Pilot Feasibility Study of a Community Health Worker-delivered Tobacco Cessation Intervention During Pregnancy: The Smoke-Free HOPE Randomized Controlled Trial

Introduction: Tobacco use during pregnancy increases risks for adverse birth outcomes. In the US, tobacco use during pregnancy is associated with several poverty-related social determinants of health (fewer years of education, housing and food insecurity, substance abuse) that also contribute to adverse birth outcomes. In the Smoke-free Household and Parent (Smoke-free HOPE) pilot feasibility study, we designed and tested a theory-based intervention (socio-ecological framework) that leverages our group's ten years of experience enrolling and evaluating the largest maternal smoking cessation program in San Bernardino County. The Smoke-free HOPE intervention is delivered by community health workers (CHW) and integrates tobacco cessation support into the other support services that are typically offered during perinatal CHW visits. To our knowledge, this is the first US-based study to test a CHW-delivered prenatal tobacco cessation intervention. Methods: The Smoke-free HOPE intervention is a two-arm RCT that randomizes pregnant adults (n=32) who use tobacco products (combustible, e-cigarettes/vapes) to one of two CHW-delivered interventions: brief behavioral advice or patient navigation to community-based tobacco cessation services (i.e., state quitline). Both intervention arms were delivered during up to eight CHW visits (home, telehealth). Primary feasibility and acceptability outcomes are reported. Results: At baseline, we found that the predominant form of habitual tobacco use was e-cigarettes (53%) and that co-use of cannabis occurred in 69%. Two participants switched from cigarettes/cigars (blunts) to e-cigarettes during the trial. For feasibility, we met our recruitment and retention progression criteria by achieving the following: a county-based enrollment of four consenting participants per month, 87% initiating CHW support (i.e., dropout rate of <13%), and 66% completing all eight CHW visits. For post-intervention acceptability, 91% were very satisfied with the program, and 100% would recommend it to their peers. Post-intervention key informant interviews revealed that participants valued the trust, flexibility, and nonjudgmental support of CHW visits. Seventy-five percent [95% CI = 60% to 90%] set a quit date, and 50% [95% CI = 33% to 67%] achieved 30-day point-prevalence abstinence from nicotine. Conclusions: We have documented the feasibility and acceptability of a CHW-delivered intervention to provide cessation support for all major tobacco products used by pregnant adults in our community. Scaling the intervention to multiple sites will help us measure its efficacy.