Development of a gender-relevant tobacco cessation intervention for women in Brazil—an intervention mapping approach to planning

Abstract

The purpose of this article is to describe the development of a theory-based, culturally and gender-relevant Community Health Worker (CWH)-led tobacco cessation intervention for low-income Brazilian women who augments the tobacco cessation program offered through the public health system using Intervention Mapping (IM). We began with the establishment of a network of representatives from different segments of society followed by comprehensive needs assessments. We then established a logical planning process that was guided by a theoretical framework (Social Cognitive Theory) and existing evidence-based tobacco cessation programs, taking into account socio-political context of a universal health care system. Given the gender-relevance of our intervention and the importance of social support in tobacco cessation among women, we chose an intervention that would be delivered within the public health system but augmented by CHWs that would be trained in behavior change by researchers. One of major advantages of utilizing IM was that decisions were made in a transparent and supportive manner with involvement of all stakeholders throughout the process. Despite the fact that this process is very taxing on researchers and the health care system as it takes time, resources and negotiation skills, it builds trust and promotes ownership which can assure sustainability.

Introduction

The development of interventions to promote behavior change toward engagement in healthy lifestyles (including tobacco cessation) is complex. In broad terms, it involves three key components: needs/asset assessments, intervention development and evaluation at multiple levels, taking into account the specific context at the individual, organizational, community and policy levels [1–3]. While the development, implementation and evaluation of evidence-based interventions are needed toward health promotion and disease prevention, particularly among sub-populations experiencing health disparities, documentation of the systematic process used to organize such interventions is critical. This process can inform the rationale behind the objectives, expected outcomes and approach as well as the theoretical foundation to promote behavior change within a particular context, which, in turn, can aid researchers and practitioners in the development and adaptations of new and existing interventions [1, 4].

A growing number of tobacco cessation interventions have shown to be effective/efficacious in a variety of settings [5–8]. However, most of these interventions are gender neutral, despite the fact that gender-relevant tobacco control efforts is outlined as a priority in the World Health Organization Framework Convention on Tobacco Control and other landmark documents [9]. It has been well documented that, although women smoke less, they experience greater difficulties in quitting, are less likely to quit, and are more likely to relapse than men [10–12]. While the addictive and automatic components of tobacco use are similar for both genders, women, as compared with men, are more likely to smoke to define their own identity and for emotional reasons such as coping with negative emotions and stress, relaxation and to use smoking to facilitate socialization [13–15]. Most of the tobacco cessation programs geared toward women have been done in the context of pregnancy [16–18] and/or consisted of preliminary/pilot studies using quasi-experimental designs [19–22]. To our knowledge, there has been one gender-relevant study that examined the efficacy of a nurse-managed tobacco cessation intervention delivered by lay individuals among low-income women attending federally qualified primary care and women’s health clinics in the Appalachia region of the USA with significant results [23]. Hence, the need to examine the efficacy of theory-based, gender- and culturally relevant tobacco cessation programs, particularly in low- and middle-income countries where the burden of tobacco-related diseases among women is on the rise [24–26].

Intervention Mapping (IM) is a methodological tool that is very useful in the development of evidence-based programs, particularly in pragmatic group randomized trials that are developed, implemented and evaluated in real settings taking into account sustainability since its inception [27, 28]. IM encompasses six steps in intervention development [29]: (1) needs assessment—this step implies an assessment of the at risk population by reviewing relevant literature related to the health issue, as well as collecting new information from all involved stakeholders to have a deeper understanding of attitudes, beliefs and behaviors as well as organizational and community context; (2) delineating performance objectives—this step specifies ‘who and what will change as a result of the intervention’. Performance objectives and outcomes are determined and the target audience is well defined, including inclusion/exclusion criteria; (3) selecting theory-based intervention methods and strategies—Once the objectives, outcomes and target audience are identified, the research team confers on the methods and how they can be organized to be consistent with the theoretical framework and proposed objectives/outcomes; (4) developing a program plan—this phase consists of operationalizing the strategies established under step 2 to concrete implementation plans; (5) planning for adoption in implementation—this step consists of actual implementation of the intervention and all of the necessary components taking into account the context in which the intervention will be implemented and (6) creating evaluation plans—encompasses both process (treatment fidelity) and outcome evaluation (impact of the intervention in the target population).

Despite its usefulness, there is a scarcity of studies using IM in the development, implementation and evaluation of tobacco cessation programs, and, as noted, most of them are gender neutral [30–32] or focus on youth [33, 34]. Therefore, the purpose of this article is to describe the development of a theory-based, culturally and gender-relevant Community Health Worker (CHW)-led tobacco cessation intervention for low-income Brazilian women that augments the tobacco cessation program offered through the public health system using IM.

Methods

Step 1: needs assessment of health behavior

We acknowledge that a tobacco cessation program occurs within a political, social, organizational and community context that should be considered in intervention development. Toward this goal, we conducted a comprehensive and encompassing needs/assets assessment from a socio-ecological perspective at five target levels: intrapersonal, interpersonal, organizational, community and society/policy [2, 3]. These extensive assessments consisted of seven major activities: (1) establishment of a network with representation from different segments of society (e.g. teachers, health care professionals and tobacco farmers) to guide researchers on definition of priorities, interpretation and dissemination of findings; (2) literature review with a particular focus on gender-relevant tobacco cessation programs; (3) cross-sectional population-based survey with cluster sampling (n = 2153) to determine tobacco use prevalence and associated factors among adult women in the state [35]; (4) comprehensive diagnosis of the tobacco cessation program delivered through the public health system which consisted of interviews with administrators at the state, municipal and clinic levels (n = 81), health care professionals directly involved in the delivery of the program as well as the ones who were trained but were no longer involved in the delivery of the program (n = 118), and patients who participated in the Tobacco Cessation Program at Basic Health Units (BHUs) (n = 69) [36–38]; (5) review of federal and state guidelines regarding delivery, format and content of tobacco cessation programs; (6) focus groups with women who were current/former tobacco users, segmented by women who participated in the tobacco cessation program through the public health system and women who did not (n = 48) to better understand barriers and facilitators to tobacco initiation, maintenance and cessation and (7) qualitative interviews with CHWs (n = 6) to better understand their current roles as well as feasibility of incorporating these professionals in a future tobacco cessation program.

It should be noted that these assessments were implemented sequentially to inform the next phase. For example, although the network identified tobacco cessation as one of the priorities, they emphasized the importance of gathering the data at the population level (cross-sectional population-based survey). This, in turn, prompted a comprehensive diagnosis of the tobacco cessation program that was delivered within the public health system. Once the diagnosis was concluded and discussed with the network, it became clear that an intervention augmented by CHWs would be a possibility. Hence, the need for additional data collection, including focus groups with the target audience and interviews with CHWs.

Step 2: definition of program objectives

Based on the results of the needs/assets assessments and network feedback, we moved to the next step, which consisted of determining performance objectives, strategies and expected outcomes as well as defining the target audience considering the individual, community, organizational and policy contexts [39]. It should be noted that at the ‘individual level’ (women current tobacco users), the intervention strategies were based on the US Public Health Service Treating Tobacco Use and Dependence Clinical Practice Guidelines [40] and organized taking into consideration the three major tobacco cessation stages: motivate participants to quit, develop and promote adherence to their quit plan and prevent relapse and promote long-term abstinence from a gender-relevant perspective. At the ‘CHW level’, capacity building objectives and strategies were based on the results of the needs/assets assessments as well as our experience in the capacity building of CHWs in a variety of settings [41–44]. At the ‘organizational level’, objectives and strategies were based on the results of the needs/assets assessments and focused on equipping these health care providers with additional knowledge and skills on cognitive-behavioral and pharmacological approaches in tobacco cessation.

Step 3: selection of theory-based methods and practical strategy

Although it has been proposed that integration of intervention objectives and strategies with a behavior change theoretical framework takes place as a third step in IM [39], in reality, the theoretical framework (Social Cognitive Theory—SCT) [45] guided the entire process, including the needs/assets assessments. SCT posits that behavior change is a result of a dynamic interaction between the individual, his/her behaviors and his/her environment through reciprocal determinism (i.e. behavior changes as a result of a bidirectional interaction between the person and the environment). It consists of six constructs: behavioral capability (knowledge and skills to perform a particular behavior), observational learning, outcome expectations (anticipated outcomes), outcome expectancy (values placed on the anticipated outcomes), self-efficacy and reinforcement [46]. The theoretical framework for intervention development is conceptualized differently than the ‘strategies’ used in the intervention to promote cessation at the individual level, which were based on Cognitive-Behavioral Therapy (CBT) [40] as described above. While the SCT provides a framework for the macro-level adaptations, CBT directly addresses the micro-level components [47]. For the capacity building of the CHWs, we incorporated the Stages of Change Model because of its simplicity in tailoring behavior change strategies to the different stages that participants were in when approached by CHWs [48].

Step 4: production of program components and design

The next step consisted of development of intervention content, materials, format, unit of randomization, etc. as well as determining the comparison group. As such, in collaboration with the public health system leadership at the state level as well as network members, it was decided that it would be relevant to compare the current tobacco cessation intervention delivered through the public health system (standard of care) with an ‘enhanced’ intervention that would consist of the tobacco cessation intervention being delivered through the public health system, augmented by 12 home visits by CHWs for a period of 6 months. Therefore, the comparison group only included the invitation and scheduling for the tobacco cessation intervention offered through the public health system.

As previously indicated, the health care system already has an evidence-based tobacco cessation program that is delivered through BHUs by health care professionals who undergo a capacity building program [49]. Based on literature review and needs/asset assessments (including the support from administrators and health care professionals) [39, 50–53], we chose an intervention that would be delivered within the public health system but augmented by CHWs. Our preliminary findings have shown that they were already part of the health care system, and, although willing to get involved in the tobacco cessation program, their role was restricted to referrals and scheduling appointments [37].

CHWs are ‘natural helpers’ and trusted community members who serve as mediators between the health care system and the community [54]. They have the ability to reach individuals who have not been reached for broader efforts, and are able to ‘translate’ health information to language that lay individuals can understand. Equally important, they are a source of support to community members, given their natural empathy and ability to relate to others. Therefore, with appropriate training, they can be actively involved in the promotion of relevant healthy behaviors, including tobacco cessation [50, 53, 55]. Additionally, given the gender-relevance of our intervention and the importance of social support in the process of cessation among women, we established that CHWs must be women and not current tobacco users. The CHW capacity building program and its results are described elsewhere [56]. In summary, this intervention focused on tobacco control, tobacco cessation, behavioral modification strategies and skills, and communication and problem-solving skills.

For the intervention component, we worked with a graphic design to develop all materials, including the CHW capacity building program. Given the literacy level of the target audience, it was critical to rely on illustrations and behavioral cues to convey the key messages to participants. The capacity building of CHWs followed the same approach. Once finalized, we proceeded to pretesting.

Resnicow et al. [57] proposed a two-stage process for preliminary testing of the intervention which is built around formative assessments (describe above) and pretesting. Formative assessments usually provide the substrate for message content and precede message development and pretesting. In both phases, it is critical to pay attention to surface and deep structures. Surface structure sensitivity includes the use of appropriate language, materials, etc., at a surface level. Deep structure sensitivity further involves knowledge of cultural behavior and practices and an in-depth understanding and appreciation for cultural themes in relation to the desired behaviors.

A total of 19 participants (5 women current/former tobacco users, 4 health care professionals and 10 CHWs) participated in this phase. In order to facilitate feedback, we organized these meetings into groups of three participants within each of the segments (women, health care professionals and CHWs). In addition to the training manual for the capacity building of CHWs, they were provided with a training manual to guide the implementation/delivery of each session. The training manual included performance objectives as well as materials and a checklist to assure that the CHW addressed all components of a specific session. The participant materials were interactive and consistent with basic principles of behavior change. An effort was made to actively engage participants in the process, considering their literacy level (e.g. questions regarding reasons to smoke/reasons to quit, refrigerator magnet to indicate the quit date, home sticker ‘my house is tobacco free’). Participants received a binder during the first session, and supporting materials for each of the sessions would be added through the intervention implementation. Sessions were also color coded.

At the ‘organizational level’, we conducted a 4-hour webcast tailored to health care professionals within the public health system across the state focusing on the cognitive-behavioral and pharmacological management of nicotine dependence (n = 333). As described above, although the delivery of the tobacco cessation intervention within the public health system was the same for both arms, our needs/assets assessments indicated that the tobacco cessation program was not uniformly implemented across the state. Therefore, this workshop was an effort towards increasing capacity as part of our collaborative efforts with the public health system.

Step 5: development of an implementation plan

Once the development of the intervention was finalized, meetings with the public health system leadership at the state and municipal levels were conducted to finalize implementation details. It was decided that randomization would occur at the town level to avoid contamination. A total of eight towns had been previously identified. The municipal leadership identified the BHUs in each town that would participate in the study based on the following inclusion criteria: (1) if they provided the tobacco cessation program and (2) had a catchment area of at least 1000 households because our previous data have shown that tobacco use prevalence among adult women ranged from 10% to 19.1% across the state [35]. The leadership at each BHU identified and selected the CHWs who will participate in the study. Although only 32 CHWs were needed to participate in the intervention component of the present study, as a commitment to the health care system, we trained 80 CHWs. Our findings indicated that 85% never took specific courses aimed at tobacco dependence treatment and 86.1% never worked in the Tobacco Cessation Program at the BHU. Pre- and post-training findings indicated that the capacity building program increased CHWs’ tobacco control and behavior change knowledge as well as increased their self-perception regarding their ability and confidence to assist women in the tobacco cessation process [56].

Step 6: evaluation of process and effect

Once all the details were discussed and approved by the leadership of the public health system, we developed a detailed Standard Operations Procedure, and finalized all the process, impact and outcome evaluation. The primary outcome was 7-day abstinence at 7-month follow-up, which was verified by an objective measure of CO at undetectable rates (cut-off score of 8 ppm).

Process evaluation or treatment fidelity was addressed at five levels based on the NIH Behavior Change Consortium recommendations (study design, staff training, delivery of treatment, receipt of treatment and enactment of treatment skills) [47]. Outcome evaluation included assessments of all components of the proposed theoretical models as well as the proposed outcomes. The outcome evaluation consisted of baseline, post-intervention and 6-month follow-up assessments.

All phases of the research project were reviewed and approved by the Institutional Review Boards at participating institutions, public health system (state and municipal levels), and the Brazilian National Ethics Committee.

Results

The results of the needs assessment are summarized in Table I. Regarding the individual/interpersonal level, variables such as esthetics, family and social cues were indicated as motivators for smoking cessation. Smoking as a strategy for weight control and mood management, lack of social support, lack of assertiveness to deal with social pressure to smoke and lack of recognition of themselves as smokers (in the case of light smokers) were the most frequent barriers.

Table I.

Relevant findings of the needs/assets assessments

Level	Relevant findings
Individual/ Interpersonal	Positive/facilitators   65.6% of smokers intend to quit in the next 12 months 54.6% of current smokers tried to quit smoking in the past 12 months Esthetics, smell and social isolation are very important motivators to quit smoking Family—motivator Current and former smokers perceive that smoking leads to depression and anxiety Only 18.9% of current smokers report smoking their first cigarette within 5 minutes after waking up 91.9% indicate that smoking is not allowed in any closed spaces in their work environment and 97% indicate that the current tobacco control law is being enforced in public buildings across the state Current smokers tend to respond more to social cues than habitual cues  Negative/barriers   Some light smokers do not consider themselves smokers Lighter smokers perceive themselves to be at a lower risk for health problems than women who smoke more than 10 cig/day Weight control and stress management are great motivators to continue smoking among current smokers Pleasure and coping with stress/nervousness are the primary reasons for smoking Physical symptoms (withdraw)—motivator to smoke Cigarette as ‘best friend’ Only 52.2% of current smokers do NOT allow smoking in their homes Only 6.4% of current smokers report getting counseling in the last attempt to quit and 6.4% report using pharmacotherapy Low cost of cigarettes, easy access Lack of awareness of smoking cessation program at Basic Health Unit Lack of confidence that smoking cessation aids and programs will help women to quit smoking Lack of assertiveness when other insist that they smoke Lack of social support—contributor to relapse Embarrassment to return to the Basic Health Unit if they relapse
Community/ Organizational	Positive/facilitators   Committed health care professionals Structured capacity building program; administrators and health care professionals were satisfied with the program [36] Group sessions—ability to reach more people than individual sessions Health care professionals indicate that the program is effective if implemented by dedicated professionals Support from administrators and health care professionals on the possibility of engaging CHWs in the program [37]  Negative/barriers   Limited offering of capacity building for health care professionals Counseling sessions cannot be implemented without physicians leading the program and there is a scarcity of physicians in the public health system Health care professionals are trained but not retained in the program due to lack of support and competing demands Tobacco cessation program offered during working hours Lack of adherence among patients Although gender is acknowledged to be an important aspect to be considered in tobacco cessation, the program is gender neutral
Policy	Positive/facilitators   Mandate from the Ministry of Health to provide tobacco cessation services through the Basic Health Units National guidelines and capacity building on the use of evidence-based approaches in tobacco cessation Municipal, state and federal smoke-free environment legislation  Negative/barriers   Adherence to the tobacco cessation protocol across Basic Health Units varied drastically and lack of oversight to assure adherence to protocol by state and federal entities Counseling sessions cannot be implemented without physicians leading the program and there is a scarcity of physicians in the public health system Lack of reliable data on program effectiveness

From the community/organizational point of view, the commitment of health professionals to the cessation program, as well as the positive perception of managers and health professionals related to the involvement of CHWs in the intervention were the main aspects identified as barriers. The scarcity of physicians whose participation is mandatory in the program, the limited provision of training programs for new professionals who want to work on tobacco cessation, as well as the characteristics of the program implemented at the BHU which does not take into account the specificities of gender could also be observed. Finally, at the policy level, the most positive aspects identified were related to the mandatory provision of the cessation program in the BHUs, the existence of national guidelines and capacity building on the use of evidence-based approaches in tobacco cessation, as well as smoke-free environment legislation at municipal, state and federal levels. The main barriers were the lack of adherence to the tobacco cessation protocol across BHUs and the lack of reliable data about the effectiveness of the program.

Regarding the definition of program objectives, the first step was to break the overall goals of the program into sub-behaviors, known as performance objectives [58], based on the needs’ assessment and behavioral and environmental determinants of cessation in the target population investigated. These performance objectives played an important role in defining the intervention strategies that would be used (see Table II). The intervention strategies, planned based on the main stages of tobacco cessation, were as follows: (1) assessment/referral—to motivate participants to quit, (2) management—to develop and promote adherence to their quit plan and (3) follow-up—to prevent relapse and promote long-term abstinence.

Table II.

Proposed intervention: performance behaviors, main intervention objectives and strategies as they relate to the theoretical constructs

Theoretical constructs	Assessment/referral—to motivate participants to quit
	Performance behaviors	Main intervention objective/strategies
Behavioral capability	Recognize the importance of knowing themselves as a step for behavior change Identify resources available to promote quitting and staying tobacco-free Mention reasons for quitting smoking Identify sources of social support	Cessation is an individual process, what works for some may not work for others Importance of knowing themselves and what works for them—discovery process. Tailor knowledge and skills to participant’s readiness Promote awareness that if someone smokes on a regular basis, she is a smoker and smoking is an addiction; light smokers are smokers. Provide information on the benefits of counseling and tailored pharmacological approaches Promote knowledge on available resources to promote quitting as well as staying tobacco free, including services the public health clinics have to offer Personalize to women—gender pride, esthetics, women as role models Address their immediate needs including education about resources available in the community for problems they are currently facing (e.g. parenting, financial problems) Provide tools and skills to seek social support
Observational learning	Identify, from interactions with other women, possibilities of changing her behaviors regarding cigarette use	Provide credible role models that reflect the target population Sharing stories of other women within the state
Outcome expectations	Identify their tobacco use habits and evaluate what worked and what did not work in previous attempts. Mention reasons for quitting smoking Have a positive expectation of personal benefits in the context of a smoke-free lifestyle	Tobacco use topography/smoking patterns: motivators/disadvantages to smoke, when/where/with whom they smoke, motivators to quit, anticipated barriers to quitting, social support Demonstrate positive consequences associated w/ quitting and challenge the barriers to quit
Self-efficacy	Promote efficacy that benefits of quitting counterbalance the disadvantages Promote a positive expectation of quitting	Break down behavior change into small and measurable steps and build in goal setting activities (self-regulation) Break down the steps about scheduling an appointment at the UBS and/or first steps to move toward quitting If the participant had unsuccessful past attempts, reinforce that she is trying again and emphasize what she learned from previous attempts
Reinforcement	Decide to quit	Reinforce the decision to consider quitting

Theoretical constructs	Management—to develop and promote adherence to their quit plan
	Performance behaviors	Main intervention objective/strategies
Behavioral capability	Make a personal plan to quit Monitor her dependence Commit to the cessation attempt Make a plan to cope with withdrawal symptoms and cravings in different situations (e.g. psychological problems, physical dependence) Talk assertively to health professionals about their health needs regarding pharmacological and counseling approaches. Talk assertively to other smokers about remaining a non-smoker Identify reasons why it is important to have smoke-free homes and how to avoid smoking exposure at work and in social settings Talk assertively to others to have support for a tobacco-free home Seek social support when needed Identify relapse as part of the smoking cessation process	Develop and promote adherence to their quit plan Promote skills on how to cope with depression and anxiety Promote knowledge and skills in anticipation for withdrawal symptoms and cravings Promote stress management skills and identify other pleasurable activities Individualized plan to quit—assist the participant to determine a personal course of action Reinforce tobacco industry manipulating strategies to promote addiction Promote doctor-patient communication skills to address their specific needs regarding pharmacological and counseling approaches Provide tools and skills for having smoke-free homes and how to avoid smoking exposure at work and in social settings, including assertiveness skills for tobacco-free homes Reinforce importance of reliance on each other in the cessation group and/or others for support Assurance that relapse is not failure
Observational learning	Identify stories of people they know who have been able to quit as well as people who have not been able to quit Identify positive changes they have observed in themselves	Who do they know? Successful and not so successful stories of smokers Discuss positive changes that they have observed in themselves
Outcome expectations	Have a positive expectation of addressing successfully potential barriers to remain a non-smoker Identify alternatives to dealing with unwanted effects of cessation such as weight gain	Personalize the pros and cons of quitting (cognitive restructuring) Assist with healthy eating and physical activity to prevent weight gain Reinforce the knowledge on the physical esthetics effects and negative social/professional image of smoking in the context of positive consequences of quitting Discuss perceived advantages/disadvantages of quitting and how to maximize the advantages and cope with the disadvantages
Self-efficacy	Express a belief in her ability to take control of her health Recognize small successes towards her goal Express a belief in her ability to ask for assistance	Empower participant to take control of her health Acknowledge success Promote skills on how to ask for assistance from the group, provider, family/friends, and/or CHW Identify and address specific situations in which participant may have low self-confidence
Reinforcement	Socialize with non-smokers Do things that are incompatible with smoking and that are reinforcing	Reinforce opportunities to socialize with non-smokers (↓ perceived ‘ostracism’) Reinforce perceived behavioral control over their health

Theoretical constructs	Follow-up—to prevent relapse and promote long-term abstinence
	Performance behaviors	Main intervention objective/strategies
Behavioral capability	Develop coping strategies Talk assertively to others about remaining a non-smoker Evaluate and adjust strategies to prevent relapse In case of relapse, identify strategies to overcome embarrassment and seek help	Prevent relapse and promote long-term abstinence How to cope with cravings and withdrawal symptoms Promote skills on how to cope with depression and anxiety Promote stress management skills Assist participant to continue with goal setting. Continue cognitive restructuring based on the list of pros and cons Facilitate continued access to needed resources Seek assistance from provider immediately when experiencing a relapse; how to overcome embarrassment Facilitate access to health care professionals to prevent relapse Reinforce learned strategies on how to remain a non-smoker around smokers Reinforce cultural norms to be non-smokers Identify specific areas of difficulties and strengths when dealing with social pressure Promote refusal and assertiveness skills in dealing with pressure from friends
Observational learning	Participate in a support group with other women in the neighborhood who are going through the cessation process	With permission from participants, identify other women in the neighborhood who are going through the process and organize for them to get together as a support group
Outcome expectations	Have a positive expectation of addressing relapse prevention issues Have a positive expectation of the positive short- and long-term consequences of quitting	Continue to demonstrate the positive short- and long-term consequences of quitting Revisit the pros and generated by the participant—Continue cognitive restructuring based on the list of pros and cons Problem solving to prevent relapse
Self-efficacy	Express a belief in her ability to prevent future relapses Express a belief in her ability to maintain abstinence	Promote skills, self-responsibility and personal control regarding relapse prevention as well as encourage seeking support from others or the CHW Acknowledge success Identify and address specific situations in which participant may have low self-confidence
Reinforcement	Talk assertively to people about remaining abstinent Talk assertively to people about her smoke-free home	Continue positive reinforcement of abstinence particularly when reports of others experiencing tobacco-related disease are discussed Positive reinforcement of successful attempts (e.g. refusal skills)

In general, the main sub-behaviors regarding the first stage of tobacco cessation were related to enabling women to identify motivators and resources available for cessation, as well as assessing their tobacco use patterns and having a positive expectation to live a tobacco free life. In the second stage, the primary focus was planning for cessation and dealing with slips and possible relapses, identifying alternatives to remain abstinent, seeking social support when necessary, and talking assertively in different contexts according to their needs. In addition, for the third stage, we focused on having positive expectations, self-efficacy in preventing relapses and strategies to remain abstinent.

Based on the results obtained in the program's needs assessment and goal setting stages, and considering that the BHUs were already implementing an intervention program to promote cessation, we proposed an ‘enhanced’ intervention that would consist of 12 home visits to be undertaken by CHWs over six months. The content and timing of these visits are described in Table III and are also based on the main tobacco cessation stages: motivate participants to quit (visit 1), develop and promote adherence to their quit plan (visits 2–4) and prevent relapse and promote long-term abstinence from a gender-relevant perspective (visits 5–12).

Table III.

Content of the CHW visits

Visit	Content	Timeline
1	Motivating participant to quit Benefits of quitting Nicotine dependence ‘Normalize’ with data from other women smokers in the state Reasons to quit/reasons not to quit Tobacco cessation is a process Diary of tobacco use What to expect from the tobacco cessation program at the Basic Health Unit* Benefits/difficulties of quitting Social support	After consenting and completion of baseline assessments and before the first tobacco cessation session at the Basic Health Unit*
2	Deciding on how to quit, anticipating challenges and coping strategies	After the first tobacco cessation session at the Basic Health Unit*
3	How to deal with physical and psychological cravings	Between the 3rd and 4th tobacco sessions at the Basic Health Unit*
4	Revisiting the reasons to quit and advantages of staying abstinent	One week after the 4th tobacco cessation session at the Basic Health Unit*
5	How to cope with slips and relapses	15 days after visit 4
6	How to prevent or deal with potential weight gain	15 days after visit 5
7	How to keep their families protected from environmental tobacco exposure	15 days after visit 6
8	How to stay abstinent without medication and/or NRT	15 days after visit 7
9	How to deal with social pressure	15 days after visit 8
10	Benefits of a tobacco free lifestyle	One month after visit 9
11	Industry manipulation strategies	One month after visit 10
12	Focus on a tobacco free healthy lifestyle (e.g. healthy eating, physical activity, stress management)	One month after visit 11

Regarding the evaluation of the intervention, detailed process evaluation strategies were implemented in all phases of intervention development and implementation, which is consistent with our previous efforts [59–61]: (1) ‘Needs/Assets Assessments and Pretesting’—the primary goal of these activities was to truly listen to focus group/interview participants. As such, the process evaluation focused on whether this activity follows the proposed methodology (e.g. review of transcripts from discussions/focus groups) and whether the intervention development was participatory; (2) ‘Capacity Building/Health Care Professionals’—we documented whether the suggestions obtained in the needs/assets assessments were incorporated. We also kept track of how it was advertised, the number of registered participants, the number of attending participants, their demographic profile, etc.; (3) ‘CHW Training’—Consistent with the capacity building of health care professionals, we documented whether the training incorporated suggestions obtained in the need/assets assessments, assessed the impact of the capacity building through pre- and post-intervention and obtained CHW feedback on format, content, etc.; (4) ‘Intervention’—Process evaluation or treatment fidelity were addressed at five levels based on the NIH Behavior Change Consortium recommendations and suggested strategies (as shown in Table IV).

Table IV.

Treatment fidelity strategies

Level	Goals	Strategies
Study design	Ensure same treatment dose within conditions Ensure equivalent dose across conditions	CHWs completed a ‘visit evaluation’ form for each encounter with the participant—we have used this form in previous studies to document the length of the encounter, difficulties, etc. CHWs kept a contact log for each participant (including phone calls initiated by participants)
Staff training	Standardize training Ensure CHW skills acquisition Minimize ‘drift’ in CHW skills Accommodate CHW differences	Capacity building followed a structured manual In order to minimize ‘drifts’ and accommodate CHW differences, we conducted booster sessions and monthly meetings with CHWs as well as in vivo observations of data collection and intervention/control sessions with a provision of providing feedback using a ‘quality assurance’ form that we have used in previous studies. In addition, CHWs were constantly supervised by the program manager
Delivery of treatment	Monitor and control for participant perceptions of nonspecific treatment effects (e.g. perceived warmth, credibility, etc.) Ensure adherence to intervention and control conditions protocol Minimize contamination across conditions	Provision of manualized protocol and sporadic observation as described above Revision of CHW logs and ‘encounter evaluation forms’ Use of different CHWs to provide the intervention and control Assessment data were collected by data collectors and NOT the CHWs
Receipt of treatment	Ensure that participants understand the information provided Ensure that participants are able to use the skills taught (cognitive/behavioral)	Program manager sporadically administered simple pre- and post-test interviews to participants that pertain directly to the techniques, information, and philosophies discussed in the intervention encounters in order to determine whether the intervention has been received. The PI/Program Manager will also randomly select some participants and provide them with hypothetical situations and ask them to provide strategies for dealing with these situations Post-test, and 6-month F/U asked information on receipt of treatment
Enactment of treatment skills	Ensure that participants use the skills taught	During the pre- and post-test interviews described above, Program Manager asked participants whether they have used (and how they have used) the skills learned in the intervention Post-test, 6-month F/U asked information on enactment of treatment skills

Discussion

We have used the methodology of IM to describe the development of a theory-based, culturally and gender-relevant CHW-led tobacco cessation intervention for low-income Brazilian women that augments the tobacco cessation program offered through the public health system. Through IM, we were able to establish a logical planning process that was guided by a theoretical framework (SCT), based on previous tobacco cessation evidence-based programs, and implemented within the social and political context of a universal health care system in a middle-income country. The impetus for such a detailed description of the process using IM was our own struggles when conceptualizing the study and all steps involved given the scarce literature on the development of tobacco cessation programs, particularly in low-resource settings and considering sustainability since its inception. While having evidence-based programs is very important, a number of organizations in low-resource settings are unable to adopt them for a number of reasons, including feasibility because these interventions do not consider the multi-level context in which the program takes place when efficacy is being established [62].

The first and foremost identified gap was the need for a tobacco cessation program that met the specific needs and wants of women. As such, the entire process was implemented through the gender integration approach. ‘Gender integration in health is the process of creating the knowledge and awareness of–and responsibility for–addressing gender in health systems and programs. Gender integrated approaches treat women and men’s relative social, political, economic, educational, and health status as interrelated, intersectional, interdependent, and changeable. Consequently, to be successful, gender-focused health programs often have to be multi-sectoral and engage a wide variety of male and female stakeholders, regardless of whether the focus of the program is on women, children, or men’s health’ [63]. Hence, the focus of the needs/assets assessments at multiple levels (individual, community, organizational, and policy) through primary and secondary sources and with engagement of all involved stakeholders in the process, which can be challenging if a methodic and systematic approach is not used. The first phase (needs/assets assessments) provided us with the foundation to understand the specific needs and wants of each stakeholder (e.g. women, CHWs, health care providers, administrators), but, most importantly, the role of gender and associated inequities, gaps, and disparities within this particular context and culture, as well as insights on the limitations and opportunities [63].

For instance, when examining the current tobacco cessation program offered through the public health system, we identified a major gap between the guidelines and actual implementation. Regarding gender, although health care providers recognized that patterns of tobacco use and cessation are different among men and women, none of the strategies was tailored to meet the specific needs of women or men and the program was being implemented through the ‘one size fits all’ approach.

The present study has some limitations worth mentioning. First, this study was done in the context of a universal health care system where tobacco cessation is offered through the BHUs at no charge to residents. However, despite being offered free of charge utilization is low. Therefore, augmentation of these services taking into account gender represented a promising strategy. Second, although we conducted an extensive needs/assets assessment of the tobacco cessation services offered through the public health system, there was no reliable data on cessation rates among men and women who participated in this program. Hence, the inclusion of a control group that consisted of provision of standard-of-care.

Despite these limitations, one of major advantages of utilizing IM in intervention development was that decisions were made in a transparent and supportive manner, which were discussed with the health care system leadership to justify the need of a gender-relevant approach. Although during the intervention development phase future efficacy or effectiveness could not assured, all involved had an opportunity to provide input and engage in a participatory decision-making process. It also provided insights on why some similar strategies may be effective and others are not [1]. On one hand this process can be very taxing on the research team and health care system as it takes time, resources and negotiation skills without sacrificing the rigorousness of the research. However, on the other hand, it builds trust and promotes ownership, which, in turn, can assure sustainability (or at least intention to adopt the program if successful). For example, one of the commitments made by the research team was that if the intervention worked, the research team would engage in capacity building of health care providers and CHWs in the towns assigned to the control group. In summary, the use of IM is a promising approach not only to systematically develop an intervention, but also to promote engagement of all involved in the process.