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

Smoke-Free Household and Parent Program (Smoke-Free HOPE): Protocol for a Pilot Feasibility RCT Integrating CHWs into Prenatal Care for Maternal Tobacco Cessation | medRxiv /* */ /* */ <!-- <!-- /*! * yepnope1.5.4 * (c) WTFPL, GPLv2 */ (function(a,b,c){function d(a){return"[object Function]"==o.call(a)}function e(a){return"string"==typeof a}function f(){}function g(a){return!a||"loaded"==a||"complete"==a||"uninitialized"==a}function h(){var a=p.shift();q=1,a?a.t?m(function(){("c"==a.t?B.injectCss:B.injectJs)(a.s,0,a.a,a.x,a.e,1)},0):(a(),h()):q=0}function i(a,c,d,e,f,i,j){function k(b){if(!o&&g(l.readyState)&&(u.r=o=1,!q&&h(),l.onload=l.onreadystatechange=null,b)){"img"!=a&&m(function(){t.removeChild(l)},50);for(var d in y[c])y[c].hasOwnProperty(d)&&y[c][d].onload()}}var j=j||B.errorTimeout,l=b.createElement(a),o=0,r=0,u={t:d,s:c,e:f,a:i,x:j};1===y[c]&&(r=1,y[c]=[]),"object"==a?l.data=c:(l.src=c,l.type=a),l.width=l.height="0",l.onerror=l.onload=l.onreadystatechange=function(){k.call(this,r)},p.splice(e,0,u),"img"!=a&&(r||2===y[c]?(t.insertBefore(l,s?null:n),m(k,j)):y[c].push(l))}function j(a,b,c,d,f){return q=0,b=b||"j",e(a)?i("c"==b?v:u,a,b,this.i++,c,d,f):(p.splice(this.i++,0,a),1==p.length&&h()),this}function k(){var a=B;return a.loader={load:j,i:0},a}var l=b.documentElement,m=a.setTimeout,n=b.getElementsByTagName("script")[0],o={}.toString,p=[],q=0,r="MozAppearance"in l.style,s=r&&!!b.createRange().compareNode,t=s?l:n.parentNode,l=a.opera&&"[object Opera]"==o.call(a.opera),l=!!b.attachEvent&&!l,u=r?"object":l?"script":"img",v=l?"script":u,w=Array.isArray||function(a){return"[object Array]"==o.call(a)},x=[],y={},z={timeout:function(a,b){return b.length&&(a.timeout=b[0]),a}},A,B;B=function(a){function b(a){var a=a.split("!"),b=x.length,c=a.pop(),d=a.length,c={url:c,origUrl:c,prefixes:a},e,f,g;for(f=0;f<d;f++)g=a[f].split("="),(e=z[g.shift()])&&(c=e(c,g));for(f=0;f<b;f++)c=x[f](c);return c}function g(a,e,f,g,h){var i=b(a),j=i.autoCallback;i.url.split(".").pop().split("?").shift(),i.bypass||(e&&(e=d(e)?e:e[a]||e[g]||e[a.split("/").pop().split("?")[0]]),i.instead?i.instead(a,e,f,g,h):(y[i.url]?i.noexec=!0:y[i.url]=1,f.load(i.url,i.forceCSS||!i.forceJS&&"css"==i.url.split(".").pop().split("?").shift()?"c":c,i.noexec,i.attrs,i.timeout),(d(e)||d(j))&&f.load(function(){k(),e&&e(i.origUrl,h,g),j&&j(i.origUrl,h,g),y[i.url]=2})))}function h(a,b){function c(a,c){if(a){if(e(a))c||(j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}),g(a,j,b,0,h);else if(Object(a)===a)for(n in m=function(){var b=0,c;for(c in a)a.hasOwnProperty(c)&&b++;return b}(),a)a.hasOwnProperty(n)&&(!c&&!--m&&(d(j)?j=function(){var a=[].slice.call(arguments);k.apply(this,a),l()}:j[n]=function(a){return function(){var b=[].slice.call(arguments);a&&a.apply(this,b),l()}}(k[n])),g(a[n],j,b,n,h))}else!c&&l()}var h=!!a.test,i=a.load||a.both,j=a.callback||f,k=j,l=a.complete||f,m,n;c(h?a.yep:a.nope,!!i),i&&c(i)}var i,j,l=this.yepnope.loader;if(e(a))g(a,0,l,0);else if(w(a))for(i=0;i (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0];var j=d.createElement(s);var dl=l!='dataLayer'?'&l='+l:'';j.src='//www.googletagmanager.com/gtm.js?id='+i+dl;j.type='text/javascript';j.async=true;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-P4HH5NV'); Skip to main content Home About Submit ALERTS / RSS Search for this keyword Advanced Search Smoke-Free Household and Parent Program (Smoke-Free HOPE): Protocol for a Pilot Feasibility RCT Integrating CHWs into Prenatal Care for Maternal Tobacco Cessation View ORCID Profile Anne Berit Petersen , Berenice Rosas , Juan Carlos Belliard , View ORCID Profile Janice Tsoh , View ORCID Profile Bryan Oshiro , View ORCID Profile Ruofan Yao , View ORCID Profile Pramil N. Singh doi: https://doi.org/10.1101/2025.10.26.25338756 Anne Berit Petersen 1 Loma Linda University School of Nursing , Loma Linda, CA 92350 USA 2 Transdisciplinary Tobacco Research Program, Loma Linda University Cancer Center , Loma Linda, CA 92350 USA 3 Loma Linda University School of Public Health , Loma Linda, 92350 CA USA PhD, MPH, RN, CNS Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Anne Berit Petersen For correspondence: abpetersen{at}llu.edu Berenice Rosas 2 Transdisciplinary Tobacco Research Program, Loma Linda University Cancer Center , Loma Linda, CA 92350 USA BS Find this author on Google Scholar Find this author on PubMed Search for this author on this site Juan Carlos Belliard 3 Loma Linda University School of Public Health , Loma Linda, 92350 CA USA PhD, MPH Find this author on Google Scholar Find this author on PubMed Search for this author on this site Janice Tsoh 4 University of California San Francisco , San Francisco, CA 94143 USA PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Janice Tsoh Bryan Oshiro 5 Loma Linda University School of Medicine , Loma Linda, CA 92350 USA 6 Riverside University Health System , Moreno Valley, CA 92555 USA MD, MPH Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Bryan Oshiro Ruofan Yao 5 Loma Linda University School of Medicine , Loma Linda, CA 92350 USA 7 Department of OB/GYN - Maternal Fetal Medicine, Loma Linda University Children’s Hospital , Loma Linda, CA 92354 MD, MPH Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Ruofan Yao Pramil N. Singh 2 Transdisciplinary Tobacco Research Program, Loma Linda University Cancer Center , Loma Linda, CA 92350 USA 5 Loma Linda University School of Medicine , Loma Linda, CA 92350 USA DrPH Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Pramil N. Singh Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract Background Tobacco 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 HO usehold and P ar E nt ( 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. Methods This 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. Discussion This 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 version Version 1.0/October 22, 2025 1 Introduction 1.1 Background The habitual use of tobacco products remains the most prevalent form of substance use during pregnancy ( 1 ). The 2014 U.S. Surgeon General’s Report concluded that habitual use of tobacco products harms both maternal and fetal health, and contributes to adverse birth outcomes such as preterm delivery, low birthweight, and infant mortality ( 2 ). In 2021, an analysis of the Pregnancy Risk Assessment Monitoring System data from 36,493 US women, showed that tobacco use during pregnancy trended higher by rurality, race/ethnicity, ≤12 years of education, Medicaid enrollment, and report of recent depression ( 3 , 4 ). In California, San Bernardino County has long reported one of the highest infant mortality rates in the state, particularly in rural areas of the county and among non-Hispanic Black infants ( 5 , 6 ). During 2012 to 2019, our group at Loma Linda University Health (LLUH) ran the state-funded ( First5CA.gov ) Comprehensive Tobacco Treatment Program (CTTP) that served San Bernardino County. CTTP was the largest prenatal smoking cessation program in the county, was implemented in a classroom setting by health educators, and consisted of a multicomponent behavioral intervention using components of known efficacy (motivational interviewing, feedback, weekly biomarker testing, and incentives) ( 7 ). As part of our 2022 program evaluation of CTTP ( 7 ), we conducted a cohort study of program participants (n=1402) that indicated that despite achieving a high rate of biochemically verified (40.1 %) during the 8 week program, CTTP still reported a high dropout rate, particularly during the third trimester. Another noteworthy program weakness was that program participants from racial/ethnic groups with the highest national rates of tobacco use during pregnancy (American Indian/Alaskan Native, Black/African American, White) also had the highest rate of relapse during CTTP ( 8 ). Lastly, CTTP follow-up pre-dated the major increase in the availability of e-cigarettes/vape products and thus can provide insight into how these products affect tobacco cessation program outcomes ( 8 ). In this report, we provide the protocol for the Smoke-Free HO usehold and P ar E nt ( SMOKE-FREE HOPE ) pilot feasibility trial. The SMOKE-FREE HOPE is designed to build on the strengths (i.e. multicomponent intervention using components of known efficacy) and address weaknesses (i.e. high dropout rate, no e-cigarette cessation component) we identified during the seven years of implementing CTTP. The SMOKE-FREE HOPE protocol is also designed to include the extensive consultation and stakeholder analysis of 2022-2023 Community Advisory Board meetings that included San Bernardino Department of Public Health Community and Family Health services, Black Infant Health of San Bernardino, First5 of San Bernardino, Maternal Health Network of San Bernardino, and Sankofa Birth Collective. CAB members contributed to identifying community priorities, refining intervention components, and shaping implementation and evaluation strategies to ensure alignment with local maternal and child health needs. To address much of what we have learned over a decade of maternal tobacco cessation program implementation in Southern California, SMOKE-FREE HOPE adds a Community Health Worker (CHW) component to the behavioral intervention. In the US, CHWs have been effectively employed to deliver behavioral smoking cessation intervention across diverse adult populations ( 9 - 14 ). Notably, the SMOKE-FREE HOPE model is the first intervention we are aware of that tailors the integration of CHWs to provide tobacco cessation for pregnant individuals through the incorporation, for example, of SCRIPT® (Smoking Cessation and Reduction in Pregnancy Treatment) curriculum adapted for delivery during CHW-led telehealth and home visits ( 15 , 16 ). Overall, the SMOKE-FREE HOPE model is tailored to pregnant individuals in order to address three interrelated needs of pregnant individuals seeking tobacco cessation. First, SMOKE-FREE HOPE addresses low retention rates by moving from a classroom or clinical setting to telehealth and home-visits with CHWs. Second, the emergence of a complex tobacco exposome that includes non-combustible products (e-cigarette and vaping products, IQOS, oral nicotine pouches) needs consideration. The SMOKE-FREE HOPE model tailors the intervention to account for the scenarios where some patients may use non-combustible for cessation, some may be dual users, and others may want to achieve complete nicotine cessation ( 17 - 19 ). Third, our model accounts for the evidence indicating that tobacco use during pregnancy rarely occurs in isolation. It frequently intersects with other social and health-related challenges, such as food insecurity, housing instability, and use of other substances (i.e. cannabis, opioids) ( 20 , 21 ). In this context, the CHW-led intervention allows us to add a brief advice tobacco and nicotine cessation intervention to the overall dashboard of CHW/perinatal support services that occur in Federally Qualified Health Centers (FQHC) settings ( 5 , 22 , 23 ). 1.1 Objectives and Aims 1.1.1 Overall aim The overall aim of the SMOKE-FREE HOPE trial is to test the feasibility and acceptability of CHW-delivered, multi-component interventions that are tailored to pregnant individuals. 1.1.2 Specific Aims Feasibility. Examine the feasibility of CHW-delivered behavioral intervention models (CHW delivered brief advice, CHW-delivered patient navigation) that are tailored to pregnant individuals in a two-arm randomized control trial. Acceptability. Examine the acceptability of CHW-delivered behavioral intervention models (CHW delivered brief advice, CHW-delivered patient navigation) that are tailored to pregnant individuals in a two-arm randomized control trial. 1.1.3 Secondary Exploratory Aim Explore preliminary signals of intervention efficacy on tobacco and nicotine use behaviors and related psychosocial outcomes among pregnant and postpartum participants. These measures will provide insight into potential clinical and behavioral effects and inform outcome selection for a future fully powered randomized controlled trial. 2 Methods 2.1 Trial Design and Setting The protocol for the pilot RCT is registered at ClinicalTrials.gov ( NCT06438549 ). Reporting has been guided by the SPIRIT checklist and the CONSORT extension for pilot and feasibility trials; items were applied as appropriate to an early-phase pilot. Table 1 displays the SPIRIT diagram summarizing the schedule of enrolment, intervention delivery, and outcome assessments for both the pilot RCT and the process evaluation ( 24 - 26 ). View this table: View inline View popup Table 1. SMOKE-FREE HOPE Participant timeline: Schedule of enrollment, interventions, and assessments. 2.1.1 Overview of Study Design SMOKE-FREE HOPE study is a pilot randomized controlled trial (RCT) designed to evaluate the feasibility and acceptability of two community health worker (CHW)-led intervention models, CHW-Brief Intervention (CHW-BI) and CHW-Patient Navigation (CHW-PN), for tobacco and nicotine cessation among pregnant individuals. Participants will be recruited from the Inland Empire (Riverside and San Bernardino Counties, pop approx. 4M) through multiple strategies, including screening electronic medical records and new prenatal care patients at the two largest care providers in the region (Loma Linda University Health (LLUH) and Riverside University Health System (RUHS)), and through a referral network of Inland Empire Obstetrics/Gynecology (OB/GYN) provider clinics and community-based organizations which builds on the network developed during the CTTP ( 7 ). 2.1.2 Study Setting The study setting is defined by a multi-site recruitment from the Inland Empire region (Riverside and San Bernardino Counties; 11% of the CA population)( 27 ) that includes: 1) Maternal-Fetal Medicine at Loma Linda University Health (MFM-LLUH) that handles referrals from Federal Qualified Health Centers (FQHC) of San Bernardino County and has a multidisciplinary team (OB/GYN physicians, nurse clinicians, LVNs, health educator, and sonographers) for implementation/referral to social determinants of health (SDOH) programs, 2) Riverside University Health System (RUHS) that comprises 13 FQHCs of Riverside County and has similar multidisciplinary teams for high risk pregnancies, and 3) a referral network of prenatal care provider clinics and community-based organizations in the Inland Empire with data coordination by the study team supported by the LLUH Center for Data Science. Recruitment will occur on-site and through outreach to a network of community-based organizations (CBOs) across both counties that collaborate with these health systems. 2.1.3 Participant Eligibility The trial aims to recruit adult participants who are currently pregnant, aged 18 years or older, current user of tobacco or nicotine products or recently quit, and receive prenatal care at LLUH, RUHS or with another community-based OB provider in San Bernardino County. Current use is defined as any of the following: (a) combustible cigarette users with a lifetime history of at least 100 cigarettes and who report smoking more than three cigarettes, cigars, or blunts per day within the past seven days; (b) users of e-cigarettes/vapes containing a tobacco component on at least 25 of the past 30 days; (c) users of heated tobacco products (e.g., IQOS™) on at least 25 of the past 30 days; (d) users of smokeless tobacco or oral nicotine pouches on at least 25 of the past 30 days; or (e) poly-tobacco users who meet the 25-of-30-day threshold with any combination of the above products. Eligible participants must be willing to quit and set a quit date within two weeks or have already quit during the current pregnancy (including self-directed nicotine replacement therapy) but express concern about relapse. Individuals will be excluded if 1) they have severe mental health conditions that would impede informed consent or participation in the community health worker (CHW) intervention, 2) if they have participated in another cessation program within the prior 30 days, and 3) they are unwilling to take part in audio-recorded key-informant interviews or focus groups. These criteria are intended to recruit a population representative of the clinical settings while ensuring appropriateness for the intervention and the planned outcome assessments. 2.1.4 Recruitment Recruitment for the SMOKE-FREE HOPE trial will be conducted through a multi-pronged strategy designed to maximize outreach. Recruitment will occur through self-directed referral, provider referral pathways, electronic medical records, and community partnerships. 2.1.4.1 Self-directed referrals These referrals primarily occur through our placement of recruitment materials (e.g., electronic and printed flyers with QR code linked to the study website) and links to the study website at health care sites, maternal health network sites, and media announcements. 2.1.4.2 Provider referral pathways These on-site referrals occur during routine prenatal care. At the larger health care systems (LLUH, RUHS) this is done by pregnant patients reporting, as part of standard of care, tobacco product use to the clinic’s pre-natal care intake team (i.e. social worker, nurse) and receiving a team referral to SMOKE-FREE HOPE . 2.1.4.3 Electronic Medical Records EMR informatics will be used to identify currently pregnant individuals who reported tobacco or e-cigarette use within the past three months. Patients will receive tailored outreach messages about the program with the option to express “I’m interested”. 2.1.4.4 Community Partnerships The referral network is expanded through partnerships with community-based organizations that allow outreach at maternal health and perinatal events, presentations to local organizations and coalitions, and collaboration with regional health plans to facilitate referrals. All strategies will be refined in an iterative process in collaboration with the Community Advisory Board. 2.1.5 Enrollment procedures SMOKE-FREE HOPE will use a two-step process. During a brief telephone/video pre-screen, the Project Coordinator (PC) will obtain verbal permission to assess preliminary eligibility. Before any study activities, eligible participants will provide written informed consent with HIPAA authorization and acknowledgment of the California Experimental Research Subject’s Bill of Rights. Consent will typically be completed via secure video (or in person), with key study elements summarized (e.g., biospecimen collection, surveys, CHW visits, optional household involvement, confidentiality, and the right to withdraw). Executed copies will be provided to participants, and the consent process will be documented per institutional and regulatory requirements. Enrollment will be finalized when the site Medical Director (or clinical designee) reviews the record and signs off that all eligibility criteria are met. 2.1.6 Randomization and Blinding Enrolled participants will be assigned a trial registration number by the PC that will be used for randomization. Randomization by the PC will be done by generating a permuted block randomization schedule using SAS (Proc PLAN, Cary, NC). This will be provided by the Trial Office at LLUH. Due to the behavioral nature of the intervention, participants and CHWs cannot be blinded to group assignment; however, outcome assessors and data analysts will remain blinded to allocation to minimize bias. 2.1.7 Incentives Participants will receive prorated Amazon e-gift cards tied to specific study activities (e.g., baseline and follow-up surveys, biospecimen collection, and completed CHW visits). See Table 1 . Additional compensation is offered for participation in qualitative activities (interviews/focus groups), and a final incentive is provided at 6-month study follow-up. Incentives are issued at the time each activity is completed, are not contingent on outcomes, and are calibrated to align with typical U.S. behavioral trials in pregnant populations and ethical guidance to avoid undue influence. 2.2 Community Advisory Board (CAB) Engagement Development and refinement of the SMOKE-FREE HOPE interventions were guided by input from a Community Advisory Board (CAB) convened throughout 2022-2023. The CAB is comprised of representatives from the San Bernardino County Department of Public Health Community and Family Health Services, Black Infant Health of San Bernardino, First 5 San Bernardino, the Maternal Health Network of San Bernardino, and the Sankofa Birth Collective. The CAB provided iterative feedback on study design, recruitment strategies, and intervention materials to enhance cultural and contextual relevance. CAB discussions also informed the adaptation of the e-cigarette cessation component, refinement of CHW training materials, and the selection of outcome measures related to acceptability and feasibility. Ongoing engagement with CAB members will continue through periodic meetings during trial implementation to review emerging findings, address implementation challenges, and support dissemination planning. CAB members receive honoraria for their time and expertise, consistent with community-engaged research best practices and institutional policy. 2.3 Intervention Description 2.3.1 Conceptual and Theoretical Frameworks The SMOKE-FREE HOPE intervention is grounded in Social Cognitive Theory (SCT)( 28 ) and the NIMHD Research Framework (socioecological model)( 29 ) to guide both behavioral and structural components of maternal tobacco/nicotine cessation. Our integrated CHW-led intervention builds self-efficacy for tobacco cessation through the following theory-driven mechanisms: 1) Promote outcome expectation by working with a patient and their families in CHW home/telehealth visits to decrease personal and environmental barriers (i.e. smoke-free home) to cessation; 2) Positively affect the socio-structural environment of the patient by CHW home/telehealth visits that reinforce guidance on smoking cessation and health, and engage the household to support quit dates and a smoke-free home, and guide goal setting on decreasing cigarettes/vape sessions before quitting, quit dates, and providing relapse prevention support. Preliminary studies conducted by our group in San Bernardino County highlight maternal tobacco use as a significant concern among low-income and marginalized communities ( 7 , 8 ). Guided by the NIMHD socioecological research framework for interventions in disparity populations, SMOKE-FREE HOPE is designed to address multiple domains and levels of influence. CHWs differ from other professionals by focusing on social support as their core task, including emotional, instrumental (tangible), informational, and appraisal support ( 30 ). Specifically, we integrate CHW home/telehealth visits that provide support using two guidance styles ( 1 ) directive tobacco/nicotine cessation support and ( 2 ) non-directive assistance tailored to patients’ expressed social needs (e.g., housing or food insecurity) ( 31 , 32 ). This approach exerts influence at the individual and interpersonal levels and targets the following domains: behavioral (personal and family functioning), environmental (personal and household), sociocultural (family networks), and the healthcare system (a CHW-led model that extends care into the home). 2.3.2 Overview of Interventions The SMOKE-FREE HOPE pilot feasibility trial tests two CHW-delivered intervention models 1) CHW Brief Intervention (CHW-BI) and 2) CHW Patient Navigation (CHW-PN). Each CHW intervention offers equal CHW attention and consists of eight weekly sessions designed to provide proactive, personalized support for pregnant individuals using tobacco or nicotine products. Both intervention models are grounded in evidence-based cessation strategies and adapted for delivery in home or telehealth settings. CHWs are integrated into the LLUH care models of care and have received orientation on “whole person care”. Additionally, they will undergo formal orientation on the LLUH Institute of Community Partnership on the Integrated CHW Care Model, social determinants of health, cultural competency, and trauma-informed care standardized protocols. Each session includes EMR review, structured content delivery, participant check-ins, and documentation. 2.3.3 CHW Workflow and Integration The integrated CHW services within LLUH and RUHS follow federal guidelines that specify a treatment plan of eight weekly home or telehealth visits, each lasting 60–90 minutes. The standardized perinatal CHW per-visit protocol is grounded in seven core functions: peer support; risk screening; self-management with problem-solving and goal setting; health education; referral and systems navigation; collaboration with the prenatal care team; and community outreach and mobilization, while perinatal CHWs address maternal and child health risk topics as described by Raffo and Lloyd [50]. The integrated CHW coordinates closely with the prenatal care team, typically a social worker and/or public health nurse, to ensure continuity of care and prompt referrals for identified social needs. 2.3.4 Integration of Tobacco/Nicotine Cessation Module For pregnant women who report tobacco or nicotine use and express interest in quitting, SMOKE-FREE HOPE embeds a 10–30-minute cessation module within the standard CHW visit. Both intervention arms, CHW-BI (Brief Intervention) and CHW-PN (Patient Navigation), share core components emphasizing behavioral support and attention to SDOH/social drivers of health. See Table 2 for overview comparison of both arms. View this table: View inline View popup Download powerpoint Table 2. Comparison of CHW-Brief Intervention and CHW-Patient Navigation Models View this table: View inline View popup Table. 3. Overview of CHW Activities Across Eight Weekly Visits in both arms: Arm A (CHW–Brief Intervention) vs. Intervention Arm B (CHW–Patient Navigation) Notes: Both arms include rapport building, ongoing encouragement, monitoring quit status, and relapse support. Arm A is curriculum-driven with SCRIPT® video/workbook and behavioral exercises; Arm B focuses on navigation to external cessation services (Quitline, App or Classes) using the Ask–Advise–Connect approach. At Visit 1 (A home visit is preferred when feasible and acceptable to the participant.), the CHW engages the pregnant participant (and household, when appropriate), provides cessation materials, and encourages immediate reduction in cigarette or vaping use. Together, they will aim to set interim reduction goals and identify Visit 3 as the target quit date. Following Visit 1, the CHW develops a written treatment plan using the DHHS federal format, in collaboration with the CHW supervisor and, when indicated, a social worker or public health nurse. The plan highlights priority SDOH domains (e.g., housing, food security, transportation, behavioral health) and includes tobacco/nicotine use as a key focus area. During Visits 2–8, the CHW provides integrated, goal-driven care that maintains standard CHW functions and maternal–child health content. The cessation module is tailored to progress toward goals, with attention to SDOH barriers (e.g., stress, housing instability, food insecurity) addressed through referrals and systems navigation. After each visit, the CHW documents updates in the electronic medical record (EMR) using a study rubric, noting quit progress, relapse events, and next steps. EMR entries and case conferences ensure coordination with prenatal care providers. Between visits, the CHW remains available by phone to address barriers, reinforce cessation skills, and coordinate urgent referrals. 2.3.5 Intervention Arms 2.3.5.1 CHW-Brief Intervention (CHW-BI) In this “brief advice” arm, the CHW will deliver the evidence-based Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT®) ( 15 , 16 ) program using the 5 A’s framework for smoking cessation ( 33 ). At the first home visit, the CHW introduces SCRIPT® by showing the video, which builds self-efficacy, underscores maternal/fetal/infant risks, and models cessation strategies. Participants then complete the SCRIPT® workbook ( A Pregnant Woman’s Guide to Quit Smoking ; 5th–6th grade reading level; available in Spanish), which covers cutting down, identifying reasons for quitting, understanding smoking cues, creating a stop-smoking contract, trigger identification, engaging a support “buddy,” stress-management (e.g., breathing exercises), managing urges/physical reactions, and coping/aversion techniques. The CHW serves as a health coach, scheduling and reinforcing workbook themes across the remaining seven weeks of the intervention and provides structured relapse support using SCRIPT® materials as needed. [See Table 2 for overview of weekly activities] 2.3.5.2 CHW-Patient Navigation (CHW-PN) In this arm, CHWs provide patient navigation support using the Ask-Advise-Connect approach ( 34 ). CHWs introduce participants to community-based cessation resources including the Kick-it CA (State Quitline www.kickitca.org ), help them choose a quit strategy, and provide accountability and follow-up support. Participants receive printed and digital materials, including the Kick-it CA “Quit Smoking Kit,” and support with downloading the Kickit Smoking or Vaping app. The CHW monitors engagement, addresses barriers, and re-engages participants as needed [See Table 2 for overview of weekly activities]. 2.3.6 CHW Training and Supervision The SMOKE-FREE HOPE training program will prepare CHWs, all of whom will have completed a six-month certification program and the LLUH Institute Community Partnerships orientation program, to deliver both study interventions: the Brief Intervention (CHW-BI) and Patient Navigation (CHW-PN) approaches. Training will be conducted over three days, with Days 1–2 covering shared foundational content and Day 3 focused on arm-specific instruction. 2.3.6.1 Days 1–2: Foundational Training (Both Arms) The first two days will establish core knowledge in tobacco cessation and client-centered communication. On Day 1 , CHWs will complete the Texas A&M Tobacco Cessation for CHWs course (4 CEUs) [35] and review the National Community Health Worker Training Center CHW Toolkit: Tobacco Cessation [36]. Trainers will contextualize the content using California and county-level maternal smoking data, review local cessation resources, and address evidence-based strategies for smoking cessation in pregnancy, including risks associated with secondhand smoke exposure. On Day 2 , training will focus on a review and application of motivational interviewing (MI) and the Stages of Change framework, curriculum. Through guided discussion and role-play based on maternal cessation scenarios, CHWs will strengthen MI skills and client engagement techniques relevant to both intervention arms. 2.3.6.2 Day 3: Arm-Specific Instruction On the final day, CHWs will receive intervention-specific training. 2.3.6.3 Training: CHW-Brief Intervention (CHW-BI) CHWs will complete the SOPHE SCRIPT® Training Bundle (Modules 1–4) [37], which covers screening for tobacco use, application of the Stages of Change model, and delivery of SCRIPT® counselling from initial assessment through follow-up. The session will include practice of SCRIPT® interactions, documentation, and integration of brief cessation counselling into prenatal and community care workflows. CHWs will receive the SCRIPT® Guidelines and Counselling Manual for Prenatal Care [16] for continued reference. 2.3.6.4 Training: CHW-Patient Navigation (CHW-PN) CHWs will be trained to link pregnant clients with local, state, and national cessation resources. Trainers will introduce Kick It California ( https://kickitca.org/ ) and demonstrate navigation of its services (e.g. quit-coach calls, text messaging support, self-help materials, mobile application). Role-play will reinforce motivational dialogue, navigation, and engagement strategies. Training will also cover documentation and follow-up procedures, with CHWs encouraged to contact and, when feasible, observe local cessation programs to strengthen familiarity with available resources. Across the three-day training, the SMOKE-FREE HOPE program is designed to equip CHWs with the competencies required to deliver both study interventions. Upon completion, CHWs will be able to: (1) deliver brief, evidence-based cessation counselling within the CHW–Brief Intervention (CHW-BI) framework, and (2) effectively navigate and reinforce engagement with cessation resources within the CHW–Patient Navigation (CHW-PN) framework. In addition, CHWs will demonstrate culturally responsive communication, accurate referral practices, and capacity for sustained follow-up consistent with the SMOKE-FREE HOPE intervention protocol. 2.3.6.5 Post-training Supervision Process Evaluation Procedures Following CHW training, the PI provides structured supervision and debriefing during the early implementation phase to ensure consistency with the SMOKE-FREE HOPE protocol and to inform ongoing adaptation. Initially, the PI meets with each CHW following home or telehealth visits for the first 10 participants in each intervention arm to review visit content, confirm adherence to required components (e.g., tobacco and nicotine screening, counseling framework, documentation), and identify barriers to delivery or participant engagement. Feedback from these sessions is used to refine and tailor the intervention to participants’ cultural and pregnancy-related contexts. All supervisory interactions, field notes, and observations are documented in secure study files. The PI and program coordinator review these data during weekly team meetings to identify common challenges, support CHW learning, and document any adaptations made during implementation. Major protocol deviations or unanticipated adaptations are discussed with the study leadership team and, if necessary, reported to the IRB. Following implementation and supervision of CHWs, study outcomes will be evaluated through a combination of quantitative and qualitative assessments as described below. 2.4 Outcome Evaluation and Data Analysis 2.4.1 Primary Feasibility and Acceptability Outcomes The primary aim of this pilot study is to evaluate the feasibility and acceptability of the integrated community health worker (CHW)–delivered SMOKE-FREE HOPE intervention. These constructs will be assessed using quantitative process metrics and qualitative inquiry, following established feasibility frameworks and behavior change research ( 35 - 38 ). 2.4.1.1 Feasibility Outcomes Primary feasibility outcomes will include metrics related to recruitment, retention, visit adherence, data completeness, and intervention fidelity: Recruitment rate: The proportion of eligible participants who consent to participate, calculated as the number enrolled divided by the number screened and approached ( 39 ). Percentage screened and referred (EMR): Number of eligible patients identified in EMR, number sent personal invitations and number of “I’m interested” responses ( 40 ). Retention rate: The proportion of participants who complete all three study visits, including the 3- and 6-month postnatal follow-ups ( 41 ). Visit adherence: The proportion of scheduled CHW visits completed within each intervention arm (CHW-BI and CHW-PN). Data completeness: The proportion of complete data collected through electronic records and surveys, including tobacco use assessments and follow-up measures. Intervention fidelity: Fidelity to CHW intervention protocols will be assessed using standardized checklists completed by CHWs after each visit, reviewed by the study team, and supplemented with review of CHW documentation and debrief sessions conducted with the Principal Investigator (PI) and Project Coordinator (PC). 2.4.1.2 Acceptability Acceptability will be assessed through both qualitative and quantitative methods, guided by the Capability, Opportunity, Motivation–Behavior (COM-B) model and associated frameworks ( 35 - 37 ). 2.4.1.2.1 Conceptual Framework The COM-B model, a central component of the Behavior Change Wheel (BCW), has been widely applied in feasibility and acceptability research, including maternal smoking cessation and provider engagement studies ( 35 , 38 , 42 - 44 ). Qualitative data analysis will be guided by the Theoretical Domains Framework (TDF) ( 37 , 45 ) and the BCW, which conceptualize: Capability as physical and psychological components (skills, knowledge, behavioral regulation); Opportunity as physical and social environmental factors; and Motivation as reflective (cognitive processes, intentions) and automatic (habits, emotions, reinforcement) processes. These constructs will be applied to interview and focus group data to explore: The acceptability of the integrated CHW-delivered SMOKE-FREE HOPE intervention; Perceptions of CHWs’ capability to deliver the intervention; and Perceived positive and negative impacts of the intervention. 2.4.1.2.2 Key Informant and Moderator Guides For each intervention arm (CHW-BI and CHW-PN), key informant interviews and focus groups will be guided by standardized protocols addressing: CHW intervention delivery; CHW intervention receipt; Contextual factors influencing implementation; Mechanisms of impact; Satisfaction with the intervention and program; and Recommendations for refinement. 2.4.1.2.3 Participant Surveys Participant surveys will be administered upon program completion. Surveys will assess: The impact of CHW interactions on motivation; The impact of CHW interactions on perceived competence; Satisfaction with CHW visits and interactions; and Responses to adapted measures from: The Critical Factors Survey among pregnant persons ( 46 ); and The Navigation Satisfaction Tool, Part 1 (Pregnant persons) ( 46 ). 2.4.1.2.4 Stakeholder Perspectives Semi-structured moderator guides will be tailored for each stakeholder group, including prospective participants, CHWs, CHW supervisors, referring providers (social workers and public health nurses), and clinic administrators, to capture diverse perspectives on intervention acceptability, perceived feasibility, implementation processes, and design considerations. 2.4.1.3 Contextual Evaluation Understanding the role of context is essential to interpreting feasibility, acceptability, and intervention outcomes. Contextual factors may shape implementation fidelity, mechanisms of impact, and outcome variability across clinical and community settings. Accordingly, we will assess how contextual influences affect: Intervention implementation and delivery; Mechanisms of impact; and Observed outcomes. 2.4.1.3.1 Data Sources and Methods Multiple data sources will be used to examine contextual influences: Program Coordinator and supervisory field notes: Notes from referral encounters and survey visit interactions—supplemented by direct observation field notes from the PI or CHW Supervisor—will be reviewed to identify contextual facilitators and barriers to recruitment, intervention delivery, and data collection. Semi-structured interviews and focus groups: Conducted with: CHWs: To understand delivery experiences, barriers, and facilitators to engagement. An adapted COM-B Assessment Tool based on Warsi et al. (2019) ( 47 ), will be used in semi-structured interviews to assess CHW competence, confidence, and motivation to deliver the intervention. Patients: To explore perceptions of how social, environmental, and health system factors influenced participation and smoking-related behaviors. Clinical and administrative stakeholders: Including medical directors, primary care providers, social workers, public health nurses, clinic administrators, CHW supervisors, and CHW program leadership (LLUH-ICP and Riverside CHW Hub). Interviews will explore system-level contextual factors such as communication processes, staffing models, and leadership support for CHW integration. 2.4.1.3.2 Policy and Systems Review Policies related to CHW integration into primary care, including reimbursement mechanisms, will be reviewed to contextualize implementation facilitators and constraints. 2.4.1.4 Analytic Approach Contextual data will be analyzed using a framework analysis ( 48 , 49 ) approach informed by the COM-B model and Behavior Change Wheel constructs. This approach allows examination of how contextual factors interact with capability, opportunity, and motivation to influence intervention delivery, mechanisms of impact, and outcomes. Findings will be mapped to COM-B domains to identify modifiable contextual influences for future implementation and scale-up. CAB feedback will be integrated as an additional data source to contextualize barriers and facilitators identified by patients, CHWs, and clinic stakeholders, and to co-interpret how local structural and policy environments influence implementation and mechanisms of impact. 2.4.2 Secondary Aims and Outcomes The secondary aim of this pilot is to explore preliminary signals of intervention efficacy on tobacco and nicotine use behaviors and related psychosocial outcomes among pregnant and postpartum participants. These measures will provide insight into potential clinical and behavioral effects and inform outcome selection for a future fully powered randomized controlled trial. Secondary clinical and behavioral outcomes include: Self-reported 7-day point prevalence abstinence: No use of any tobacco or nicotine product in the seven days assessed across baseline, third trimester, and postpartum time points. Biochemical verification of abstinence: Urine cotinine testing approximately one month after the participant’s reported quit date to validate self-reported cessation. Reduction in tobacco use: Change in the number of cigarettes or vape sessions per day among participants who do not achieve full abstinence, assessed across baseline, third trimester, and postpartum time points. Quit attempts: Frequency and timing of quit attempts recorded through self-report and CHW logs during enrollment period. Relapse prevention: Maintenance of abstinence among participants who had quit prior to enrollment, assessed at delivery and postnatal follow-up. Engagement with cessation resources: Utilization of tobacco cessation supports (e.g., quitlines, group counseling, or substance use treatment referrals), particularly in the CHW-PN arm, based on CHW encounter forms and participant surveys. Perceived social support for quitting: Participant-reported support from family, peers, and CHWs, assessed using validated instruments. Postpartum tobacco use status: Smoking and nicotine use status at postpartum, and at 3- and 6-month follow-up visits. 2.4.3 Sample Size and Rationale This two-arm pilot feasibility trial is not powered to detect statistically significant differences between groups. Consistent with guidance from the NIDA Stage Model for early behavioral treatment development, recommends approximately 15 participants per arm to evaluate feasibility parameters, the target sample size is 30 participants total (15 per arm) . This sample will allow estimation of recruitment, retention, and fidelity metrics. Allowing for attrition, up to 50 participants may be enrolled to ensure that approximately 60 complete all study procedures. No formal power calculation was conducted; instead, interpretation will focus on the estimation of feasibility, acceptability, and fidelity measures. 2.5 Measures and Data Management An overview of assessments, surveys and bio-specimen measures is outlined in Table 1 . All survey data will be administered by program coordinator verbally or electronically using a secure database or REDCap portal, accessible during scheduled study visits, which automatically timestamps entries, restricts access to authorized users, and stores data on LLUH’s secure, firewall-protected servers. CHWs will document on hard copies and enter The primary efficacy outcome is 7-day point-prevalence tobacco/nicotine abstinence, assessed by both biochemical verification (urine cotinine) and self-report using validated items. These measures will capture cessation status across all tobacco and nicotine product types, including combustible, electronic, smokeless, and heated products. Biochemical verification of self-reported seven-day point prevalence abstinence will be conducted following established procedures by Benowitz et al.( 50 ). Urine samples will be collected at LLUH outpatient laboratory and analyzed for cotinine concentration by the LLUH Laboratory Services using liquid chromatography–tandem mass spectrometry (LC/MS/MS) methodology( 51 ). In addition to biochemical verification, self-report measures will assess number of cigarettes smoked using the modified Cigarette Evaluation Questionnaire (m-CEQ), number of quit attempts ( 52 ), and level of cigarette dependence using the Fagerström Test for Cigarette Dependence (FTCD) ( 53 ) or adapted Fagerström measures for other tobacco or nicotine products, i.e., e-cigarettes/vapes, smokeless ( 53 - 56 ). Product consumption patterns, and use of flavored product use and quit attempts since enrollment will be assessed using validated tools. Tobacco use history and dependence will be assessed through age of initiation, history of quit attempts, prior nicotine replacement therapy (NRT) or pharmacotherapy use, and product switching. Nicotine dependence will be evaluated using validated single- and multi-item measures: the Fagerström Test for Cigarette Dependence (1-item version for cigarettes), the 2-item Penn State Nicotine Dependence Index for e-cigarettes, and the 1-item Fagerström for smokeless tobacco ( 53 - 56 ). Additional substance use assessments include use of cannabis (mixed or without tobacco) ( 56 ), and the AUDIT-C ( 57 ) to assess alcohol consumption. Finally, constructs from the Social Cognitive theory will be explored using adapted validated measures. These measures will evaluate self-efficacy to remain tobacco/nicotine-free, perceived social support for non-tobacco use, intrinsic motivation to quit, perceived risks and benefits to self and baby, and readiness to quit ( 58 - 61 ). Clinical and contextual factors will be obtained from the electronic medical record (EMR) and participant report. EMR-derived measures include maternal medical and psychiatric history, depression screening results, prenatal care history, delivery and newborn outcomes, and maternal/fetal morbidity and mortality indicators. Household context (number of smokers in the household and presence of smoke-free-home rules) will be collected, along with demographic and mental health variables ( 62 ), including age, sex/gender, race/ethnicity, education, income, participation in public assistance programs, food insecurity, access to healthcare, and brief mental health screening items. Findings from these exploratory analyses will complement feasibility and acceptability results, contributing to a comprehensive assessment of preliminary intervention effects and informing refinement of outcomes and measures for future research. 2.5.1 Data Management and Security All data collected through the SMOKE-FREE HOPE program will be managed using secure, standardized procedures to protect participant confidentiality and ensure compliance with institutional and federal data protection policies. Trial data will be entered directly into REDCap, a secure, cloud-based database serving as both the clinical chart and survey platform. Data entry will occur on password-protected, encrypted study laptops or tablets assigned to CHWs. All electronic data will be stored on firewall-protected servers maintained by Loma Linda University Health (LLUH), with REDCap enforcing role-based access control, automatic timestamping, and user authentication. Any physical documentation related to CHW visits, key informant interviews, or focus groups—as well as audio recordings—will be stored in locked cabinets within the Principal Investigator’s secured office at the Loma Linda University School of Nursing. Keys will be kept in a separate locked drawer. All Protected Health Information (PHI) will be managed using a coded participant identification number (PID) system to remove direct identifiers. A master linkage file connecting names to PIDs will be maintained separately on a password-protected computer accessible only to the PI and designated study personnel. Signed consent forms, HIPAA authorizations, and incentive receipts will display only the PID. Audio recordings will be labeled with PIDs and transcribed by a HIPAA-compliant transcription service approved by LLU Information Security. Transcripts will be de-identified and labeled solely by PID before analysis. All biospecimens and electronic survey data will likewise be linked by PID only; no personal identifiers will appear on laboratory samples or exported datasets. 2.5.2 Data Retention and Destruction De-identified research data (REDCap datasets, analysis files, and study documentation) will be retained on LLUH secure servers for at least 7 years after study completion or last publication, whichever is later, consistent with institutional policy and federal guidance. Audio recordings will be deleted after verified transcription and quality checks are complete; only de-identified transcripts labeled by PID will be retained. Paper records (e.g., consent forms) will be stored in locked cabinets and retained for the same period, then destroyed by confidential shredding. Biospecimens will be retained only until planned assays and quality control are complete, then disposed of per LLUH biosafety procedures; no specimens will be used for secondary analyses without additional IRB approval and consent, if required. System backups will follow LLUH IT policies; access logs and role-based permissions will be reviewed periodically. Any future data sharing will use de-identified datasets under a Data Use Agreement and IRB/Privacy oversight. 2.5.3 Statistical Analysis Analyses are designed to address the primary feasibility and acceptability aims and to estimate preliminary effects for secondary outcomes. Feasibility metrics (recruitment and retention) will be summarized descriptively. Drawing from prior CTTP cohort data, recruitment exceeding 30% of eligible participants approached and retention above 56% will be considered feasible. Acceptability will be assessed through participant satisfaction Likert scores and compared descriptively with normative data from earlier CHW interventions among post-surgical patients. CHW and healthcare-provider (HCP) interview data will be explored qualitatively and compared descriptively to findings from similar CHW-based programs. For secondary (exploratory) clinical and behavioral outcomes, analyses will prioritize effect-size estimation with 95% confidence intervals. Cotinine-verified 7-day point prevalence abstinence (PPA) at 1, 3 and 6 months will be compared between arms and summarized as risk ratios (RRs) with 95% CIs; an RR ≥ 1.4 (from pooled estimates in pregnancy cessation meta-analyses) will be treated as a heuristic signal for potential efficacy. Continuous abstinence will follow Russell criteria with Urine Cotinine verification among self-reported abstainers; time-specific PPA will also be estimated at 1 week, 1 month, and 3 months post-quit date. Longitudinal abstinence trajectories (quit date through postnatal follow-up) will be examined using generalized linear mixed-effects models (GLMMs) adjusting for baseline tobacco use/dependence. Secondary behavioral outcomes (cigarettes/day, quit attempts, FTCD) will be summarized descriptively and examined for within-participant change and trajectories over time (paired tests and GLMMs) to inform variance and design parameters for a definitive trial. Where hypothesis tests are reported for exploratory endpoints, they will be two-sided with α=0.05. Analyses will follow an intent-to-treat framework where feasible. Missing data will be addressed via multiple imputation under a multivariate-normal framework, with sensitivity analyses under both missing-at-random and “missing-implies-smoking” assumptions. All analyses will be conducted in R (v3.4.2) and SAS (v9.4; Cary, NC). 2.5.4 Data Integration and Synthesis of Findings A convergent mixed-methods design ( 63 , 64 ) will be used to integrate quantitative and qualitative findings related to feasibility, acceptability, and contextual influences. Quantitative data, including recruitment, retention, adherence, data completeness, and fidelity metrics, will be analyzed using descriptive statistics (means, proportions, and 95% confidence intervals) to characterize study processes and identify operational challenges. Qualitative data derived from interviews, focus groups, field notes, and policy reviews will be analyzed using a framework analysis approach guided by the COM-B and Behavior Change Wheel constructs ( 48 , 49 ). Coding will proceed inductively within each data source and then be mapped deductively to COM-B domains (capability, opportunity, motivation). This dual analytic process will allow identification of recurrent themes, contextual variations, and perceived mechanisms of impact across stakeholder groups. Quantitative and qualitative results will be merged using joint display matrices to compare, contrast, and triangulate findings, supporting interpretation of convergence, complementarity, and divergence across data sources. This integrative analytic process will provide a comprehensive understanding of how contextual and implementation factors influence study feasibility, participant engagement, and potential mechanisms of impact. Integrated findings will be collaboratively reviewed with the Community Advisory Board (CAB) to ensure community relevance and to guide refinement of the SMOKE-FREE HOPE intervention, CHW training, and study procedures. Rather than specifying formal progression criteria, this synthesis will generate actionable insights to inform intervention refinement, optimize implementation strategies, and guide potential scale-up in future phases of research. 2.6 Ethics, Oversight, and Monitoring 2.6.1 Ethical Considerations and IRB Approval The SMOKE-FREE HOPE study protocol, including all participant recruitment, consent, and data collection procedures, was reviewed and approved by the Loma Linda University Institutional Review Board (IRB) (Approval No. 5220112). The study was determined to involve minimal risk and was approved under the category of research involving behavioral interventions with pregnant individuals. All research activities are conducted in compliance with federal regulations governing human subjects research (45 CFR 46), institutional policies, and ethical principles outlined in the Belmont Report. Prior to implementation, all study materials, including recruitment scripts, consent forms, CHW training manuals, interview guides, and participant surveys, were submitted for IRB review and approval. Additionally, all compensation levels were reviewed/approved by the IRB and are within norms for pregnant participants in behavioral trials. Any subsequent protocol amendments or modifications will be submitted to the IRB for review and approval before implementation. All research staff, including CHWs, have completed LLU IRB training in human subjects protection and HIPAA compliance. Participants are informed that their participation is voluntary and that their decision to participate or withdraw will not affect their medical care or access to community services. 2.6.2 Adverse Event Reporting and Participant Safety Adverse events (AEs) and serious adverse events (SAEs) will be identified, documented, and reported throughout participation in the SMOKE-FREE HOPE program using a standardized process. CHWs, program coordinators, and research staff will assess for potential AEs at each home or telehealth visit and during follow-up contacts (phone, text, or electronic message). Participants will also receive a dedicated study contact number to report symptoms between visits. An AE is defined as any unfavorable medical, psychological, or social occurrence during participation, whether or not related to the intervention; an SAE is an event resulting in hospitalization, a life-threatening condition, persistent disability, congenital anomaly, or death. All reported events will be reviewed by the PI and the study’s Medical Director for seriousness, severity, expectedness, and relatedness. Given the behavioral/supportive nature of the program, most anticipated events are minor (e.g., transient mood changes, nicotine withdrawal symptoms, headache, dizziness, or emotional distress during counseling). All AEs and SAEs will be recorded using standardized forms that capture onset, duration, severity, outcome, and actions taken. SAEs judged related to the intervention will be reported to the IRB within three business days of awareness; all other SAEs will be reported within fifteen calendar days. Participants experiencing serious or unexpected intervention-related events will discontinue the intervention phase for safety monitoring but will remain in follow-up for outcome assessments when feasible. Each AE will be followed until resolution or stabilization, with medical evaluation or referral arranged as indicated. Periodic summaries of AEs will be reviewed by the DSMC and included in annual reports to the IRB. 2.6.3 Data and Safety Monitoring Committee (DSMC) and Trial Oversight Monitoring procedures include ongoing adverse event reporting and independent oversight of participant safety by a Data and Safety Monitoring Committee (DSMC). 3 Dissemination and Knowledge Translation The CAB will be engaged as partners in dissemination planning and execution, including co-development of plain-language summaries, community briefings, and practice-oriented toolkits for CHWs and clinics. Where appropriate, CAB representatives will be invited to co-present findings to local health systems and community forums and to advise on policy-relevant messaging (e.g., CHW reimbursement and integration). This approach ensures that dissemination products are accessible, actionable, and aligned with community priorities. The findings will also be presented at scientific meetings, and findings reported in peer-reviewed journals. 4 Discussion 4.1 Summary of Contribution Prior work conducted in the United States has examined CHW-supported tobacco cessation in general and underserved populations ( 10 - 12 , 65 , 66 ), and among adults with serious mental illness ( 67 ) and chronic conditions ( 68 ); to our knowledge, this is the first trial to integrate CHWs into prenatal care to deliver tobacco and nicotine cessation support explicitly tailored to pregnancy. By targeting pregnancy-specific mechanisms (e.g., household smoke-free rules, relapse risk across trimesters, dual use of e-cigarettes and combustible products) and leveraging CHWs’ strengths in social-needs navigation, this approach extends prior CHW cessation models to a perinatal context. 4.2 Anticipated Challenges and Mitigation Strategies Due to well documented under-reporting of tobacco and nicotine use and tobacco-related stigma in pregnancy ( 69 - 71 ), and additional challenges associated with pregnancy, recruitment and retention of pregnant individuals who use tobacco or nicotine are anticipated to be the most significant challenges. However, this study builds on the lessons learned from prior maternal services provided by LLUH (CTTP) and the established referral base. Additionally, to enhance reach and engagement, the study uses multiple recruitment pathways, electronic medical record screening and invitations, provider referral, and community outreach, and the intervention will be implemented by trusted CHWs using tailored materials and flexible scheduling (telehealth or home visits). Additionally, small, activity-linked incentives and brief check-ins by CHWs and program coordinator are intended to support adherence without undue influence. Variability in CHW delivery represents another foreseeable barrier. This is addressed through standardized training, early and ongoing supervision, and fidelity monitoring using structured checklists, electronic documentation, and regular debriefs. These procedures are designed to ensure protocol adherence while allowing contextual adaptation consistent with a pilot feasibility framework. Data completeness, particularly for biospecimens used to verify abstinence, may be affected by participant burden. To mitigate this risk, the program coordinator will work closely with participants to schedule surveys at convenient times for participants and flexible specimen collection options will be provided. Integration within busy prenatal workflows may also pose logistical difficulties; these are mitigated through EMR templates, multiple referral options (e.g., referral menu, website) and tip sheets for referring providers. Finally, social and structural barriers such as housing instability, food insecurity, and co-occurring substance use may compete with cessation goals. The intervention addresses these through CHW-led screening and navigation to community resources and by applying trauma-informed, strengths-based counselling. Recognizing the evolving tobacco exposome, CHWs are trained to address e-cigarette and dual-use behaviors using adapted assessment tools and tailored counselling. 4.3 Implications for Future Research By integrating behavioral and social support within CHW-led perinatal care, SMOKE-FREE HOPE seeks to enhance engagement, retention, and long-term cessation among priority populations at highest risk for adverse birth outcomes. Feasibility and acceptability data from this pilot will be critical for refining the intervention, optimizing content and delivery mechanisms, and identifying implementation strategies for scaling within Federally Qualified Health Center (FQHC) networks. Ultimately, findings from this pilot trial will inform the design of a larger randomized controlled trial aimed at improving maternal and infant health equity through sustainable, community-driven tobacco cessation strategies. Data Availability The data supporting this research are available from the authors on reasonable request. Declarations Ethics approval and consent to participate Ethical approval has been granted from Loma Linda University Health Institutional Review Board (Approval No. 5220112), and an IRB Authorization Agreement between LLUH and Riverside University Health System (IRB Reg. number: 0000383) prior to commencing the study. Any protocol amendments will be submitted to the LLUH IRB for approval. Consent for publication Non-applicable Availability of data and materials The data supporting this research are available from the authors on reasonable request. Competing interests The authors declare they have no competing interests. Funding This research is supported by the Tobacco-Related Disease Research Program of the University of California Office of the President, Grant Number T32KT4784. Author contributions ABP and PNS drafted the initial protocol. BO designed the maternal tobacco cessation program (CTTP) that informs this intervention. JT provided expert guidance with the development of intervention and community health worker training. JCB developed the integrated community health worker model developed within LLUH and informed the integration of the CHW role in this model. All authors contributed to the conception and design of the final protocol. Acknowledgements We thank the Smoke-Free HOPE Community Advisory Board members for their sustained guidance and partnership in the development and implementation of this study. We are grateful to the leadership and clinical teams at Loma Linda University Health (LLUH) Maternal–Fetal Medicine and Riverside University Health System (RUHS) Women’s Health Center for ongoing support integrating study procedures into clinical operations. 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Share Smoke-Free Household and Parent Program (Smoke-Free HOPE): Protocol for a Pilot Feasibility RCT Integrating CHWs into Prenatal Care for Maternal Tobacco Cessation Anne Berit Petersen , Berenice Rosas , Juan Carlos Belliard , Janice Tsoh , Bryan Oshiro , Ruofan Yao , Pramil N. Singh medRxiv 2025.10.26.25338756; doi: https://doi.org/10.1101/2025.10.26.25338756 Share This Article: Copy Citation Tools Smoke-Free Household and Parent Program (Smoke-Free HOPE): Protocol for a Pilot Feasibility RCT Integrating CHWs into Prenatal Care for Maternal Tobacco Cessation Anne Berit Petersen , Berenice Rosas , Juan Carlos Belliard , Janice Tsoh , Bryan Oshiro , Ruofan Yao , Pramil N. 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