C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07220356
Phase
PHASE4
Status
Recruiting
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Conditions

  • Tobacco Dependence

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Nicotine Replacement Product — DRUG
    Participants will be offered up to a 12-week supply of nicotine patches and either nicotine gum or lozenges.
  • 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.
  • Lung Cancer Screening — OTHER
    After participating in shared decision-making, eligible participants will be referred to primary care physician or existing specialist to complete lung cancer screening.

Study Details

In a residency clinic in Baltimore, the investigators propose to conduct a pilot 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 the residency clinic (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. The investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.

Key Dates

Start date
Dec 10, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • 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.

Primary Outcome Measure

Acceptability and Feasibility as assessed by number of participants who complete modules [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21205
Alejandra Ellison-Barnes, MD
[email protected]
410-614-1135
Heidi Hutton, PhD
[email protected]
443-287-2874

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By research site
Johns Hopkins University School of Medicine· Baltimore, MD

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