C-Raven, a Virtual Tobacco Cessation Intervention in the Community
NCT Number: NCT06545669
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Tobacco Dependence
Interventions: BEHAVIORAL: C-Raven Virtual Tobacco Cessation Counseling|DRUG: Nicotine Replacement Product|OTHER: Community Health Worker|OTHER: Lung Cancer Screening
Sponsor: Johns Hopkins University
Collaborators: Maryland Cigarette Restitution Fund|Walgreens
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-06
Locations: Johns Hopkins University School of Medicine, Baltimore, Maryland, 21205, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Readiness to quit smoking as assessed by The Readiness Ruler, The Readiness Ruler is a brief measure of motivation, which prompts patients with a 10-point visual analog scale on which the participant rates readiness, with a score of 0 reflecting "not ready," and a score of 10 reflecting "ready.", 1 month, 3 months, 6 months|Number of participants that start nicotine replacement therapy uptake, Number of participants that start using NRTs at any point during the study period, 1 month, 3 months, 6 months|Number of participants that continue use of nicotine replacement therapy, Number of participants that continue to use NRTs, 1 month, 3 months, 6 months|Number of participants that attempt to quit, Number of participants that attempt to quit, 1 month, 3 months, 6 months|Number of quit attempts, Number of quit attempts each participants makes during the study period, 1 month, 3 months, 6 months|Number of participants that maintain cessation, Number of participants that have maintained cessation for at least one week prior to the assessment, 1 month, 3 months, 6 months|Number of participants that utilize Quit Line services, Number of participants that chose to utilize Quit Line services at any point during the study, 1 month, 3 months, 6 months|Number and frequency of interactions with the community health worker, Engagement with community health worker, 1 month, 3 months, 6 months|Participant satisfaction as assessed by the C-Raven Satisfaction Scale, Overall satisfaction with the intervention. This will be measured with a 21-item questionnaire which uses a 5-item Likert Scale for each question (range 21-105). Higher scores indicate greater satisfaction. Answers of "agree" and "strongly agree" will be evaluated across the intervention components., 1 month, 3 months, 6 months