Smoke-Free Household and Parent Program (Smoke-Free HOPE): Protocol for a Pilot Feasibility RCT Integrating CHWs into Prenatal Care for Maternal Tobacco Cessation

BackgroundTobacco use remains the most common form of substance use during pregnancy. Persistent disparities in maternal tobacco use exist by ethnicity, rurality, education, insurance and mental health. Between 2012-2019 Loma Linda University Health operated the Comprehensive Tobacco Treatment Program (CTTP), which achieved high short-term quit rates but had high dropout rates This pilot feasibility trial builds on the CTTP strengths while addressing its limitations. Designed through community and stakeholder consultation (2022-2023) through a Community Advisory Board with representation from local public health and maternal health organizations. The overall aim of the Smoke-Free HOusehold and ParEnt (SMOKE-FREE HOPE) pilot trial is to test the feasibility and acceptability of Community Health Worker (CHW)-delivered multi-component interventions that are tailored to pregnant individuals. Secondary aims are to explore preliminary signals of efficacy on tobacco and nicotine use behaviors (including self-reported and biochemically verified abstinence, reduction in use, quit attempts, and relapse prevention), engagement with cessation supports, and perceived social support, to inform outcome selection and power for a future definitive trial. MethodsThis two-arm pilot feasibility randomized controlled trial will enroll approximately 60 pregnant individuals who use tobacco or nicotine products from prenatal clinics and community partner sites in San Bernardino and Riverside Counties, California. Participants will be randomized to (1) CHW-Brief Intervention (CHW-BI) using SCRIPT-based counseling or (2) CHW-Patient Navigation (CHW-PN) using Ask-Advise-Connect to link to state and community cessation resources. Primary outcomes assess feasibility and acceptability, including recruitment, retention, visit adherence, data completeness, and intervention fidelity. Qualitative interviews and focus groups with participants, CHWs, and clinical and community stakeholders will explore acceptability and contextual influences using the Capability, Opportunity, Motivation-Behavior (COM-B) framework. Secondary outcomes include self-reported and biochemically verified abstinence (urine cotinine), tobacco use reduction, quit attempts, relapse prevention, engagement with cessation supports, and perceived social support. A convergent mixed-methods design will integrate quantitative and qualitative data to characterize implementation processes and inform refinement of intervention content, CHW training, and study procedures for future research. DiscussionThis is the first known maternal tobacco cessation intervention in the U.S. to tailor CHW integration specifically for pregnant individuals who want to quit tobacco/vape use. By combining CHW-led home and telehealth visit delivery with adapted evidence-based curricula and resources, the model targets known barriers to engagement and retention among priority populations at highest risk for adverse birth outcomes. Its scope spans the contemporary tobacco exposome, addressing combustible cigarettes alongside e-cigarettes, heated tobacco, and oral nicotine, while embedding behavioral support within a broader social-needs framework (food insecurity, housing instability, polysubstance use). Feasibility and acceptability data from this trial will inform optimization of content and delivery, guide selection of implementation strategies, and power outcomes for subsequent larger randomized trials aimed at improving maternal and infant health equity. Protocol versionVersion 1.0/October 22, 2025