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

NCT06289192 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00396489
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT). The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), 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 and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (2)

• Acceptability and Feasibility as Assessed by the Number of Participants Who Complete Intervention and Surveys

  Acceptability and Feasibility will be assessed by the number of participants who complete intervention and surveys

  3 months

• Acceptability and Feasibility as Assessed by Barriers to Screening

  Acceptability and Feasibility will be assessed by barriers to screening

  Baseline, 1 month, 3 months

Secondary Outcomes (2)

• Number of Participants That Uptake Nicotine Replacement Therapy

  3 months

• Participant Engagement With Community Health Worker (CHW) as Assessed by Number of CHW Interactions

  3 months

Study Arms (1)

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 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.

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

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.

Smoking Cessation Intervention

Nicotine Replacement Product DRUG

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

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.

Smoking Cessation Intervention

Lung Cancer Screening OTHER

Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.

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 6 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

Study Sites (3)

Chase House Apartments

Baltimore, Maryland, 21201, United States

Location

Monument East

Baltimore, Maryland, 21202, United States

Location

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

Results Point of Contact

• Title: Alejandra Ellison-Barnes
• Organization: Johns Hopkins University

aelliso6@jhmi.edu

n/a

Study Officials

• Jeanne Clark, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 1, 2024
• Study Start: April 30, 2024
• Primary Completion: August 23, 2024
• Study Completion: August 27, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)