Empowering Sexual and/or Gender Minority Tobacco Cessation: A Pilot Study
Phase: NA
Conditions: Smoking Cessation
Sponsor: University of Oklahoma

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RESEARCH PROTOCOL OUTLINE
Title of Project: Empowering sexual and/or gender minority tobacco cessation: A 
pilot study
Principal Investigator:
Julia McQuoid, PhD, Department of Family and Preventive 
Medicine & TSET Health Promotion Research Center
Abstract
Sexual and/or gender minority (SGM) people have disproportionately high rates 
of tobacco use – the number one cause of preventable death. Reasons for this 
include using tobacco to cope with social minority stressors, pro-tobacco use 
norms in SGM social spaces and networks, and targeted tobacco industry 
marketing. Empowerment Theory explains how positive behavior change, like 
quitting smoking, can be promoted through skills development with greater 
participation in the public affairs of one’s community. An empowerment 
approach may enhance tobacco cessation treatment for SGM people and other 
stigmatized groups because it links individual well-being with the larger social 
and political context. This pilot study will assess the acceptability, feasibility, and 
preliminary impact of empowerment-enhanced tobacco smoking cessation 
assistance for SGM adults. We will enroll N=20 SGM adults in Oklahoma who 
smoke and are willing to quit. Participants will receive standard tobacco cessation 
assistance through the Stephenson Cancer Center Tobacco Treatment Research 
Program (TTRP). Concurrently, they will also engage in ‘empowerment 
activities’, meaning SGM organizing and community-building activities, like 
conducting follow up phone calls to participants of a gender marker and name 
change clinic. This will be facilitated by an Oklahoman SGM-serving community 
partner. Participants will complete 12 surveys during the intervention period and 
12 weeks post-quit-date, a 60-minute, in-depth exit interview, and biochemically-
verified smoking status before the intervention and 12 weeks post-quit-date. This 
pilot study will establish collaborative relationships between the PI’s team and 
local SGM-serving organizations, and will produce preliminary findings to 
support future R01-level funding to conduct a fully powered randomized control 
trial of a multi-level empowerment-enhanced SGM tobacco cessation 
intervention.
A.
Specific Aims
State the hypothesis and specific aims.  List the long-term objectives and what the 
proposed research will accomplish.  
Aim 1: Assess the feasibility and acceptability of empowerment-enhanced tobacco 
cessation assistance for sexual and/or gender minority (SGM) adults. We will use 
baseline and exit surveys and in-depth interviews to assess retention, empowerment 
activity participation (e.g., number, duration, intensity, roles), and participants’ 
perceptions of the intervention. 
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Aim 2: Compare individual empowerment and cessation predictors pre- and 
postintervention. Hypothesis: Post intervention, participants will have (i) increased 
adaptive coping strategies, social support, and smoking abstinence self-efficacy; 
and (ii) decreased internalized SGM stigma. 
Aim 3: Assess tobacco cessation outcomes post-intervention. Hypothesis: The 
proportion of participants with biochemically-verified smoking abstinence at 12 
weeks post-quit-date will be equal to or greater than the general Stephenson Cancer 
Center Tobacco Treatment Research Program (TTRP) intervention (i.e., 18% 
biochemically-verified abstinence at 12 weeks1); medication and counseling 
adherence will be moderate/optimal for >50% of treatment weeks.
We will produce preliminary data on a novel SGM tobacco cessation approach 
and establish collaborative relationships with SGM-serving organizations. Our 
findings will support a future NIH R01 to conduct a fully-powered randomized 
control trial of a multi-level empowerment-enhanced SGM tobacco cessation 
intervention. A longer-term research program will refine tobacco treatment 
strategies tailored to SGM individuals.
B.
Background and Significance
Tobacco use – the number one cause of preventable death2 – disproportionately 
impacts sexual and/or gender minority (SGM) groups.3-6 In the U.S., 30% of 
sexual minority people use tobacco versus 20% non-sexual minority,7 and gender 
minority people are 2–3 times more likely than cisgender people to use tobacco.8 
Tobacco interventions that are tailored to priority groups, like SGM, aim to 
address unique drivers of use and barriers to cessation. Our work and others’ 
shows that SGM tobacco use is linked to how SGM people interact with and 
negotiate everyday environments as a social minority person.9-17 Drivers of SGM 
tobacco use include social minority stressors,9,16,18-21 pro-tobacco norms in SGM 
social networks and spaces,22-26 and targeted tobacco industry marketing.27-30 This 
is particularly true in states with high levels of structural SGM stigma, like 
Oklahoma (OK).31 SGM Oklahomans experience disproportionate mental health 
and material hardship32 and our preliminary data show that sexual minority adult 
Oklahomans are at greater risk for past 30-day tobacco use (51.6%) than non-
SGM (40.4%). Yet, tobacco cessation assistance tailored for SGM Oklahomans is 
unavailable. 
The past decade has seen increasing interest in tailoring tobacco control 
interventions to SGM people.33-35 While a minority of interventions engage with 
SGM social networks and spaces,36,37 most focus on individual-level factors (e.g., 
readiness to quit) and may not be equipped to address the unique person-
environment drivers of SGM tobacco use.38 An Empowerment Theory (ET)39-41 
approach to tobacco cessation may enhance efficacy for SGM Oklahomans because 
it links individual well-being with the larger social and political context.39-41 ET 
asserts that positive behavior change can be promoted through skills development 
with greater participation in the public affairs of one’s community.42 Individual 
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empowerment outcomes may include perceptions of personal control and a 
proactive approach to life.40 Efforts to exert control are central to ET approaches; 
empowering processes often involve participation with others to achieve goals, 
efforts to gain access to resources, and opportunities to more critically understand 
one’s sociopolitical environment.39,41 
ET approaches have not been used in SGM-tailored tobacco interventions, but 
have been shown to be efficacious, feasible, and acceptable for use in SGM 
HIV/STI prevention43,44 and youth-tailored tobacco interventions.45-47 For SGM 
people, SGM-related social change mobilization and community-building 
participation are linked to empowering outcomes, including more adaptive coping 
with minority stress, experiencing more meaning in life, greater community 
connection, 
and 
overall 
positive 
psychological 
functioning.48 
Minority 
Stressguided49 research on SGM people shows that as levels of coping and social 
support increase, so does engagement in health-promoting lifestyles.50  For SGM 
smokers, adaptive coping strategies,51 52 social support,52 smoking abstinence 
selfefficacy,53 and internalized SGM stigma54 may influence tobacco use and 
cessation behaviors, suggesting that empowerment activities may indirectly support 
tobacco cessation among SGM. We will pilot a novel tobacco cessation intervention 
that uses an empowerment approach focused on SGM community building to 
enhance smoking cessation outcomes for SGM Oklahomans.
This project is innovative because it is:
•
A novel application of a theoretical framework, Empowerment Theory, 
from parallel health behavior change fields to advance tobacco cessation assistance 
for a social group with persistent tobacco-related disparities.
•
The first SGM-tailored tobacco cessation intervention to integrate SGM 
empowerment activities with tobacco cessation assistance best practices to address 
person-environment drivers of SGM tobacco use.
•
The first SCC partnership with an SGM-serving organization to reduce 
SGM Oklahoman tobacco use.
C.
Preliminary Studies/Progress Report  
1. Provide an account of previous studies and/or information that establishes the 
experience and competence of the investigator to pursue the protocol. 
Team Expertise and Preliminary Data. Our team brings the requisite expertise in 
SGM tobacco disparities, tobacco cessation assistance for priority groups, 
community-engaged interventions, and SGM empowerment. PI McQuoid, Co-I 
Ehlke, and Drs. Heffner and Tan’s work55 shows the person-environment 
relationship drivers of SGM tobacco use, including using tobacco to cope with 
social minority stressors like fear of rejection and harassment.14-17,55-59 Co-I 
Kendzor is PI of the SCC Tobacco Treatment and Research Program (TTRP),60 
which will assist with study recruitment and enrollment and provide standard 
tobacco cessation treatment. Co-I Frank-Pearce has expertise in biostatistical 
analysis of TTRP data. Drs. Heffner, Tan, Durazo and Co-I Kendzor have expertise 
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in tobacco and other health interventions for priority groups, including SGM,61 
Latinx,62 and socioeconomically disadvantaged.63-68 PI McQuoid’s evaluation of a 
bar-based tobacco intervention for high-risk young adults found that immersive 
experiences that encourage a sense of collective purpose may enhance endorsement 
of anti-tobacco messaging.69,70 Ms. Horn has over 15 years of experience 
developing social change and community-building programming for priority 
communities, including SGM groups in Oklahoma.
D.
Research Design and Methods (What, When, How, Where)
Study overview. This study will assess the feasibility and acceptability of 
empowerment-enhanced tobacco cessation assistance for SGM adults. We will use 
a single-arm pilot design given funding, time, and sampling pool limits. Participants 
(N=20) will receive standard TTRP tobacco cessation assistance and concurrently 
participate in SGM empowerment activities. We will assess outcomes 
quantitatively and qualitatively. Primary outcome variables will be retention, 
perceptions of the intervention, adaptive coping strategies, biochemically-verified 
smoking abstinence at 12 weeks post-quit-date, and treatment adherence. 
Recruitment. We will enroll participants over a 4-month period and recruit through 
the TTRP, which serves an average of 30 SGM individuals per year without SGM-
targeted recruitment. We will supplement this by recruiting via local SGM-serving 
organizations, SGM targeted social media ads (e.g., Facebook), and snowball 
recruitment.
Eligibility criteria: Self-identify as SGM, 18+ years of age, report past 30-day 
combustible tobacco use (i.e., current smokers), willing to quit in the next two 
weeks, no contraindications for nicotine replacement therapy (NRT), reside in OK 
(verified with valid ID), willing to refrain from smoking any substance (e.g., 
cannabis) within 48 hours of expired carbon monoxide collection as this may impact 
biochemically-verified smoking abstinence.
Demographic sampling. Our racial and ethnic identity sampling targets roughly 
reflect the general Oklahoma population. The largest racial and ethnic groups in 
Oklahoma are Non-Hispanic White (65%), Hispanic (11.1%), American Indian 
(9.4%) Black/African American (7.8%), and two or more races (6.3%).71 For gender 
targets, we aim to recruit for an approximately even number of cisgender female, 
cisgender male, and ‘other gender’ identifying participants (e.g., transgender, 
gender non-conforming, gender queer, refuse to answer). Approximately 3% of the 
general TTRP participant pool identify within this ‘other gender’ identity group. 
We will aim to over-recruit for ‘other gender’ identifying participants given the 
SGM focus of this pilot study. For sexual identity, our recruitment aims will reflect 
the non-heterosexual identity groups in the TTRP participant pool; the largest of 
these is gay/lesbian (4.9%), followed by ‘unsure or refused to answer’ (2.5%) and 
bisexual (2%).
Intervention. Participants will receive standard TTRP tobacco cessation assistance 
either remotely or in-person: 6 weekly counseling sessions and 12 weeks of 
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combination NRT (nicotine patches + nicotine gum or lozenges). During the 6 
weeks of counseling, participants will also engage in 4 ‘empowerment activities’ 
(i.e., SGM social change mobilization and community building activities48) lasting 
approximately 1.5 hours each, with the option to do more if desired. Activities will 
be tailored to each participant’s comfort level and scheduling restraints. 
Below is a list of empowerment activities that may be offered to participants:

Compile publicly available, online information about school board meetings 
(locations, times, board contact information) into a spreadsheet. This 
spreadsheet will be made available to the public online to make it easier for 
people to be involved in their local schools.

Conduct online research regarding HIV resources and services (for example, 
testing sites) in Oklahoma and compile into a word document. This will be 
made available to the public online to make it easier for people to access 
HIV resources in Oklahoma.

Conduct phone calls using a script to gender marker and name change 
clinic72 participants to assess their needs and report those needs back to the 
clinic.

Conduct online research on the process to change gender markers and names 
in Oklahoma to be compiled into a resource document that will be made 
available to the public online.

Support preparation for public webinars to raise community awareness 
about local LGBTQ2S+ resources by conducting phone calls to community 
members who are part of Freedom Oklahoma’s network to assess what they 
would like to learn about in the webinars.

Support in-person community engagement events, like the community gala 
skate night, by helping with event registration, event set-up, and event take 
down.
Participants will complete the following assessments: (i) 12 surveys (baseline, exit, 
quit-day, 1-4 and 12 weeks post-quit-date, and immediately following 
‘empowerment activity’ participation for up to 4 sessions; (ii) biochemically-
verified smoking status at baseline and 12 weeks post-quit-date via expired carbon 
monoxide monitors; and (iii) a 60-minute in-depth interview over Zoom video chat 
within weeks 6-8 post-quit-date. Participants will be incentivized a total of $300 for 
the baseline survey ($25), 6 subsequent short surveys ($70), 4 empowerment 
activity feedback surveys ($100), 2 expired carbon monoxide tests ($20), , exit 
survey ($25), and 60-minute interview ($60). Participants are also eligible to 
receive up to two additional incentive bonuses for assisting in snowball recruitment 
of eligible participants who enroll in this study ($25 per referral, maximum of $50). 
Participants will be eligible for up to a $350 incentivized total. Freedom Oklahoma 
staff will participate in interviews and reflect on the intervention and Freedom OK’s 
role in it. Freedom Oklahoma will adopt a tobacco-free policy and provide feedback 
on the cultural competence of TTRP materials.
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Partnerships. TTRP will provide the standard tobacco cessation assistance. 
Freedom Oklahoma will design the empowerment activities. Freedom Oklahoma is 
a community-based organization in Oklahoma City that has worked to secure lived 
equality and legal protection for SGM Oklahomans for over 15 years. PI McQuoid 
and Freedom OK have held more than 4 project planning meetings over the past 
year. 
Measurement of Feasibility and Acceptability (Aim 1). We will use exit surveys 
and empowerment activity feedback surveys administered via REDCap to assess 
retention and self-reported empowerment activity participation (i.e., total hours, 
types of events/activities, roles played).73 We will cross-reference with research 
project records of empowerment activity participation. We will also qualitatively 
assess perceptions of the intervention by interviewing participants over Zoom video 
chat at 12 weeks post-quit-date. PI McQuoid, a qualitative methods expert, will 
train a team to conduct semi-structured, in-depth interviews lasting approximately 
60 minutes. We will elicit rich content regarding experiences of empowerment 
activity participation and tobacco cessation as an SGM person in Oklahoma. 
Interview guide domains will include: (i) best intervention aspects (e.g. highlights, 
peak experiences); (ii) biggest challenges or negative experiences; (iii) 
empowerment activity experiences; (iv) interactions of empowerment activity 
participation with tobacco cessation experiences; (v) outcomes and personal growth 
(vi) suggestions for intervention improvements. Interviews will be audio-recorded 
and professionally transcribed verbatim. 
Qualitative Analysis: We will use Dedoose qualitative data analysis software to 
conduct an inductive-deductive thematic transcript analysis with a priori themes 
derived from ET39-42,45-47,73 and SGM tobacco cessation literature.33-35 We will use 
an iterative codebook development process involving weekly team discussions, 
independent coding, and member checking of findings74 to enhance rigor and 
trustworthiness.75,76 We will also interview Freedom Oklahoma staff about their 
perceptions of the intervention and their organization’s role in it.
Measurement of Individual Empowerment and Cessation Predictors (Aim 2). 
We will compare individual empowerment and cessation predictors pre- and 
postintervention with baseline and exit surveys. We will assess predictors of 
smoking cessation51-54,77,78 and individual empowerment outcome measures 
adapted from a youth empowerment tobacco control model42,73 and SGM social 
change mobilization participation research.48 These will include: (i) adaptive 
coping strategies (Cognitive Emotion Regulation Questionnaire79), (ii) (v) social 
support (Relational Health Indices80), (iii) abstinence self-efficacy (Confidence 
Inventory81), and (iv) internalized SGM stigma (Internalized Transphobia and 
Pride82 and Internalized Homophobia items83). 
Measurement of Tobacco Cessation Outcomes (Aim 3). We will use benchmarks 
to assess participants’ tobacco cessation outcomes. Tobacco abstinence will be 
measured via self-report and biochemically-verified via expired carbon monoxide 
at baseline and 12 weeks post-quit-date. Treatment adherence will be assessed with 
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the 4-item Medication Adherence Questionnaire (MAQ)84 and counseling session 
attendance tracking.
Sample Size/Analysis Plan. Primary outcome variables will be: retention, 
perceptions of the intervention, adaptive coping strategies, biochemical verification 
of tobacco abstinence at 12 weeks post-quit-date, and treatment adherence. We will 
evaluate retention by calculating the proportion of participants who complete the 
final study visit at 12-weeks post-quit, with the goal of retaining >80% of 
participants. We will qualitatively evaluate perceptions of the intervention (as 
described above). We will use a two-sided paired samples t-test to examine the 
mean differences in adaptive coping strategies pre- and postintervention (α=0.05). 
Assuming 20% attrition and a standard deviation of differences of 4.085,  n=20 
participants will provide 80% power to detect a mean difference of 2.6 in adaptive 
coping strategies. Tobacco cessation outcomes will be considered successful if the 
proportion of participants with biochemically-verified smoking abstinence (expired 
carbon monoxide) at 12 weeks post-quit date is equal to or greater than the general 
TTRP sample (i.e., 18% at 12 weeks1). Treatment adherence will be considered 
successful with all participants having >50% of treatment weeks with an MAQ 
score indicating moderate/high adherence and counseling session attendance. 
Expected outcomes: Empowerment-enhanced tobacco cessation assistance will be 
acceptable and feasible (Aim 1), will increase within-subject empowerment and 
improve cessation predictors (Aim 2), and will meet benchmarks for tobacco 
cessation outcomes (Aim 3). 
Identifiers might be removed and the de-identified information may be used for 
future research without additional informed consent from the subject.
Potential problems and alternative strategies. COVID-19: All intervention 
activities can be conducted remotely, including cessation counseling, 
empowerment activities (e.g., remote phone banking), and mailing iCOquit devices 
(expired carbon monoxide) to participants. Retention: We budgeted for 25 
participants to allow for a 20% drop out rate. Some participants may not find certain 
empowerment activities acceptable and will be encouraged to continue TTRP 
tobacco cessation assistance. Recruitment: We have budgeted for contingency 
recruitment efforts, including contracting a specialized recruitment service (e.g., 
TrialFacts) and distributing press releases to regional media outlets.
Timeline. Month 1 Study preparation; Months 2-6 Recruitment and enrollment; 
Month 10 All 12-week follow-up visits will have concluded; Month 10-12 Data 
analysis and manuscript preparation. 
E.
Chart Review
N/A. This study is not conducting a chart review or electronic medical records.
F.
Biospecimens
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N/A. There will be no biospecimen collection in this study.
G.
Banking/Repository/Database
All data collected during the study will be retained for future use in tobacco and 
nicotine research. Data will be stored electronically on a secure password server 
that can only be accessed by approved study personnel. No biospecimens will be 
collected or stored.
H.
Inclusion / Exclusion Criteria
1.
List the criteria that will define who will be included in the study
•
≥18 years old
•
Self-identify as sexual and/or gender minority
•
Reside in the State of Oklahoma
•
Report past 30 day use of combustible tobacco 
•
Willing to quit using combustible tobacco within the next 2 weeks
•
English-speaking
•
Willing to refrain from smoking any substance, such as cannabis, within 
48 hours of expired carbon monoxide collection
•
Willing to complete all intervention components and data collection 
activities
2.
List the criteria that will define who will be excluded in the study. 
•
Have contraindications for nicotine replacement therapy (NRT)
3.
Provide early termination criteria.  
•
Participants will be terminated at any point during their study participation 
if they have stopped participating study activities and are non-responsive 
to 3 or more consecutive contact attempts from research staff. 
I.
Gender/Minority/Pediatric Inclusion for Research
The study has no inclusion/exclusion criteria based on race/ethnicity. We are 
specifically recruiting for cisgender women (target 35% of the sample) and gender 
minority identified people (i.e., transgender, gender non-conforming, other 
gender; target 30% of the sample) given the sexual and/or gender minority focus 
of this pilot intervention. We do not anticipate difficulty achieving this gender 
composition given that cisgender women have been easier to recruit than 
cisgender men in our past studies on tobacco and/or cannabis use and our 
recruitment efforts will specifically target the gender and sexual minority 
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community in Oklahoma. The PI has developed a strong working relationship 
with local SGM-serving organizations in Oklahoma, including our community 
partner on this proposal (Freedom Oklahoma), and has successfully targeted 
sexual and/or gender minority participants through targeted social media 
campaigns and community partner recruitment in past studies. All materials will 
be tailored to low-literacy populations to enhance inclusion of under-represented 
populations and minority groups.
J.
Recruitment and Enrollment
1.
Describe the plans for recruitment.
a.
Methods to identify and recruit potential participants
We will enroll participants (N=20) over a 4-month period and recruit through the 
Tobacco Treatment Research Program (TTRP), which serves an average of 30 
sexual and/or gender minority (SGM) individuals per year without SGM-targeted 
recruitment efforts. We will supplement this pool of SGM participants by recruiting 
for SGM participants through local SGM-serving organizations, SGM targeted 
social media ads (e.g., Facebook), and snowball recruitment.
•
Tobacco Treatment Research Program (TTRP) enrollments. The Stephenson 
Cancer Center’s TTRP follows an Institutional Review Board (IRB)-approved 
research protocol where participants are referred by a health care provider 
through the University of Oklahoma Health Sciences Center (OUHSC) 
electronic medical record. Community participants may contact the clinic via 
the web, email, phone, fax, walk-in and tablet connection (in certain 
circumstances). The TTRP responds to referrals by providing information about 
treatment options, screening participants, and scheduling them for standard 
TTRP treatment or for an ongoing trial (if eligible and interested). 
•
Local sexual and/or gender minority (SGM)-serving organizations. Freedom 
Oklahoma, a SGM-serving organization in Oklahoma City and the community 
partner on this proposal (See Letter of Support) will distribute recruitment 
materials to their extensive professional networks and channels of 
communication and will connect the research team to additional SGM-serving 
community organizations as needed to diversify the sample. Physical materials 
with study information will be printed as needed for distribution by SGM 
serving community organizations in Oklahoma and posted in public spaces 
(e.g., palm cards, flyers).
•
Targeted social media campaign. Participants will be recruited through paid 
advertisements on Facebook and Instagram that target SGM people who use 
tobacco and live in Oklahoma using a well-established campaign program 
managed by the University of Oklahoma Marketing team. Additional 
recruitment advertisements will be posted on Craigslist or other local 
advertising services and online forums as needed. 
•
Snowball recruitment. Participants will be invited and incentivized ($25 per 
referral of an eligible individual who enrolls in the study for a maximum of two 
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referrals and $50 additional at the end of their participation in the study)to share 
the study information and/or Dr. McQuoid’s contact information with anyone 
they think may be eligible and interested in participating in the study. 
2.
Describe the consent procedures to be followed
Informed consent. All study advertisements will provide a link to the study’s 
REDCap website with a short eligibility questionnaire. If respondents are 
eligible, they will be taken to the informed consent webpage, where will have 
the opportunity to consent. Dr. McQuoid’s contact information will be made 
available to participants to answer any questions about the study and to provide 
a way to inform the researchers at any point should they wish to withdraw from 
the study or have changed their minds about the use of their data.  All materials 
will be tailored to low-literacy populations (i.e., a 4th grade reading level).
Participants will be reminded that their participation is voluntary. Additionally, 
they will be reminded that they are allowed to discontinue participation in the 
study at any time, without any loss of benefits or other negative consequences. 
Individuals will be given as much time as they need to make a decision about 
participation; they will initiate their own consent on the informed consent at any 
time that they wish. The participant will be given a copy of the consent form to 
keep for his or her records. All research team members will complete an 
approved course on the protection of human subjects and be trained on how to 
clearly describe study procedures and the obtain informed consent process.
3.
Describe the location where consent is most likely to take place. Consent 
will most likely take place in the participants’ own home or any other 
location where they are accessing the consent webpage on their own device 
without the presence of a researcher.
4.
Describe provisions for recruiting non-English speaking participants. This 
study will not recruit non-English speaking participants.
5.
Describe measures to decrease participant coercion.
Several recommended approaches will be used to reduce coercion, including 
allowing participants ample time to review the consent, and using only 
qualified trained research staff to engage in the consent form process. 
Further, participants will be told in writing at the screening and at the time of 
consent that their participant is completely voluntary. They will be reminded 
during phone calls/video chat interactions with research staff and before and 
during the in-depth interview that they can decline to answer any question 
and they can withdraw their participation at any time without penalty.
K.
Risks and Benefits
1.
Describe risks and assess their likelihood and severity.
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The primary risks to participants are discomfort, loss of confidentiality, 
and medical side effects from FDA-approved Nicotine Replacement 
Therapy (NRT).
Discomfort may be experienced during participation in empowerment 
activities or the in-depth interview discussion, or due to some of the 
questionnaire items administered over the study period. 
A potential, although unlikely, risk to participants is loss of confidentiality. 
The severity of harm in the case of loss of confidentially may range from 
mild to severe depending upon the individual and the specific circumstances. 
However, the risks of participation in the study are similar to that of 
participation in standard care, as loss of confidentially may be experienced in 
either case. In addition, participant data residing on laptop/tablet computers 
and smart phones will be encrypted and password protected.
There is a risk of side effects associated with FDA-approved tobacco 
cessation medications; Nicotine Replacement Therapy (NRT): 
•
Possible risks of the nicotine patch include: increased blood pressure; 
skin redness, swelling, or rash; irregular heartbeat or palpitations; or 
symptoms of nicotine overdose including nausea, dizziness, 
weakness, and rapid heartbeat; and vivid dreams or sleep disturbance. 
•
Possible risks of nicotine gum include: increased heart rate and blood 
pressure; mouth, teeth, and jaw problems; irregular heartbeat or 
palpitations; symptoms of nicotine overdose including nausea, 
vomiting, dizziness, weakness, and rapid heartbeat; or allergic 
reaction such as difficulty breathing or rash. 
•
Possible risks of nicotine lozenges include: increased heart rate and 
blood pressure; mouth, teeth, and jaw problems; indigestion or sore 
throat; irregular heartbeat or palpitations; symptoms of nicotine 
overdose including nausea, vomiting, dizziness, weakness, and rapid 
heartbeat; or allergic reaction such as difficulty breathing or rash. 
Nicotine replacement medications may have enough medication to 
make children and pets sick.
2.
Describe procedures for protecting against or minimizing potential risks.
a.
Address measures instituted to protect the privacy and/or 
confidentiality of participant PHI 
Detailed protocols are in place to assess participant safety and respond 
effectively throughout participant engagement in this empowerment-enhanced 
tobacco cessation intervention pilot study, and to minimize risk of loss of 
participant confidentiality and data storage procedures.
General Procedures: Each participant will be assigned an identification 
number that will be utilized in place of names in all electronic and print data 
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files. The file containing the links between participant names and identifiers 
will be kept in a separate password-protected file, which will be destroyed 12 
months after the completion of the study. Any print information will be stored 
in a locked filing cabinet in the Principal Investigator’s locked office. 
Electronic data (with names omitted) will be maintained on the investigator’s 
computers, and all computers and electronic files will be password protected. 
Biochemical verification of smoking status will be collected in a private room 
in the TTRP. All project staff will complete extensive training focused on each 
of the following topics: 1) project rationale and objectives, 2) the informed 
consent process, 3) general data collection procedures (e.g., computer data 
collection, privacy), and 4) use of the carbon monoxide monitor. 
Minimizing risk of participant discomfort and side effects from FDA 
approved Nicotine Replacement Therapy (NRT):
Participant safety and level of distress will be assessed through research team 
members’ and TTRP counselors’ direct interactions with participants over 
video chat or in-person (including during interviews), on the phone, and during 
email correspondences. Specific protocols for participants who request 
substance use dependence treatment support, appear heavily intoxicated, 
and/or appear suicidal are provided below.
The Tobacco Treatment Research Program (TTRP) tobacco cessation 
assistance activities – including tobacco cessation counseling, biochemical 
verification of smoking status, nicotine replacement therapy, and 
administration of follow up surveys - follows a University of Oklahoma Health 
Sciences Center Institutional Review Board (IRB)-approved research protocol 
(PI: Darla Kendzor).
This study will not enroll individuals with contraindications for 
Nicotine Replacement Therapy (NRT).
Participants will be told prior to starting the study that their 
participation in research is voluntary and they may stop at any time.  Prior to 
beginning each empowerment activity participation session and the interview 
they will be reminded that they may choose to stop or pause the 
activity/interview at any time and may decline to answer any questions or 
engage in any activity that causes them discomfort. If a participant becomes 
distressed during the empowerment activity or interview they will be offered 
the option to stop or pause. 
Empowerment 
activity 
debriefing 
sessions. 
Following 
each 
empowerment activity participation session, the empowerment activity 
facilitator (a member of the McQuoid research team) will engage participants 
in a debriefing session to reflect on their experiences participating in the 
activity and any emotions or topics that arose for them. During this debriefing 
session, and during any other point of contact with participants, the activity 
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facilitator and research team will follow the protocol for ‘Vulnerable Subjects’ 
as needed (described below). 
Minimizing risk of loss of participant confidentiality and data storage 
procedures: 
All information obtained from participants will be kept completely 
confidential. Data will be stored as follows:
•
All data will be stored in secure locations to minimize the risk of breach 
of confidentiality, including locked file cabinets and password-protected 
computers and databases. Adverse events will be reported to the University of 
Oklahoma Health Sciences Center IRB, as appropriate, to ensure the safety of 
subjects’ information. 
•
All study questionnaires will be administered online with participants’ own 
devices or a study device using an electronic data capture system (REDCap) 
to maintain 21 CFR Part 11 compliance and Good Clinical Practice (GCP) 
standards. 
•
All transcripts from interviews will be stored on encrypted hard drives 
disconnected from the Internet and kept in locked file cabinets. 
•
Human subjects will be assigned coded participant ID numbers.
•
Files with identifying information will be stored separately from files with 
other forms of data (e.g., substance use status, mobility data, transcripts). 
•
Access to individually identifiable private information about human 
subjects will be had only by the individuals listed in this proposal. 
•
Study investigators have completed required University of Oklahoma 
Health Science Center training and certification in the conduct of research 
with human subjects.
Vulnerable Subjects:
This study focuses on tobacco cessation and empowerment for sexual and/or 
gender minority people in Oklahoma. Specific protocols will be in place to 
protect participant safety. See protocol in Data and Safety Monitoring Plan, 
below.
Clinical Resource to the Research Team: Dr. Jon Hart will serve as the 
clinical resource to the research team for this pilot study (PhD in Counseling 
Psychology, University of Oklahoma; NPI 1508236787; OK 1239). Dr. Hart 
is the Director of the Oklahoma Tobacco Helpline and Assistant Professor at 
the University of Oklahoma Health Sciences Center. He is a Licensed 
Psychologist whose expertise includes suicide prevention. Dr. Hart will train 
Dr. McQuoid and the rest of the research team in the study protocols designed 
to minimize risk to participants (described below) and will be available to the 
study team to discuss the protocols as needed throughout the duration of the 
study.
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3.
Describe potential benefits and importance to the participants and 
others. Potential benefits to participants include individual 
empowerment outcomes (e.g., more active coping strategies for 
minority stressors) and the possibility that the empowerment-
enhanced tobacco cessation intervention will have a beneficial 
impact on smoking cessation outcomes.
4.
Discuss why risks are reasonable in relation to benefits.
The knowledge gained from this study may be utilized to enhance efficacy of 
tobacco cessation assistance for sexual and/or gender minority (SGM) 
people, improve smoking abstinence rates in SGM populations, and thereby 
reduce tobacco-related disease and health disparities.
 
L.
Multiple Sites
N/A. This study does not involve multiple sites.
M. Statistical Methods  
Provide biostatistical design, power calculations determining the number of 
participants, and the proposed analysis. 
Dr. Summer Frank-Pearce, biostatistician, is a Co-Investigator on this project and 
informed the design of the statistical methods for this study.
This is a pilot study to assess feasibility and acceptability of an intervention.
Sample Size/Analysis Plan. Primary outcome variables will be: retention, 
perceptions of the intervention, adaptive coping strategies, biochemical 
verification of tobacco abstinence at 12 weeks post-quit-date, and treatment 
adherence. We will evaluate retention by calculating the proportion of participants 
who complete the final study visit at 12-weeks post-quit, with the goal of 
retaining >80% of participants. We will qualitatively evaluate perceptions of the 
intervention (as described above). We will use a two-sided paired samples t-test to 
examine the mean differences in adaptive coping strategies pre- and 
postintervention (α=0.05). Assuming 20% attrition and a standard deviation of 
differences of 4.085,  n=20 participants will provide 80% power to detect a mean 
difference of 2.6 in adaptive coping strategies. Tobacco cessation outcomes will 
be considered successful if the proportion of participants with 
biochemicallyverified smoking abstinence (expired carbon monoxide) at 12 
weeks post-quitedate is equal to or greater than the general TTRP sample (i.e., 
18% at 12 weeks1). Treatment adherence will be considered successful with all 
participants having >50% of treatment weeks with an MAQ score indicating 
moderate/high adherence and counseling session attendance. 
Expected outcomes: Empowerment-enhanced tobacco cessation assistance will be 
acceptable and feasible (Aim 1), will increase within-subject empowerment and 
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improve cessation predictors (Aim 2), and will meet benchmarks for tobacco 
cessation outcomes (Aim 3).
N.
Data and Safety Monitoring Plan 
Continuous monitoring and reporting of events will be undertaken by the Principal 
investigator (Dr. Julia McQuoid) and unanticipated problems will be promptly 
reported to the IRB. Since the standard smoking cessation treatment is offered by 
the Stephenson Cancer Center independent of this research proposal, adverse event 
monitoring will focus on events related to empowerment activity participation and 
study assessments. Possible adverse events might include compromised data 
security, and severe emotional reactions by participants due to participation in SGM 
social change mobilization and community building activities and/or questionnaire 
items.
Participant Safety Monitoring Plan:
This study focuses on tobacco cessation and empowerment for sexual and/or gender 
minority people in Oklahoma. Specific protocols will be in place to protect 
participant safety. See below.
Clinical Resource to the Research Team: Dr. Jon Hart will serve as the clinical 
resource to the research team for this pilot study (PhD in Counseling Psychology, 
University of Oklahoma; NPI 1508236787; OK 1239). Dr. Hart is the Director of 
the Oklahoma Tobacco Helpline and Assistant Professor at the University of 
Oklahoma Health Sciences Center. He is a Licensed Psychologist whose expertise 
includes suicide prevention. Dr. Hart will train Dr. McQuoid and the rest of the 
research team in the study protocols designed to minimize risk to participants 
(described below) and will be available to the study team to discuss the protocols 
as needed throughout the duration of the study.
PROTOCOL FOR REQUESTS FOR SUBSTANCE USE DEPENDENCE 
TREATMENT AND/OR CRISIS SERVICES:
Upon request, participants will be given the contact information for resources 
from the Substance Abuse and Mental Health Services Administration:
•
FindTreatment.gov - Millions of Americans have a substance use disorder. Find a 
treatment facility near you.
•
Suicide prevention lifeline 1-800-273-TALK (8255) Free and confidential support 
for people in distress, 24/7. 
•
National Helpline 1-800-662-HELP (4357) Treatment referral and information, 
24/7.
•
Oklahoma-specific Google map that allows users to select which type of resource 
they need, and then see which facilities in OK are licensed by 
ODMHSAS:https://www.google.com/maps/d/u/0/viewer?mid=137cjQWot11ah4u
Yf2vIE7hjRGU&ll=35.62854113370643%2C98.30299192656254&z=7  
PROTOCOLS FOR HEAVILY INTOXICATED PARTICIPANTS:
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During any point of contact with the research team or TTRP staff, participants may 
be heavily intoxicated and/or express thoughts of suicide or related ideation or 
thoughts of harming self-suggestive of suicidal risk. Participant safety will be 
monitored by researchers during in-person, phone, or email contact with 
participants. 
Below are protocols to be followed for heavily intoxicated and/or suicidal 
participants: 
Warning Signs for Intoxication
•
Unsteady gait
•
Breath that smells of alcohol
If a participant is heavily intoxicated or high at the time of participation, there are 
two issues that must be considered. First there is the issue of whether the participant 
should complete the study activity or return/reengage at a later date. The 
researcher/staff will need to make a judgment as to whether the participant can 
continue based on such factors as their ability to understand and complete activities, 
forms or interviews. The second issue to consider in the case of inperson data 
collection is whether the individual is safe to travel home at the end of the activity 
or assessment (if occurring in person). 
If the participant traveled from their home to another location for the study activity 
(e.g., our offices, the TTRP clinic) and there is any concern about the participant’s 
ability to get home safely or if the participant discloses that they are too “high” or 
intoxicated to continue with the assessments, the researcher/staff should secure safe 
transportation home for the participant and reschedule the assessment process. 
“I am concerned that you may be intoxicated right now. Is that true?”
If true, then you may say:
“If you are intoxicated, I don’t think this is a good time for us to continue with the 
interview/activity. But I am concerned about how you are going to get home safely. 
It is the study’s policy for you to stay here until you are okay to drive home. We are 
going to help arrange transportation.”
1.
Notify Dr. McQuoid by calling her at (cell) 510-672-0394.
2.
Give Dr. McQuoid the participant’s name, and any other relevant 
information you have. Ask for assistance in arranging for transportation.
3.
Have the participant talk with Dr. McQuoid over the phone, via video 
chat, or in person.
4.
Stay with participant (in person or virtually) until transportation arrives.
Note:  If the participant refuses this transportation assistance and insists on driving 
in an intoxicated state, they should be informed that the police will be called and a 
description of their car given and the direction it is heading.  
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PROTOCOLS FOR SUICIDAL PARTICIPANTS:
Acute Suicidal Warning Signs
•
The participant expresses hopelessness (e.g., “I’ll never get better”).
•
The participant makes direct or indirect statements about killing 
themselves, being better off dead, or things being better for others if 
participant wasn’t alive
If any participant makes a direct or indirect statement about suicide, hopelessness 
or death, even when said in a joking or off hand manner, this is a cause for concern. 
Sometimes suicidal people leave hints. It is not true that a person who talks 
frequently about committing suicide will not do it. Some keep their suicidal 
thoughts to themselves, while others do not. If a participant shows a desire or intent 
to kill her/him/their self, s/he/they should be evaluated by a qualified clinician to 
determine her/his/their level of risk and be connected to treatment setting that can 
ensure their safety. If you suspect that a person is in danger of killing her/him/their 
self, the interview should be stopped and specific focus should be made on the 
participant’s safety, and the protocol below should be followed:
To start, you should say:
"I am concerned about what you just said to me about your feelings/thoughts right 
now (e.g., “feeling so bad that you wish you were dead” or “thinking things are 
hopeless or would be better if you weren’t around”). I think this is really important. 
I need to connect you with someone to talk to who can help. I can give you the 
National Suicide Prevention Lifeline number for you to call privately, or we can do 
it together if that would be helpful."
Step-by-step process
1.
Stop the interview/activity
2.
Express concern for participant’s safety and well-being and the importance 
of getting participant the help they need to get through this difficult time (see 
script above)
3.
Encourage the participant to call the hotline and/or offer to call together: 

Toll-free, 24-hour hotline of the National Suicide Prevention Lifeline 1-800273-
TALK (1-800-273-8255) 
Your call will be connected to a trained counselor at a suicide crisis center nearest 
you.https://suicidepreventionlifeline.org/?utm_source=google&utm_medium=we 
b&utm_campaign=onebox   
4.
If the participant won’t call and/or disconnects the call and won’t 
reconnect, and you are concerned they are in imminent danger of hurting 
themselves or others, stay on the phone with them and ask them to “hold while 
you make a call to get some help to them.”
5.
Call 9-1-1 and request a CIT officer make a welfare check on an 
individual expressing an imminent desire to kill themselves. Cooperate with the 
91-1 operator to provide details about participant’s location and specific 
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statements that caused you to believe the individual was at imminent risk of 
suicide.
6.
If the participant is still on the phone, reassure them that you will stay on 
the phone until the help arrives. Wait with the participant on the line until they 
confirm the CIT officer has arrived at their location.
7.
Immediately following a referral to the suicide prevention lifeline or a 9-
11 welfare check call:

If in TTRP, inform TTRP supervisor on-call and inform them of the situation

If not in TTRP, call Dr. McQuoid at 510-672-0394 (cell) and inform her of the 
situation
8.
After you provide participant support and have informed either the TTRP 
supervisor or Dr. McQuoid, document the incident in RedCap in the participant’s 
file.
9.
The day following the incident, attempt to call the participant to follow up 
and schedule next study visit and/or leave a message requesting participant reach 
out when able.
The following statement has been included in the Informed Consent form so 
that participants are aware of this protocol:
What will happen if the research team thinks I am suicidal?
If, while we are interacting with you, any member of our research team or 
smoking cessation staff is concerned that you are in danger of killing yourself, 
you will be encouraged to call the National Suicide Prevention Lifeline or 9-1-1. 
If you do not agree to voluntarily call the Suicide Prevention Lifeline or 9-1-1, the 
study protocol requires the research team and/or staff member to call 9-1-1 and 
request a CIT officer provide a welfare check to ensure your safety.
O.
Data Sharing
De-identified data will be made available to outside investigators upon request. 
However, it is noteworthy that data collected as part of the current proposal will 
be from a small sample, and will not provide sufficient information from which to 
draw conclusions. Rather these data will support a larger, adequately powered 
trial, from which data may be more complete and useful to other investigators.
P.
Confidentiality 
General Procedures: Each participant will be assigned an identification number that 
will be utilized in place of names in all electronic and print data files. The file 
containing the links between participant names and identifiers will be kept in a 
separate password-protected file, which will be destroyed 12 months after the 
completion of the study. Any print information will be stored in a locked filing 
cabinet in the Principal Investigator’s locked office. Electronic data (with names 
omitted) will be maintained on the investigator’s computers, and all computers and 
electronic files will be password protected. Biochemical verification of smoking 
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status will be collected in a private room in the TTRP. All project staff will complete 
extensive training focused on each of the following topics: 1) project rationale and 
objectives, 2) the informed consent process, 3) general data collection procedures 
(e.g., computer data collection, privacy), and 4) use of the carbon monoxide 
monitor. 
Minimizing risk of loss of participant confidentiality and data storage procedures: 
All information obtained from participants will be kept completely confidential. 
Data will be stored as follows:
•
All data will be stored in secure locations to minimize the risk of breach of 
confidentiality, including locked file cabinets and password-protected computers 
and databases. Adverse events will be reported to the University of Oklahoma 
Health Sciences Center IRB, as appropriate, to ensure the safety of subjects’ 
information. 
•
All study questionnaires will be administered online with participants’ own 
devices or a study device using an electronic data capture system (REDCap) to 
maintain 21 CFR Part 11 compliance and Good Clinical Practice (GCP) 
standards. 
•
All transcripts from interviews will be stored on encrypted hard drives 
disconnected from the Internet and kept in locked file cabinets. 
•
Human subjects will be assigned coded participant ID numbers.
•
Files with identifying information will be stored separately from files with other 
forms of data (e.g., substance use status, mobility data, transcripts). 
•
Access to individually identifiable private information about human subjects will 
be had only by the individuals listed in this proposal. 
•
Study investigators have completed required University of Oklahoma Health 
Science Center training and certification in the conduct of research with human 
subjects.
Q.
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1.
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4.
Lee JGL, Griffin GK, Melvin CL. Tobacco use among sexual minorities in the 
USA, 1987 to May 2007: A systematic review. Tobacco Control. 
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Caceres BA, Brody A, Luscombe RE, et al. A systematic review of cardiovascular 
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Adults — United States, 2019. MMWR and Morbidity and Mortality Weekly 
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McQuoid J, Thrul J, Ozer E, Ramo D, Ling PM. Tobacco use in the sexual 
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Bennett K, Ricks JM, Howell BM. "It's just a way of fitting in:" Tobacco use and 
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Jannat-Khah DP, Dill LJ, Reynolds SA, Joseph MA. Stress, socializing, and other 
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Lee JGL, Agnew-Brune CB, Clapp JA, Blosnich JR. Out smoking on the big 
screen: tobacco use in LGBT movies, 2000–2011. Tobacco Control. 
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