C-Raven, a Virtual Tobacco Cessation Intervention in the Community
NCT ID: NCT06545669
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2024-10-30
2025-12-30
Brief Summary
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With a sample of participants from public housing units (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. At the 3-month time point, the investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.
Detailed Description
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Participants (N=30) will be recruited through flyers posted in and around the housing units and distributed to tenants by housing unit staff. Flyers will describe the study and contain a study phone number to call. Information may also be distributed by study staff during non-study-related health and wellness activities conducted at the sites. At initial contact, a study staff member will discuss the study purpose and determine eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions via phone, potential participants will be offered the option of reviewing the study information and consent form over a Zoom video conference. Regardless of whether the participants choose to review this information in advance, all potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit, which will be conducted on-site at the participants housing community.
Randomization: Following consent, participants will be randomized to the intervention group or a control group. The control group will not receive any intervention during the first 6 months of the study, but at the end of 6 months will receive the full computer intervention and abbreviated CHW support to ensure access to treatment for all participants.
Baseline Assessment: This will occur on the same day as the in-person portion of the consent process. Initial evaluation will comprise a number of questionnaires/assessments, including demographics, a clinical history, a tobacco use history, and a number of tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment, participants will receive computer-delivered counseling via a study-provided iPad delivered in a private room. The CDI consists of 1) a menu-driven, web-based intervention that is delivered by a virtual counselor. The intervention takes 20 minutes to complete. At the conclusion of session 1, the participant will be offered nicotine patches provided by the study (1 month supply, remainder given at follow-up visits). The initial dosing of the nicotine patches will be determined based on cigarettes consumed per day (\>10: 21mg patch, 5-10: 14mg patch, \<5: 7mg patch). If there is any question regarding eligibility or appropriate dosing, the CHW will consult with a study physician. With the CHW, the participant will learn correct application, and will monitor the participants nicotine replacement therapy (NRT) experience in discussion with the CHW.
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT, bupropion, varenicline). This intervention also takes about 20 minutes to complete. At the conclusion of session 2, the participant will be offered nicotine gum or lozenges provided by the study (1 month supply, remainder given at follow-up visits). This session also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to ensure correct use.
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions 1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2) Follow up with patients remotely via phone or video conference whenever possible, up to twice weekly for 12 weeks (4 weeks for control group receiving delayed intervention), to discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review a video and decision-making guide for lung cancer screening and provide linkage to lung cancer screening if the participant is eligible and interested, including linkage to insurance enrollment assistance, if needed; 4) For individuals requiring follow up for positive findings on lung CT, work with participants to navigate the process; 5) Link interested participants to the QuitLine; 6) At the end of the study, link to medical providers for additional tobacco cessation therapy if participant interested (e.g., varenicline, bupropion).
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the participants primary care physician (PCP) or existing specialist for further discussion and ordering. The CTs are optional and will not be provided as part of the research study. The CHW will assist with linking patients without a PCP or existing specialist with resources to establish care. For participants who choose to proceed with screening, the investigators will request the results of the CT scan to track completion and general result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term Follow-Up/Abnormal Needing Immediate Follow-Up).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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C-Raven + CHW Smoking Cessation Intervention
Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months.
C-Raven Virtual Tobacco Cessation Counseling
A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.
Nicotine Replacement Product
Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges.
Community Health Worker
A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.
Lung Cancer Screening
After participating in shared decision-making, eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.
No Intervention
Participants will not receive any intervention during the first 6 months of the study. The participants will receive the study intervention at the end of 6 months, to ensure access to treatment for all participants.
No interventions assigned to this group
Interventions
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C-Raven Virtual Tobacco Cessation Counseling
A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.
Nicotine Replacement Product
Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges.
Community Health Worker
A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.
Lung Cancer Screening
After participating in shared decision-making, eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.
Eligibility Criteria
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Inclusion Criteria
* English speaking (intervention currently in English only and housing units are in largely English-speaking neighborhoods)
* Considering smoking cessation
* Planning to remain in current housing unit for 9 months
Exclusion Criteria
* Contraindication to nicotine replacement therapy
* Current engagement in formal smoking cessation program
* Major cognitive or psychiatric impairment
* Severe hearing impairment
* Investigator discretion
50 Years
ALL
No
Sponsors
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Maryland Cigarette Restitution Fund
OTHER_GOV
Walgreens
INDUSTRY
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Alejandra Ellison-Barnes, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
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Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Alejandra Ellison-Barnes, MD
Role: primary
Heidi Hutton
Role: backup
Other Identifiers
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IRB00450397
Identifier Type: -
Identifier Source: org_study_id