C-Raven, a Virtual Tobacco Cessation Intervention in the Community

NCT06545669 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB00450397
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In low-income housing units in Baltimore, the investigators propose to conduct a pilot two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control. 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.

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (3)

• Acceptability and Feasibility as assessed by number of barriers

  Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).

  1 month, 3 months, 6 months

• Acceptability and Feasibility as assessed by completion of modules

  Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).

  1 month, 3 months, 6 months

• Acceptability and Feasibility as assessed by number of sessions with CHW

  Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).

  1 month, 3 months, 6 months

Secondary Outcomes (9)

• Readiness to quit smoking as assessed by The Readiness Ruler

  1 month, 3 months, 6 months

• Number of participants that start nicotine replacement therapy uptake

  1 month, 3 months, 6 months

• Number of participants that continue use of nicotine replacement therapy

  1 month, 3 months, 6 months

• Number of participants that attempt to quit

  1 month, 3 months, 6 months

• Number of quit attempts

  1 month, 3 months, 6 months

Study Arms (2)

C-Raven + CHW Smoking Cessation Intervention

EXPERIMENTAL

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.

Behavioral: C-Raven Virtual Tobacco Cessation Counseling; Drug: Nicotine Replacement Product; Other: Community Health Worker; Other: Lung Cancer Screening

No Intervention

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.

Interventions

C-Raven Virtual Tobacco Cessation Counseling BEHAVIORAL

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.

C-Raven + CHW Smoking Cessation Intervention

Nicotine Replacement Product DRUG

Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges.

C-Raven + CHW Smoking Cessation Intervention

Community Health Worker OTHER

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.

C-Raven + CHW Smoking Cessation Intervention

Lung Cancer Screening OTHER

After participating in shared decision-making, eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.

C-Raven + CHW Smoking Cessation Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 or older Current tobacco use with \>100 cigarettes smoked in their lifetime
• 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

You may not qualify if:

• Current use of pharmacological treatment for tobacco cessation
• Contraindication to nicotine replacement therapy
• Current engagement in formal smoking cessation program
• Major cognitive or psychiatric impairment
• Severe hearing impairment
• Investigator discretion

Sponsors & Collaborators

• Johns Hopkins University: lead
• Maryland Cigarette Restitution Fund: collaborator
• Walgreens: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Community Health Workers

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Alejandra Ellison-Barnes, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistical analyst will not be made aware of which treatment group received the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants are randomly assigned to intervention or no intervention. Outcomes for those who receive the intervention will be compared to outcomes for those who do not receive the intervention. Those who do not receive the intervention during the initial study period will receive it at the end, to ensure access to treatment for all participants.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: October 30, 2024
• Primary Completion: October 17, 2025
• Study Completion: January 16, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)