants will be enrolled in the beta group. After interim analysis has been completed, new participants will be enrolled in the randomized arms.
- Masking
- None (open label)
- Enrolment
- 439 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Judith Walsh, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111936
- Sponsor's protocol ID
- 25635
- Other IDs
- NCI-2025-05153
- Acronym
- CONNECT-ML
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population
- ClinicalTrials.gov ID
- NCT07111936
- Acronym / sponsor ID
- CONNECT-ML / 25635
- Conditions
- Smoking Cessation, Smoking Cessation Counseling Ability and Practice, Smoking Cessation Counselling, Lung Cancer Screening
- Keywords
- Multilingual
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 439 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled in the focus group. Once completed, new participants will be enrolled in the beta group. After interim analysis has been completed, new participants will be enrolled in the randomized arms.
| Arm | Type | Receives |
|---|---|---|
| Focus Group | Other | Other: InterviewParticipants in the focus group will be interviewed by the study staff and discuss barriers and facilitators to smoking cessation to be implemented in the beta and randomized phases of the study. |
| Beta Group | Active comparator | Behavioral: CONNECT Intervention for multilingual populationsParticipants will be testing the CONNECT multilingual smoking cessation materials and provide feedback to investigators. Participation will be limited to about 1.5 - 2 hours. |
| Group 1: CONNECT Multi-lingual intervention | Experimental | Behavioral: CONNECT Intervention for multilingual populations, Other: Saliva SampleParticipants receive the CONNECT multilingual smoking cessation intervention finalized in the beta group analysis, that includes multi-lingual interactive video doctor intervention, text messages once weekly for 12 weeks, and several telephone counseling calls. Participants also receive access to a pharmacist to receive counseling about quitting smoking and may prescribe nicotine replacement therapy. Participants will be asked to provide a saliva sample at the end of the study |
| Group 2: Control Group | Experimental | Other: Saliva SampleParticipants will receive usual care for smoking cessation at routine medical visit and be asked to complete a total of four brief follow-up phone surveys. Participants will be asked to provide a saliva sample at the end of the study. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-80 years old.
- Current smokers defined at smoking at least one cigarette in past 7 days AND eligible for lung cancer screening (LCS) based on smoking history (>=20 pack year history)
- California (CA) residents
- Able to understand and comply with study procedures for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (5 listed)
- Non-smokers.
- Individuals with a diagnosis of lung cancer.
- Individuals receiving hospice care.
- Individuals whose providers do not think that they should participate (e.g., psychiatric illness or significant cognitive impairment that would impede the individuals ability to participate).
- Hearing and/or vision disabilities that would prevent participants from adequately receiving treatment components such as video or telephone counseling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONNECT Intervention for multilingual populationsAlso: CONNECT Multilingual programThe 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. | Behavioural | Beta Group, Group 1: CONNECT Multi-lingual intervention |
| Saliva SampleAlso: Saliva Sample collectionUndergo saliva collection | Other | Group 1: CONNECT Multi-lingual intervention, Group 2: Control Group |
| InterviewAttend a focus group | Other | Focus Group |
Primary outcome
Percentage of participants Smoking cessation rates (Randomized groups only)
Time frame: Up to 6 months
The rate of smoking cessation will be defined as the percentage of participants who are abstinent from smoking through self-report and biochemical verification using salivary cotinine levels obtained at 6 months after lung cancer screening
Mean number of quit attempts over time (Randomized groups only)
Time frame: Up to 6 months
The number of self-reported 7-day quit attempts over time since lung cancer screening (LCS) will be recorded. Mean and standard deviation will be reported.
Percentage of participants who reported use of smoking cessation resources (Randomized groups only)
Time frame: Up to 6 months
Self-reported use of evidence-based smoking cessation resources (enabling factors) after the lung cancer screening (for example, pharmacotherapy for smoking cessation, calling the California Smokers Helpline, group or individual counseling from healthcare providers, etc.) will be reported as a percentage of all participants by arm.
2 secondary outcomes
Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only)
Time frame: Up to 6 months
Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith Walsh, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONNECT Intervention for multilingual populations, Saliva Sample and Interview in people with Smoking Cessation and Smoking Cessation Counseling Ability and Practice, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Ponce, MSc (415-502-1317, Anita.Ponce@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants Smoking cessation rates (Randomized groups only) (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.