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

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

Interventions

DRUG

Nicotine Replacement Product

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

BEHAVIORAL

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Maryland Cigarette Restitution Fund

  collaborator OTHER_GOV

• Walgreens

  collaborator INDUSTRY

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Alejandra Ellison-Barnes, MD · Johns Hopkins School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-30

Primary Completion

2025-10-17

Completion

2026-01-16

FDA Drug

Yes

Countries

• United States

Study Locations