Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector
Phase: PHASE4
Conditions: Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking
Sponsor: University of Miami

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Principal 
Investigator
Taghrid Asfar, MD, MSPH
University of Miami Department of Public Health Sciences
1120 NW 14 St
Miami, FL 33136
(305) 243-3826
IRB Number 
(eProst ID):
20230549
Protocol Title: Expanding the role of the safety manager to implement a workplace 
smoking cessation program in the construction sector.
Funding Agency
 
Florida Department of Health 
James and Esther King
NCT # NCT06098144
Version # 7
Version Date: June 1st, 2025
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1) Protocol Title
Expanding the role of the safety manager to implement a workplace smoking cessation 
program in the construction sector.
2) Objective*
The main objective of this study is to identify the optimal adaptive smoking cessation 
program for the construction sector in terms of effectiveness, cost-effectiveness, and 
potential implementation. 
3) Background*
Tobacco use among US construction workers (CWs) is a major health disparity affecting 
minority groups. The smoking rate among CWs is double that of the general population, 
and almost half of CWs are racial/ethnic minorities, with low income and limited access 
to smoking cessation services. While implementing workplace smoking cessation 
programs among CWs has been recognized as a top priority, no systematic development 
and implementation of such programs have been attempted. Only 3 prior trials tested 
smoking cessation programs among US CWs, and all were single-level studies 
exclusively focused on individuals (CWs), without consideration of factors that might 
influence program adoption at the organizational level. In addition, an important gap in 
current knowledge is the lack of evidence about the optimal intensity for effective/cost-
effective smoking cessation programs to be implemented in the construction sector. 
Supported by an NIH/NCI grant (R21CA202993), we recently developed and pilot-tested 
a highly scalable workplace smoking cessation program that addresses the organizational 
structure, work environment, and CWs’ individual factors. For further development and 
implementation, leaders in the construction sector recommended testing 3 programs with 
increasing intensity to identify the optimal adaptive program for implementation in the 
construction sector: A) Tobacco Quitline (TQL); B) (our brief program) TQL + nicotine 
replacement therapy (NRT) + 1 group behavioral counseling session; and C) (high-
intensity program) NRT + 4 group behavioral counseling sessions; with all 3 delivered 
onsite by the safety manager. In response, we propose to test the 3 programs proposed by 
company leaders to identify the optimal adaptive program in terms of effectiveness, cost-
effectiveness, and potential implementation. Findings will inform practice and policy to 
eliminate tobacco-related health disparities among CWs by implementing sustainable 
smoking cessation services in the construction sector.
In summary, this study is significant because it will: 1) focus on CWs who are 
disproportionately impacted by tobacco-related illnesses; 2) address a critical scientific 
gap in research on workplace smoking cessation programs among CWs who are 
traditionally under-represented; 3) involve collaboration with leaders and safety 
managers in the construction sector to ensure impact, feasibility and sustainability of the 
proposed work; 4) involve the development of MLIs tailored to the construction sector 
organizational structure and CWs; and 5) generate practical, real-world evidence on the 
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optimal adaptive smoking cessation program in terms of effectiveness, cost-effectiveness, 
and potential implementation in the construction. 
4) Inclusion*
Company Leaders who are eligible for inclusion are those who are:
1) ≥18 years old
2) Involved in decision-making 
3) Willing to participate in the implementation development and evaluation 
Safety managers who are eligible for inclusion are those who are: 
1) Self-identified as a safety manager or superintendent
2) Have no plans to leave the company in the next year
3) Speak either English or Spanish
4) Non-cigarette smoker
5) Willing to receive training in smoking cessation treatment 
6) Willing to deliver the smoking cessation treatment to workers
The inclusion criteria for CWs in the intervention are:
1) ≥18 years old
2) Being a construction worker in the participating construction companies
3) Have smoked an average of ≥5 cigarettes/day in the past year (those who 
use other tobacco products such as smokeless tobacco or e-cigarettes will 
be included in the study for generalizability. However, their use will be 
monitored during the study, and participants will be encouraged to quit all 
tobacco methods).
4) Willing to make a serious quit attempt in the next 30 days
5) Willing to receive treatment from the Florida Tobacco Quitline
6) Have no plans to leave the company in the next 6 months
7) Own a telephone and plan to keep it active for the next 12 months
The inclusion criteria for CWs participating in the tobacco use pre-implementation 
assessment are:
1) Age ≥18 years old
2) Being a construction worker in the participating construction companies
5) Procedures Involved*
Study 1. Developing and testing the program implementation strategies
We will (1) develop multilevel implementation strategies (MLIs) for workplace smoking 
cessation programs delivered by the safety managers, and (2) conduct three pre-, mid-, 
and post-implementation process evaluations to examine the feasibility of the program 
implementation.
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(1) develop MLIs 
Keeping in mind that our implementation strategies will not be finalized until completing 
the pre-implementation assessment, we present below tentative implementation strategies 
based on our consultation with leaders and safety managers who agreed to participate in 
the study:
a.
Build a coalition to develop an inner support system (internal facilitation): An 
“Advisory Committee” will be formed by each construction company to guide the 
development and documentation of the program implementation within their work 
environment. Each committee will include 1) a study “champion” who will play a 
liaison role between the company and the research staff and facilitate and oversee all 
on-site implementation activities, 2) a representative for safety managers who will 
deliver the program, and 3) a representative for CWs. 
b. Provide external facilitation: The study PI (Asfar), two Co-Is (Lee and Salloum), two 
Research Assistants (RAs), and one graduate student with backgrounds in public 
health will: 1) provide ongoing consultation on program training and delivery, help 
problem solve, and offer ongoing technical support for developing and implementing 
tools for data collection, quality monitoring, and training throughout the program 
implementation process; 2) track all facilitation activities, report on implementation 
status and progress, and complete the implementation evaluation; and 3) have a 
bimonthly videoconference with the company’s advisory committees throughout the 
project to discuss progress and improvement in implementation and give input on 
study procedures, outcome assessments, and study dissemination.
c.
Assess for readiness and identify barriers and facilitators: The research team will 
conduct a pre-implementation assessment meeting with opinion leaders, safety 
managers, and representatives of CWs to present the scientific evidence behind the 
program and its benefits to the organization. The meeting will also include a 
discussion on how the program should best be implemented to fit the organizational 
context and work environment and the expected barriers and facilitators. 
d. Perform an observational field assessment of workflow on construction sites: We will 
shadow safety managers and conduct informal interviews to identify implementation 
barriers and facilitators. The assessment will provide perspective on the needs and 
assets of the existing workflow to minimize disruption and enhance program delivery 
and integrity. 
e.
Develop an implementation activities checklist: We will create an implementation 
activities checklist based on our pre-assessment that will guide the implementation 
process. We will meet with each company’s Advisory Committee to review and 
revise the activities checklist based on their local needs. We will attempt to adapt the 
planned activities for each company while retaining the core elements. 
f.
Training safety managers to deliver the program: Safety managers who agree to 
participate in the study will undergo one day of training by Asfar in: 1) study 
protocol, 2) human subjects protection, 3) clinical documentation using REDCap (a 
cloud-based web survey tool provided for free by UM) downloaded on iPads to report 
and track their activities during the program implementation, 4) program fidelity, and 
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5) practical experience in program delivery through a series of standardized 
participant encounters that involve providing the program via study protocol to an 
actor trained to portray a worker enrolled in the study. All encounters will be 
audiotaped and reviewed by Asfar and Lee to determine if safety managers have met 
the training objectives. Safety managers also will complete a 10-hour self-paced 
tobacco treatment online via the Florida Area Health Education Centers Network 
(AHEC) Cessation Program. This online program provides online tobacco cessation 
educational modules to deliver effective evidence-based tobacco use treatment and 
cessation services. 
g. Develop and organize quality monitoring system: To ensure the quality of execution, 
we will track and document all implementation activities in a time motion tracking 
log to assess the fidelity and intensity (quality and depth) of implementation [119], 
timeliness of task completion, and degree of engagement of key involved individuals 
(e.g., leaders, champion, safety managers) throughout the process. 
(2) conduct three pre-, mid-, and post-implementation process evaluations:
We will conduct three mixed-methods quantitative and qualitative process evaluations 
(pre-, mid-, post-implementation) to help improve the program implementation strategies, 
formulate interpretations of primary outcomes data (e.g., cessation rate), and create 
recommendations for future implementation. Each evaluation will be conducted among 
company leaders (n = 12-18), safety managers (n = 20-25), and CWs (n = 36, from the 
SMART study), and will include 1) key-informant interviews (safety managers, leaders), 
2) surveys (leaders, safety managers, workers), and 3) a qualitative assessment of 
documented notes and discussions from the bimonthly meetings of the investigators and 
advisory committee. In addition, we will conduct a baseline assessment of tobacco use 
among all workers in the participating companies to be able to examine the program 
reach (reach = the number of all smokers/number of smokers enrolled in the study). 
a.
In-depth key-informant interviews: As part of the implementation process evaluation, 
we will conduct semi-structured interviews that last ≈ 20-30 minutes 3 times (pre-
implementation, mid-implementation, and post-implementation) with company leaders 
(n = 12-18), safety manager (n = 20-25). Informed by CFIR, the interview guide will 
focus on perceptions regarding evidence, inner/outer context, and barriers and 
facilitators of implementation, including: 1) a short series of closed-ended questions 
(e.g., demographics, job-characteristics), and 2) open-ended questions to explore 
perceptions of program marketing, sustainability, barriers and facilitators to 
implementation, suggestions for improvement, and goals and expectations for the 
current study. Interviews will be audio-recorded and professionally transcribed for 
analysis. Data will be entered in NVivo version 12. Data analysis will include a hybrid 
inductive-deductive approach, with deductive codes informed by the CFIR’s five 
domains and inductive codes derived from emerging themes. Collaborative coding, 
data reduction, display, and interpretation will be conducted by Asfar in consultation 
with Dr. Salloum using Creswell’s 7-step analysis framework. Overlapping themes will 
be given greater emphasis. All initial codes and categories will be sorted and compared 
until core categories of recurrent themes emerge. Findings will be presented to the 
Advisory Committee during meetings to inform implementation efforts. A similar 
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analysis will be conducted on the documented notes and discussions from these 
meetings to assess the advisory committee’s performance during the study.
b. Surveys: We will conduct surveys administered through REDCap among leaders (n ≈ 
12 - 18), safety managers (n ≈ 20 - 25), and CWs (n ≈ 36; randomly selected from 
SMART). Assessments will measure: 1) evidence supporting the program; 2) 
implementation feasibility (utility/suitability for everyday use, TQL enrollment rates); 
[3) implementation acceptability including CWs satisfaction with the program (using 
the Client Satisfaction Questionnaire), safety managers’ training and incentives, 
comfort, and delivery; 4) barriers to program implementation; 5) changes in 
implementation self-efficacy and behavior capabilities; and 6) the Organizational 
Readiness to Change Assessment (ORCA). To assess program adoption, we will 
conduct a monthly assessment of 1) the proportion of CWs who are screened, 
enrolled, and engaged in the treatment, and 2) the proportion of safety managers who 
are providing the treatment. We will assess the programs’ short-term (3-month) 
sustainability at the individual and setting levels. At the individual level, we will 
examine monthly enrollment rates to examine time trends in enrollment and whether 
CWs and safety managers continue to use the program during the 3 months after 
completing the study. At the setting level, we will use the Intervention Sustainability 
Assessment Tool (PSAT) to assess each program’s current capacity for sustainability 
across a range of specific organizational and contextual factors (e.g., capacity, 
environmental support). Numbers (%) will be used to present data from categorical 
variables in the surveys. Continuous data will be presented as means [+/-SD].
In addition, we will conduct a tobacco use assessment among all workers in the 
participating companies to be able to examine the program's reach. To do so, we 
added a new consent form and a brief survey instrument for the assessment.
Study 2. Cluster, hybrid type 1 effectiveness-implementation, 2-phase SMART Clinical 
Trial
We will conduct a pragmatic, 2-arm, cluster, hybrid type 1 effectiveness-implementation, 
2-phase SMART to test the 3 programs proposed by leaders: A) TQL; B) TQL + NRT + 
1 brief group behavioral counseling session; and C) NRT + 4 intensive group behavioral 
counseling sessions. We removed the NRT from group A because the Florida TQLs 
provide up to 12 weeks of NRT.
We will recruit 32 construction sites within 8 construction companies with 608 CWs who 
are smokers. In Phase 1, construction sites will be randomly assigned to two conditions in 
a 1:1 ratio (A or B; 16 sites/group). Study participants (n=608; 304/arm) working in these 
companies will receive treatment delivered by the safety managers following the regular 
daily safety briefings. In Phase 2, responders (CWs who quit smoking at the 1-month 
assessment based on self-reported abstinence (defined as not smoking even, a puff, after 
15 days of quitting date until now)validated by saliva cotinine tests) will continue in the 
same treatment (conditions A1 & B1). Non-responders (did not quit smoking at 1-month 
assessment) will be re-randomized either to C (conditions A1+C & B1+C) or to the same 
treatment (conditions A2 & B2) in a 1:1 ratio adjusted depending on the rate of non-
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response in Phase 1. Randomization in Phase 1 will be stratified by company instead of 
sites, to avoid cross over contamination by workers who may be working at multiple sites 
simultaneously. Worker-level randomization in Phase 2 will be stratified by company and 
by the treatment groups in Phase 1 of SMART. In Phase 1, participants in A1 and B1 will 
receive a 1-month follow-up to determine they quit smoking. In Phase 2, all participants 
will receive 3 follow-up assessments at 6, 9, and 12 months after enrollment. These 
follow-up assessments will assess smoking status (using the timeline follow-back 
measure [145]), use of additional NRT or cessation drugs (e.g., bupropion), use of other 
tobacco products, and number/time of contact with the safety manager and TQL. 
Biochemical validation of smoking status via salivary sample for cotinine analysis will be 
obtained from those who self-report quitting cigarettes (not smoking, even a puff, after 15 
days of quit date until now) at the 1-month and 12-month assessment. Saliva samples will 
be collected using the NicoTests® Cotinine Test Device for the detection of Cotinine, a 
metabolite of nicotine. This test detects Cotinine in oral fluid/saliva at cut-off 
concentrations of 30 ng/mL, the standard US level for oral fluid nicotine/cotinine tests. 
Saliva concentrations of Cotinine reflect blood levels. 
In the SMART study, participating CWs will receive a total of $100 incentives ($20x5 
assessments). Safety managers will receive a $500 gift card for participating in the study. 
In the implementation process evaluation, CWs who complete the tobacco use assessment 
survey will receive $10. In addition, CWs (n ≈ 36; randomly selected from SMART) and 
safety managers (n ≈ 20) will receive an additional $120 for completing 3 surveys ($20 
each) and 3 interviews ($20 each). Participating leaders (n ≈ 12) in the key informant 
interviews and the surveys will receive UM memorabilia (t-shirt, cup, bag). 
Nicotine Replacement Treatment
Given the highly active nature of CWs job, excessive sweating might affect the 
stability of the nicotine patches. Therefore, we will use the Nicorette™ gums (2 mg, 4 
mg) to help stop smoking. We will determine the initial dose based on self-reported 
cigarette consumption (see Table 1). NRT will be distributed in Phases 1 and 2 based on 
the treatment condition. In Phase 1, participants in Group B will receive 3 weeks of NRT 
treatment in session 1 after the referral to the FL TQLs, and another 3 weeks at the 
second follow-up (2 weeks after the quit date). In Phase 2, participants in B2 will receive 
3 weeks of NRT treatment in Session 1 and another 3 weeks at the second follow-up (2 
weeks after the quit date). Participants in Group C will receive 3 weeks of treatment in 
Session 1 and another 3 weeks of treatment in Session 4. All participants will receive 
detailed instructions regarding proper gum use and side effects. We will monitor 
concomitant smoking during NRT use and the use of additional NRT or other cessation 
drugs (e.g., bupropion).  
Table 1. Nicotine gum dose based on the number of cigarettes smoked per day 
Number cigarettes 
smoking
Starting dose of 
Nicotine Gum
Dosing Schedule
Maximum pieces per 
day
Greater than 20 
cigarettes/day
4mg
4 mg every 1-2 hours 
Max 8 pieces a day
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Less than 20 
cigarettes/day
2mg
2 mg every 1-2 hours 
Max 8 pieces a day
Nicotine Gum Use.
•
Never smoke and use nicotine gum at the same time
•
Use gum only when you have a craving for a cigarette
•
Do NOT treat it like chewing gum.  It is not to be constantly chewed
•
Chew approximately 10-15 times until you get a peppery or tingling feel in your 
mouth, and then “park” the gum between the cheek and gum on one side of the 
mouth or the other
•
Once the tingling/peppery taste disappears, chew another 10-15 times until the 
sensation returns, and then park the gum on the other side of the mouth
•
Repeat for up to 30 minutes
•
It may be irritating to the inside of your mouth, so move it from spot to spot when 
you park it; and 
•
Avoid acidic beverages (e.g., coffee, juice, soft drinks) for at least 15 minutes 
prior to using gum.
Nicotine Gum Side Effects.
Although most persons do not experience any major side effects from nicotine gum, it is 
possible that a participant could experience any of the following side effects. All 
participants will be questioned or evaluated for these specific side effects at each session 
after the gum is dispensed.
•
Mouth soreness. Very rare. The probability of occurrence is low, and the risk is 
low.
•
Hiccups. This typically occurs through improper use of the gum.  If participants 
report this, we work on how they are using the gum.  Probability is common in 
those who misuse the gum; risk is low
•
Dyspepsia. The probability and risk are low.
•
Jaw ache. The probability and risk are low.
Management of Adverse Events Potentially Related to the Study Medication.
If you are experiencing any major side effects, please call us at this phone number: (305) 
243-0362 or (786) 505-2920.
Study’s Assessments:
1. Baseline Assessment. Eligible CWs participants will undergo a 15-20 min Baseline 
Assessment after consent is given. The baseline assessment will collect information about 
demographics (age, race/ethnicity, sex, education, marital status), job characteristics, 
work-related injuries, acculturation, the General Ethnic Discrimination Scale, job stress, 
ASSIST for alcohol and substance use assessment, social support, and quality-of-life 
(EQ-5D-3L). Tobacco smoking history and dependence will be assessed using the 
Fagerström Test for Nicotine Dependence, with additional items assessing the use of e-
cigarettes and other tobacco products, exposure to secondhand smoke, salivary cotinine 
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and exhaled carbon monoxide. Depressive symptom assessments include the Perceived 
Stress Scale and Center for Epidemiological Studies Depression Scale-10 (CES-D). 
Saliva samples will be collected using the NicoTests®.This test detects Cotinine in oral 
fluid/saliva at cut-off concentrations of 30 ng/mL (< 30 indicates abstinence). Carbon 
monoxide breath test results will be collected using a CO Check Pro carbon monoxide 
breath monitor from Medical Device Depot, with an expired carbon monoxide (CO) level 
cutoff of <6 ppm.
2. One-month assessment (Group A1, B1). At the end of Phase 1, all participants in 
Groups A1 and B1 will receive a 1-month assessment to collect information about their 
enrollment in the FL TQL, the number/time of total contact with TQL, and their smoking 
status to determine if they quit smoking. Biochemical validation of smoking status via 
salivary sample for cotinine analysis will be obtained from those who self-report quitting 
cigarettes. Saliva samples will be collected using the NicoTests®.This test detects 
Cotinine in oral fluid/saliva at cut-off concentrations of 30 ng/mL (< 30 indicates 
abstinence). Participants who do not answer 10 attempts to be contacted for their 1-month 
follow-up will be marked as “lost to follow-up”.
3. Intra-treatment (Group C). In Phase 2, participants in Group C will complete an 
assessment at sessions 3 and 4, including depressive symptoms, the Minnesota 
Withdrawal Scale, and the Questionnaire of Smoking Urges-Brief Scale. Participants will 
also record the number of cigarettes/day and nicotine Gums used since the previous 
session using timeline follow-back calendars. 
4. End-of-treatment (Group C). In Phase 2, at 8 weeks after the quit date, participants in 
Group C will complete an end-of-treatment assessment, including smoking status, the 
number/time of total contact with the safety manager, perceived stress, depressive 
symptoms, nicotine withdrawal, other tobacco use products, and the Group Climate 
Questionnaire. Biochemical validation of smoking status via salivary sample collected 
using the NicoTests®.This test detects Cotinine in oral fluid/saliva at cut-off 
concentrations of 30 ng/mL (< 30 indicates abstinence)
5. Six-, nine-, and twelve-month assessment  (All Groups). All participants (those who 
quit smoking in Phase 1, and those who were included in Phase 2) will receive 3 follow-
ups at 6-, 9-, and 12-months after enrollment to assess smoking status (using the time-line 
follow-back measure), concomitant smoking and NRT use, use of other cessation drugs, 
use of other tobacco products (e.g., e-cigarettes), number/time of total contact with 
interventionist and TQL, depressive symptoms, the Minnesota Withdrawal Scale, and the 
Smoking Urges-Brief Scale. The smoking status of those who reported  quitting smoking 
at 12 months will be verified using the NicoTests®. This test detects cotinine in oral 
fluid/saliva at cut-off concentrations of 30 ng/mL (< 30 indicates abstinence).  This will 
be done in-person or remotely  via a HIPAA authorized Zoom meeting.the  
Intervention:
This study will test 3 programs:  
Group A1 and A2: CWs in this group will be referred to the TQL by the research team 
using the “Automated online referral form.” Participants will be informed that the TQL is 
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free, and the TQL counselor will provide three phone counseling sessions to devise a 
specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on 
need. Participants will be advised to request nicotine gums instead of patches to 
accommodate their job circumstances (excessive heat).
Group B1 and B2: In addition to A1 and A2, CWs in B1 and B2 will receive 6 weeks of 
NRT, a brief (15-20 min) in-person behavioral group counseling session and two brief 
follow-ups (in-person or by phone) (Table 4). The behavioral counseling session has been 
developed based on the SCT, our formative data, and cessation literature. The session 
will discuss preparing to quit, coping with job-related stress, getting social support, the “5 
A’s” for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), and 
proper use of NRT. The first follow-up will occur 1 day before the quit date to remind 
participants about their quit date and provide support. The second follow-up will occur 2 
weeks after the quit date to discuss progress and skills to prevent relapse and help 
reengage the participant in another quit attempt if they have lapsed. In our pilot trial, the 
two follow-ups were provided by phone. However, given the daily contact between the 
safety managers and CWs, we believe that a brief in-person check would be more 
effective and generalizable than the phone for this target population. It will also provide 
more support to smokers and help change the social norm about smoking within the 
organization.  
Group C: Participants who did not quit smoking at the 1-month follow-up after the first 
randomization (in Phase 1) will be re-randomized either to C or to continue in the same 
treatment (A 2 and B2, See study design section). Participants in group C will receive a 
6-week free supply of NRT, 4 (20-min) group behavioral counseling sessions, and two 
brief follow-ups (in-person or by phone) (Table 5). Session 1 (2 weeks before the quit 
date) discusses reasons to quit, preparing to quit, coping with negative affect and job 
stress, and the “5 A’s”. Session 2 (on the quit date) focuses on short-term relapse 
prevention training, surviving the first few days as a nonsmoker, challenges in previous 
quit attempts, and managing nicotine withdrawal. In session 3 (2 weeks after the quit 
date), we determine if participants quit (if not, we process reasons and reset the quit date) 
and review motivating images. Session 4 (4 weeks after the quit date) focuses on long-
term relapse (4 rules for limiting access to cigarettes, personalized relapse plan), and 
negative thoughts. Gums use and problem-solving of any adherence or side effect issues 
will be discussed in every session. In the first follow-up (6 weeks after the quit date) and 
second follow-up (8 weeks after the quit date), we will discuss progress and skills to 
prevent relapse and help reengage another quit attempt if they have lapsed.  
All participants will receive educational information about (1) the extra risks of smoking 
on CWs, given their exposure to occupational hazards (e.g., injuries, and exposure to 
toxins), and (2) the need to consider quitting all tobacco products. Participants will be 
given self-help materials in their preferred language summarizing their program content.
The Intervention Fidelity
To ensure standardization of program content and delivery, we will use standardized 
training and treatment manuals/procedures. Safety managers will complete a checklist at 
the end of each session to document whether treatment components were delivered or not 
(we added the checklists for each program with our modifications). Participants will 
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respond to a brief questionnaire at the 1-month follow-up in Phase 1 and 12-month 
follow-up in Phase 2 to assess whether key points were learned, including the techniques 
and information discussed in the counseling sessions. All participants will be asked about 
the number and content of contacts with TQL. Additionally, we will audiotape a random 
sample of 10% of counseling sessions for review and feedback. We will also develop a 
structured intervention fidelity checklist to guide the interventionists and ensure 
compliance with the intervention. Participants will be asked for permission to audiotape 
these sessions as part of the consent process. 
6) Data and Specimen Banking*
N/A
7) Data Management*
Data from the baseline assessment and survey will be collected and stored in REDCap 
and accessed only by approved study personnel. 
8) Risks to Subjects*
The main risks to CWs’ and safety managers’ participation in the study are the time taken 
away from their work schedule and the discomfort they may feel in answering some 
questions about their work environment, role in the company, and other areas related to 
their job. To avoid coercion of CWs’ and safety managers’ participation in the study, we 
have obtained a commitment from company leaders that their participation in the study 
will be completely voluntary and will not impact employment status or benefits. 
Furthermore, participants will be assured that their data will be kept confidential and that 
they are free not to answer any questions.
To minimize the risk of psychological distress among CWs due to questionnaire 
completion, participants may skip any question that they do not wish to answer. CWs 
might also feel uncomfortable during receiving smoking cessation counseling from their 
safety manager. To minimize this risk, CWs will be informed that their participation in 
the study is voluntary and that they can withdraw from the study at any time. However, 
given the brief intensity of our intervention, and the strong relationship between safety 
managers and CWs, we anticipate that this risk is minimal. Safety managers are 
responsible for the safety and well-being of CWs, are trusted by the CWs, and have daily 
contact with them, which makes them optimal for the delivery of a sustainable smoking 
cessation treatment. Indeed, safety managers played key roles as liaisons between 
company leaders, researchers, and CWs in our pilot trial. They were also identified by 
leaders as the best people to deliver workplace tobacco treatment. 
Finally, to minimize risks associated with nicotine gum use, CWs will be provided with a 
thorough education on the nicotine gums' proper use, indications, possible side effects, 
and known health conditions that preclude their use. The gums are available over the 
counter; thus, they do not pose a significant health risk to most people. They contain 
minimal amounts of nicotine (which are much less than they get from smoking) and are 
absent from the remaining 7,000 toxins contained in cigarettes. 
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Safety managers might also feel uncomfortable while delivering the smoking cessation 
treatment to workers and conducting behavioral counseling. To minimize this risk, in 
addition to the two-day in-person training in the study procedures, safety managers will 
be asked to complete a 3-hour self-paced tobacco treatment online via the Florida Area 
Health Education Centers Network (AHEC) Cessation Program. This online program 
provides online tobacco cessation educational modules to deliver effective evidence-
based tobacco use treatment and cessation services. We will also use standardized 
treatment manuals and procedures. Safety managers will complete a checklist at the end 
of each session to document whether treatment components were delivered or not. 
Additionally, we will audiotape a random sample of 10% of counseling sessions for 
review and feedback during the study. Finally, safety managers will have a biweekly 
meeting with Dr. Asfar for monitoring, case review, and problem-solving.
9) Potential Benefits to Subjects*
There are no direct benefits to participating in the study. Participants will receive 
help to quit smoking and improve their health. 
10)
Vulnerable Populations*
None
11)
Setting
The two studies will take place at the Don Soffer Clinical Research Center at the 
University of Miami and at construction company sites.
12)
Resources Available
The PI of the study, Dr. Taghrid Asfar, has many years of experience in conducting 
smoking cessation trials. 
13)
Recruitment Methods
Three levels of recruitment are planned: 
1. Company leaders: We will recruit 8 companies for the study. We have secured 
letters of support from twelve construction companies that agreed to participate 
in the study (see LOS from leaders from 9 companies). We will organize a 
meeting with company leadership to discuss the project in detail and recruit 12-
18 company leaders (≈1-2/company) who are >18 years, and involved in 
decision-making, to participate in the implementation process. These 
individuals will be contacted by our research staff to sign the consent form and 
be enrolled in the study. 
2. Safety managers: We will recruit 20-25 (≈2/company) safety managers for the 
study. Twelve safety managers have already been recruited (see LOS from 
safety managers from 12 companies). All other safety managers in the 
participating companies will be invited to participate in the study. Those who 
-       Study #: 20230549        Effective Date: 8/15/2025

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are interested will be screened for eligibility, and our RAs will obtain electronic 
informed consent via REDCap. 
3. CWs: We will recruit 608 CWs for the study. As we did in our pilot study, the 
safety manager who participates in the study will describe the study to CWs at 
the end of their regular safety morning briefings and invite them to participate. 
Additionally, safety managers will receive flyers and posters to display on-site. 
The flyers will include study details and a QR code to collect participant contact 
information and screen them. Those who agree to participate will meet our RAs 
around the lunch truck during their lunch break to be screened and, if eligible, 
sign an electronic informed consent via REDCap. 
14)
Local Number of Subjects
We will recruit up to 12-18 company leaders (≈1-2/company), 20-25 safety 
managers (≈2/company), and 608 CW participants.
15)
Confidentiality
This study will be anonymous, and no identifying information will be collected. 
Participants will be only identified in transcripts, reports, or publications with a number 
that is not linked to their name. To ensure confidentiality, CWs screening will be done 
individually one by one) using the safety manager field office. CWs who are not eligible 
or decline to participate will be given a list of available cessation resources.
16)
Provisions to Protect the Privacy Interests of Subjects
Participants can be assured that the data they provide will only be seen by approved 
research staff, and they will not be identified in any publication. The Sylvester 
Comprehensive Cancer Center (SCCC) will monitor this clinical trial according to the 
Cancer Center’s data and safety monitoring (DSM) plan to assure the well-being of 
patients enrolled on Investigator-Initiated Trials that do not have an outside monitoring 
review.  If the PI have concerns about unexpected safety issues, the study will be stopped 
and will not resume until the issues are resolved. The SCCC DSM Plan to which this 
study is subject can also be found at www.sylvester.org.
17)
Consent Process
Participants will read the electronic consent form and indicate their consent in 
REDCap by checking the box prior to beginning the survey. Eligible company 
leaders will be contacted by research staff to complete the electronic consent form 
and be enrolled in the study. Safety managers who are interested will be screened 
for eligibility and complete the electronic consent form obtained by a RA via 
REDCap. Construction workers who agree to participate will meet our RAs 
during their breakfast or lunch break to be screened, and, if eligible, sign an 
electronic informed consent via REDCap.
-       Study #: 20230549        Effective Date: 8/15/2025