Abstract / Summary
Background: In the US, maternal tobacco use is more prevalent in pregnant individuals reporting less than a high school education, low income, rural residence, no private insurance coverage, a mental health diagnosis, and/or race/ethnicity as being American Indian/Alaska Native, Black/African American, or White. Prior evaluation of a large state-funded multi-component maternal smoking cessation program in San Bernardino County demonstrated strong short-term abstinence but substantial dropout and relapse, highlighting the need for alternative delivery models. Objective: To address these challenges, the Smoke-Free HOusehold and ParEnt (Smoke-Free HOPE) protocol was developed to deliver tobacco cessation support through community health worker (CHW) visits. This study protocol describes a pilot randomized controlled trial designed to evaluate the feasibility and acceptability of Smoke-Free HOPE, a CHW-delivered tobacco cessation intervention tailored for pregnant individuals. Methods: This protocol uses a sequential mixed-methods design under a Capability, Opportunity, Motivation-Behavior (COM-B) framework. The study includes (a) a stakeholder analysis for intervention design, and (b) a two-arm pilot feasibility randomized controlled trial enrolling 30 pregnant individuals who want to quit habitual use of tobacco products. The stakeholder analysis will be conducted through a Community Advisory Board. Participants will be randomized to one of two CHW-led models that deliver home or telehealth visits: (a) CHW-Brief Advice (CHW-BA) delivers a maternal smoking cessation curriculum (SCRIPT) adapted for CHWs and cessation of all tobacco products, and (b) CHW-Patient Navigation (CHW-PN) delivers patient navigation and ongoing support for enrollment and engagement using a CHW-curated list of community-based cessation programs. Primary outcomes will assess feasibility (recruitment, retention, and engagement) and acceptability (participant satisfaction, perceived support, and motivation to quit), alongside qualitative evaluation of participant, CHW, and provider experiences; workflow integration; and behavioral and contextual barriers and facilitators influencing implementation and engagement. Results: The study was funded by the Tobacco-Related Disease Research Program (TRDRP), administered by the University of California Office of the President. Participant recruitment occurred over an 18-month period between 2024 and 2026 and concluded in May 2026. Follow-up activities are nearing completion, while data management and preliminary analyses are underway. Study findings are expected to be submitted for publication in 2026. Conclusions: This protocol evaluates two CHW-delivered models for maternal tobacco cessation tailored to pregnancy. Intervention components were selected to address individual, social, and structural barriers to maternal tobacco cessation. Findings will inform refinement of intervention components, implementation strategies, and outcome selection for a future definitive trial. Trial registration: ClinicalTrials.gov NCT06438549 Key words: pilot feasibility trial; community health workers; tobacco cessation; pregnancy; prenatal care Protocol version: Version 2.0