Tobacco smoking remains the leading cause of preventable morbidity and mortality in the United States, contributing to approximately 480,000 premature deaths annually [1]. This comes at a high economic cost to our society. Data from a recent national report showed that smoking-related illnesses cost the United States over US $600 billion in 2018 [2]. Evidence-based smoking cessation treatments (EBCTs) are greatly underused by people who smoke. For example, the use of state quitline coaching programs and pharmacotherapy enhances smoking quit attempts and cessation [3], but many people who smoke are unaware of or do not use state quitlines [4-6]. Schauer et al [7] analyzed data from the 2009 to 2010 National Adult Tobacco Survey and found that quitline awareness was 53.9% among people who smoke. Further, among individuals who attempted to quit smoking in the past year and had knowledge of the quitline's existence, their use rate was only 7.8%. Therefore, efforts to improve access, information, and acceptance of EBCTs are required.

Significant rural-urban disparities exist in the United States concerning tobacco smoking, smoking-related health outcomes, and smoking cessation treatment access. Adults who live in rural areas of the United States have among the highest tobacco smoking rates in the nation and experience a higher prevalence of smoking-related deaths and deaths due to chronic diseases for which smoking is a causal risk factor [8]. Trends from the last several years show that rural areas experience higher rates of smoking-related chronic diseases than their urban counterparts [9,10]. Compared to urban residents, people living in rural areas are generally older, have lower adherence to preventative screening [10-12], and face significant treatment barriers related to social determinants of health, which puts them at a higher risk of developing chronic diseases [13,14]. A lack of health care specialists in rural areas further exacerbates these barriers to seeking care [15,16]. For example, a recent study by the Centers for Disease Control and Prevention (CDC) found that people living in rural areas had lower rates of cancer diagnoses but experienced higher death rates for all cancer types when compared to people living in nonmetropolitan and metropolitan areas, highlighting rural patients’ challenges in accessing necessary health care [17]. Rural communities face tobacco-related disparities that expose them to difficulty seeking access to smoking cessation treatment support, ultimately leading to a higher prevalence of chronic diseases. For example, rural communities have a higher rate of cigarette smoking than urban areas, a trend observed for both women (rural vs urban: 25% vs 13%) and men (rural vs urban: 29% vs 19%), but tobacco control policies and cessation efforts tend to favor urban areas more than rural areas [8]. Due to difficulties such as geography, infrastructure, and corporate barriers, those living in rural areas have difficulty accessing tobacco cessation services [8].

One approach for improving access and overcoming barriers to engagement in underserved populations is through the use of digital technology and social media platforms. There has been a growing recognition that leveraging digital technology could encourage the positive behavior change necessary to quit smoking and manage chronic conditions like cancer and heart disease. By doing so, barriers that impede access to EBCT can be lessened [18]. For example, the use of social media, such as Facebook, could be used to deliver smoking cessation behavioral interventions such as motivational interviewing (MI) and peer support and encourage the use of EBCT interventions. Facebook is the most used social media platform in the United States and has a broad reach. It promotes engagement and connection among peers that can be used in smoking cessation efforts at a relatively low cost. In addition, Facebook is a helpful tool for supporting smoking cessation through online communication and sharing of experiences among users. The experience allows users and study staff to share intervention-related pictures, videos, and images to encourage discussion. This represents a distinct advantage over face-to-face approaches or web-based services [19,20]. In recent years, many studies have used social media, including Facebook, for smoking cessation interventions. However, the use of Facebook to deliver EBCT with a faith-based component developed by the community-based participatory research (CBPR) approach is lacking.

Another approach to improve access and uptake of evidence-based interventions is by culturally adapting them to fit the specific needs and contexts of individuals who underuse them. Studies have shown that the implementation of EBCT with community co-design and engagement enhances its receptivity and uptake [21]. One such effective approach is CBPR, a model that equitably involves community members, organizations, and academic researchers in all aspects of the research process. As a result, all partners can contribute their expertise with shared ownership and responsibility; knowledge gained is enhanced, and action is integrated to improve community members’ health and well-being [22]. Evidence also shows that culturally relevant messaging delivered through CBPR approaches increases [23,24] study recruitment, EBCT resources acceptance, and cessation rates [25-27]. This approach is particularly important for hard-to-reach marginalized rural populations, by empowering them to be agents of maintained change in their communities. Therefore, our study will use the CBPR strategy to center rural end users to co-design the intervention to promote its maintainability and lasting impact in the rural community.

Numerous research studies have evaluated the effect of spirituality and religious beliefs on positive health behaviors. For example, these beliefs may help to reduce stress through engagement with coping skills and lifestyle factors such as improved diet, attendance to preventive care, exercise, and reduction in alcohol drinking, and so forth, which ultimately improves cardiovascular health and general well-being [28-31]. In addition, many studies have shown a negative correlation between faith-based involvement and cigarette smoking [32-37]. Research suggests that individuals participating in faith-based activities are less likely to smoke or begin smoking in the future [37,38]. Whooley et al [37] found that nonsmoking individuals who attended religious services less than once a month were at twice the risk of starting smoking compared to those who attended services regularly over 3 years. In addition, a study conducted by Kim et al [39] among Korean men found that church attendance may assist individuals in quitting smoking due to social prohibitions from other members of the congregation. The mechanism behind this phenomenon is theorized that religious attendance offers spiritual support, an essential source of resiliency, and reduces stress [31] that would otherwise perpetuate cigarette smoking [40]. In addition, faith-based congregants may provide peer support in the smoking cessation journey [31,41]. Since religious participation offers an avenue for smoking cessation and the faith-based CBPR approach has not been thoroughly evaluated among the rural population for smoking cessation, our study attempts to fill this research gap.

Participants’ access to clinical trials in rural areas can be a challenge due to transportation barriers in traveling to clinical trial centers and the difficulties associated with spending several hours away from daily wages to participate in research studies. Therefore, participation rates in rural substance use treatment clinical trials are low. Decentralization of clinical trials using digital tools, as we propose in this study, could mitigate this problem.

In this report, we describe a study protocol focused on developing and beta testing an innovative faith-based Facebook intervention for rural smokers. The overall objective of this study is to develop a private, moderated, faith-based Facebook group intervention platform using peer and pastoral support for rural people who smoke to enhance the use and reach of existing EBCT resources.

Our study-specific aims are (1) to describe the process we will use to develop a faith-based Facebook group intervention for smoking cessation that promotes access to and use of EBCT using the CBPR approach and (2) to assess the preliminary feasibility and uptake of the intervention with a 1-month beta test.

We will use the Integrated Theory of Health Behavior Change (ITHBC) [42] and surface or deep structure [43] frameworks as guidance for intervention development (Figure 1). According to the ITHBC framework, an individual is more likely to engage in a behavior change when they understand the disease-related risk factors they are indulging in and if treatment recommendations (including minimizing risk factors) align with their personal beliefs. Therefore, the content of our intervention will be evidence-based (EBCT in this case) and will be prepared to increase the participants’ knowledge about chronic diseases and their risk factors, such as smoking, to enhance their self-efficacy, outcome expectations, and goal congruence.

Self-regulation, a second key factor in making a behavior change, may be enhanced through increased knowledge and reflection on one’s beliefs. Self-regulation involves setting goals, monitoring, reflecting, decision-making, planning, execution, self-evaluation, and managing emotions during change. We will design intervention content to facilitate self-regulation through Facebook posts aimed at increasing knowledge about smoking cessation content (eg, thoughts, intentions, and actions) in congruence with faith-based beliefs.

The third construct, social facilitation, involves social support that encourages behavior change. Participants will receive supervised social support through Facebook engagement with peers on the same journey of smoking cessation. Before the desired outcome (distal outcomes) of smoking cessation, the individual will engage in several self-management behaviors (proximal outcomes), such as calling the state quitline and engaging in Facebook conversations and posts that take them to their final or distal outcome of smoking cessation. For this study, we plan to develop an intervention that will target proximal outcomes (distal outcomes not the scope of this study) of self-management behaviors, measured by actions such as calling a quitline and engaging in Facebook conversations and posts. As noted earlier, since proximal outcomes are influenced by an individual’s knowledge, beliefs, and self-regulation skills, we will use evidence-based material and faith-based messages to facilitate proximal outcomes.

To ensure our messages are culturally aligned and faith-based, we will use the surface and deep structure framework [44,45]. Surface structure considers observable social and behavioral characteristics of participants, such as race, gender, and family structure, while deep structure takes into account cultural beliefs and values. Finally, we will use a planning framework based on the CDC recommendations for developing social media and other digital health communication tools [46] to guide the critical content components of Facebook messages, consistent with behavioral therapy.

The study will use the CBPR approach and will be conducted at Mayo Clinic Health System, Eau Claire, Wisconsin. Before the start of the study, several small-group in-person and online meetings were held in the community with faith-based leaders of local churches to gauge their interest in forming a partnership and brainstorming the study idea. The local faith-based leaders agreed to collaborate and participate in the review of the study design and intervention materials and provide general input on faith-based topics. The pastors were informed that they will be part of the “core research team” and will approve documents including manuscripts, flyers, and other materials before publication and community dissemination. Our other partners for this study included the Mayo Clinic Center for Clinical and Translational Science (CCaTS), community engagement and rural health programs, and the Center for Health Equity and Community Engagement Research (CHCR) that will facilitate the formation of a community advisory board (CAB) and engage the services of the community engagement (CE) studio to get community feedback on the development of the intervention.

Aim 1 will have 2 CAB meetings and 1 CE studio session. Members will be asked to provide helpful feedback on the content's flow, understandability, and relevance. Detailed notes will be taken during these meetings, and an iterative, inductive content analysis approach will be used to identify themes. A total of 2 investigators will work together to code the responses, and a third investigator will resolve any disagreements until a consensus is reached. Aim 2 will summarize sample characteristics, social media usability measures, and most and least preferred concepts using descriptive statistics, including means, percentages, and frequencies. Open-ended responses will be summarized, and themes will be generated using content analysis as described in aim 1.

Because assigning missing data as smoking is not necessarily a conservative approach [57], we will also explore multiple imputation methods [58,59] to classify lost to follow-up as cigarette smokers or nonsmokers and conduct sensitivity analyses as appropriate.

The study was deemed exempt by the Mayo Clinic Institutional Review Board (23-000837). The CAB members will receive a US $150 honorarium. CE studio community experts will receive US $50. The participants will receive US $25 for completing the baseline assessment and US $25 for the postintervention assessment. For the beta test phase, study data will be deidentified.

Our study focuses on collaborating with community stakeholders to co-design a faith-based, peer-supported Facebook-delivered intervention prototype to address smoking cessation among rural people who smoke. This study is essential to a self-maintaining smoking cessation program for the rural population. We believe that Facebook group moderation is an important component of this program to increase participant engagement and provide behavioral support and access to cessation treatment resources and service linkages when required. In addition, the supervised Facebook group may lead to better peer support among participants who can learn from each other’s experiences and share their smoking cessation journey.

No such Facebook group exists that uses faith-based support as a component and encouragement to use EBCTs such as quitlines and cessation pharmacotherapy. During the preliminary meetings, our community stakeholders have shown interest in being trained as moderators and ensuring the continuity of the proposed Facebook group so that the intervention is self-maintained within the community once the study is over.

Our sample is restricted to the Midwest population and stakeholders, which may limit the generalizability to other rural populations. However, this phase is focused on prototype development, and future pilot study steps will pave the way toward larger, more generalizable evaluations of digitally enhanced interventions. Our study will recruit individuals with access to the internet and smart devices to access Facebook, which may lead to selection bias. For future studies, investigators may consider providing a loaner digital device to participants with no digital access to eliminate this selection bias.

Our study will provide preliminary steps, including possible challenges before the RCT for a faith-based, Facebook-delivered EBCT intervention for rural populations that smoke. Our study has a broader interest in faith-based stakeholders and potentially be self-maintainable within the community. This approach can potentially support rural communities by granting them access to community-based health care that is maintainable. Our study design has the capability to provide a tailored online intervention with fidelity. Furthermore, our study uses existing federal and state EBCTs, using available resources to aid in smoking cessation.