SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups
Phase: NA
Conditions: Smoking Cessation
Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB APPROVAL DATE: 06/15/2022 
1 
SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority 
Groups 
NCT05029362
Version Date: 06/15/2022 
This protocol describes both a pilot study and a feasibility study, which are registered as two 
separate records. Refer to pages 3-6, for the pilot study (aim 2) registered as ClinicalTrials.gov 
record NCT05645354. 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB APPROVAL DATE: 06/15/2022 
2 
Protocol Title: 
SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual 
and Gender Minority Groups. 
Principal Investigator: 
Irene Tami-Maury, DMD, MSc, DrPH 
Co-Investigators: 
Hongyu Miao, Associate Professor in Biostatistics. 
Study Coordinator: 
N/A 
Population: 
Total 96 study participants (Part 2 = 30 study participants; Part 3 = 
80 study participants). 
Number of Sites: 
Single site. Data were collected in the field. 
Study Duration: 
July 2020 to December 2023. 
Subject Duration: 
Individual's participation will end 1 month after the smoking 
quit date (Part 2); Individual's participation will end 6 months 
after the smoking quit date (Part 3). 
Funding Agency: 
NIH/NCI (1K22CA 237639-01A1) 
Short Title: 
SmokefreeSGM 
GENERAL INFORMATION 
Smoking among sexual and gender minority (SGM) groups, which include lesbian, gay, bisexual, and 
transgender (LGBT) individuals, has been reported from different sources as highly prevalent (46% for gay 
men and 48% for lesbians). Considering that the smoking rate within SGM groups is more than double that of 
the general population (19%) and that smoking accounts for at least 30% of all cancer deaths, it is clear that 
there is an increased risk for SGM individuals to suffer from this fatal condition. Text messaging programs are 
effective for smoking cessation and other health behaviors. They are appealing to traditionally hard-to-reach, 
at-risk populations who experience barriers to smoking cessation interventions, and who have high rates of 
mobile phone and text messaging use, which is the case for SGM users. SmokefreeTXT is a smoking 
cessation intervention that sends tailored, supportive texts to users based on self-selected smoking quit date. 
Although this program developed by the NIH National Cancer Institute (NCI) has been successfully evaluated 
with the general population, no study has evaluated its feasibility specifically among SGM smokers. This 
protocol proposes 3 specific aims or parts: 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB APPROVAL DATE: 06/15/2022 
3 
 
 
(1) To develop SmokefreeSGM, an SGM-tailored version of SmokefreeTXT, a text-based smoking cessation 
program. 
IRB NUMBER: HSC-SPH-20

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB APPROVAL DATE: 06/15/2022 
4 
 
 
 
(2) To pretest the design of SmokefreeSGM through a mixed-methods approach among 30 SGM adult 
smokers; and 
(3) To examine recruitment, retention, and smoking abstinence rates at 1, 3, and 6 months of follow-up 
among 80 SGM smokers randomized to either the original SmokefreeTXT or SmokefreeSGM program arms. 
Engagement with the programs will be also measured by calculating the number of text message responses 
for each SGM participant from the system records. Additionally, we will use mixed-methods research among 
32 SGM smokers completing their participation in the feasibility trial to better understand study participants’ 
acceptability of the cessation interventions. Results will contribute to reducing tobacco-related health 
disparities among SGM groups. 
 
BACKGROUND INFORMATION 
 
Cigarette smoking among SGM groups in the United States (US) is higher than among 
heterosexual/straight individuals. Nearly 1 in 4 SGM adults smoke cigarettes compared with about 1 in 6 
heterosexual/straight adults.1 This high rate is attributed to several factors, including additional stress due to 
stigmatization and discrimination, as well as targeted tobacco marketing.2 Four percent of adults in the US 
self-identify as SGM.3 However, the US Census and other major federal surveys do not ask about sexual 
orientation. Therefore, the number could be substantially higher. Texas has the third-highest concentration 
of same-sex couples in the US, behind only California and New York.4 Our study involving attendees of the 
2014 Houston Pride Parade and Festival confirmed the alarmingly high prevalence of cigarette smoking in 
this vulnerable group (55%).5 Considering that smoking accounts for at least 30% of all cancer deaths,6 it is 
clear that there is an increased risk for SGM individuals to die of tobacco-related conditions, including 
cancer. It has been suggested that targeted and tailored interventions could be more effective among SGM 
smokers because they assure a safe, validating environment that enhances receptivity to cessation.7,8 The 
few reported smoking cessation interventions for SGM smokers are minimally tailored, lack a control group, 
lack objective verification of self-reported quit rates, and/or are based on group interventions.9-12 Mobile 
health (mHealth) programs that use text messaging are effective for smoking cessation and other health 
behaviors.13-15 These programs are appealing to vulnerable groups who experience barriers to smoking 
cessation interventions16-18 and who have high rates of mobile phone and text messaging use.19 Although 
the number of people enrolled in text messaging programs for smoking cessation is increasing, no study 
has been conducted for evaluating its feasibility among SGM smokers. SmokefreeTXT is an automated, 
personalized, and interactive mHealth program for smoking cessation developed by the NCI that sends text 
messages 2 weeks before and up to 6 weeks after the quit date. Its efficacy was successfully evaluated 
with the general population in a randomized trial.15,20,21 However, theoretically-based smoking cessation 
treatments delivered via text messaging and focused on enhancing treatment engagement and targeting 
the specific needs of SGM smokers are needed. 
IRB NUMBER: HSC-SPH-20-0318 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
3 
 
 
 
 
OBJECTIVE 
 
The overall objective of the study is to develop SmokefreeSGM, a version of SmokefreeTXT that will be 
tailored and tested among SGM smokers. This protocol proposes 3 aims, each of them corresponding to 
Parts 1, 2, and 3 in this research study: 
▪ Aim 1: Developing the design of SmokefreeSGM (Part 1). 
▪ Aim 2: Pretesting the design of SmokefreeSGM among 30 smokers (Part 2). 
▪ Aim 3: Feasibility trial to examine recruitment, retention, and smoking abstinence rates 
among SGM smokers. We will also assess program engagement and acceptability among 
SGM smokers who participated in the feasibility trial (Part 3). 
 
NOTE: We are still enrolling study participants for all research activities related to Aim 2 (Pretesting). With 
this protocol amendment, we are seeking IRB approval to increase the sample size from 16 to 30 
individuals, as several recruited study participants are lost in follow-up. Once activities with Aim 2 are 
completed, subsequent protocol amendments will be submitted for Aim 3. 
 
OVERALL STUDY DESIGN. With this project, we propose to develop and test the feasibility of a 
personalized, interactive text-based smoking cessation program (SmokefreeSGM) specifically 
designed for SGM smokers. Ninety-six SGM smokers will be recruited for the entire study 
(n=96). 
 
 
 
RESEARCH METHODS FOR PART 1 
Procedures: In part 1, we will develop SmokefreeSGM, an SGM-tailored version of SmokefreeTXT, 
a text-based smoking cessation program for smoking cessation. SmokefreeTXT is an automated, 
personalized, and interactive mHealth program that sends bidirectional text messages timed 
around a participant’s quit date over 3 months. It was developed by NCI. The text messages 
include pre-and post-quit educational messages, peer ex-smoker messages, NRT medication 
reminders, and relapse messages, as well as multiple opportunities for interaction. Messages are 
based on social cognitive theory22, 23 and are consistent with the US Public Health Service Clinical 
Practice Guideline.23 Messages are interactive and prompt users to track smoking, report cravings, 
and provide smoking status. Participants who report that they have not quit are routed into setting 
a new quit date. After enrollment, SmokefreeTXT offers both outgoing messages about quitting 
smoking and on-demand help through the use of keywords. Short Message Service (SMS) 
keywords include among others: CRAVE (study participants will get help with a craving by having a 
reminder of why the study participant should not smoke that cigarette, MOODIR(BpaNrUticMipBaEnRt:wHiSllC-SPH-20-0318 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
4 
 
 
 
receive a positive message when having a difficult day, SLIP (user will receive extra 
encouragement to get back on track), and SMOKEFREE STATUS (which indicates if the study 
participant has smoked or not by the time he/she receives the text message). 
 
SmokefreeSGM will be developed by Dr. Tami-Maury’s research team with input and feedback 
from members of a Community Advisory Committee (CAB) composed of smoking cessation 
specialists, SGM former and current smokers, as well as scientists and community leaders with 
whom we have teamed up in previous research and advocacy efforts around SGM health 
disparities research. These CAB members should not be considered research participants. They 
will only provide feedback on the content and design of the SGM-tailored text-based platform. The 
CAB members will be compensated for completing a two-part survey ($15 eGift Card after 
completing each part). Further, we will solicit meetings with CAB members either individually or in 
a group via a telehealth platform (i.e., Zoom or Webex). After each meeting, which won’t last more 
than 60 minutes, CAB members will receive a $15 eGift Card. CAB members will be requested to 
attend up to 4 meetings during the entire duration of the study. 
 
Below are some of the SGM-tailored features we have anticipated for SmokefreeSGM: 
o Messages originated from SmokefreeSGM will be sent by a fictitious peer ex-smoker SGM quit 
coach (Alex) who will offer evidence-based advice on quitting. 
o The characteristics of, and messages sent by, the role model (Alex) will be based on real-life 
experiences of SGM ex-smokers who understand user’s barriers and creates a welcoming 
environment. 
o Modifying and tailoring of the NCI SmokefreeTXT text library (Appendix A) by adding 70 
encouragement and motivational messages that address unique psychosocial stressors for SGM 
smokers such as elevated general stress (i.e., level of stress and number of stressful life events) 
and minority specific stress (i.e., internalized homophobia, sexual orientation concealment, 
discrimination events, stigma consciousness). The new keyword STRESS will prompt the 
additional set of text messages. 
 
RESEARCH METHODS FOR PART 2 
Study Design. In part 2, we will pretest the design of SmokefreeSGM using a mixed-methods 
approach among 30 SGM adult smokers. 
 
Study Population. 
 
▪ Aim 2: Pretesting the design of SmokefreeSGM (n=30). Once developed, SmokefreeSGM 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
5 
 
 
 
will be beta-tested by 30 SGM adult smokers for 2 weeks before and 4 weeks after the quit 
date. Then, beta users will participate in individual interviews. The feedback provided by 
the study participants during the individual interviews will indicate if the messages were 
perceived as interesting and appropriate. Their thoughts and feedback will be critical for 
driving technical improvements of SmokefreeSGM’s concept, design, and functionality 
before launching it during the feasibility trial (Part 3) targeting SGM smokers who have not 
participated in the above-mentioned beta-test. 
 
Inclusion Criteria. 
 
1) Self-identified as a lesbian, gay, or bisexual individual 
 
2) Age ≥ 18 years 
 
3) Smoke five or more cigarettes per day, has smoked at least 100 cigarettes in their 
lifetime and smokes everyday 
4) Have an interest in quitting smoking in the next 15 days 
 
5) Have a cellphone number with an unlimited short messaging service (SMS) 
plan 
6) Have US mailing and email addresses 
 
7) Positive cotinine saliva test results for current smoker status 
 
 
Exclusion criteria. 
 
1) Individuals who are found to have a prepaid cell phone (GoPhone or pay-as- 
you-go plan) will be excluded, 
2) Individuals who are found to have a cellphone number that does not work or is 
registered to someone else will be disqualified, 
3) Pregnant or breastfeeding women (nicotine patches are not generally 
recommended to this group as nicotine can affect fetal and neonatal brain 
development), 
4) Contraindication for nicotine patch. Absolute contraindications included: severe 
eczema or serious skin conditions, allergy to nicotine patch, pregnancy, 
breastfeeding, heart attack in the past 2 months, ongoing angina, peptic ulcer 
disease, arrhythmia, or uncontrolled blood pressure. Potential contraindications 
included stroke in the past 6 months, insulin therapy, and a current diagnosis of 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
 
liver, kidney or heart disease. Participants reporting an absolute contraindication are 
ineligible for the study. A participant reporting a potential contraindication will require 
that his/her primary care provider and/or other treating physician (e.g. psychiatrist) 
approve the nicotine patches. If the request is denied or not returned in two weeks, 
potential participants will be excluded from the study; 
5) Current use of tobacco cessation medications; 
 
6) Enrolled in another smoking cessation study; 
 
7) Non-English speakers. Although we recognize that excluding Spanish speakers 
(Hispanics represent 44% of the total population in Houston)24 limits the 
potential generalizability and reach of our text-based smoking cessation program. 
We do not believe that developing and delivering an SGM- tailored intervention in 2 
languages is feasible within the scope of this study. 
8) Having inadequate equipment/device (i.e., webcam, speakers, mic) for 
participating in telehealth sessions via Webex or Zoom AND cannot 
meet for an in-person screening. 
 
Study Procedures. 
 
Once developed, SmokefreeSGM will be beta-tested by 30 SGM adult smokers for a period 
of 2 weeks before and 4 weeks after their quit date. 
 
Recruitment procedures. Active efforts will be made to identify subjects who are suitable for 
enrollment into this part of the study. Flyers (Appendix B) offering help to SGM individuals 
interested in quitting smoking will be distributed at local community organizations and 
healthcare facilities working for SGM groups. We will also advertise the flyer at local 
newspapers, magazines, webpages, social media sites of local community organizations and 
healthcare facilities, and SGM-venues (e.g., bars, restaurants, etc.). 
Interested individuals will contact the study team. The screening process will take place over 
the phone or through telehealth (e.g., Webex or a similar platform), or in person, and is divided 
into two parts. Part A of the screening (conducted over the phone, in person, or through 
telehealth) collects demographic information inaddition to an assessment of the 
inclusion/exclusion criteria (Appendix C). Participants who areeligible to participate in the study 
will be invited to complete part B of the screen (through telehealth, or in person) at a later 
date/time where self-reported smoking status will be verified by saliva. Informed consent will be 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
delivered electronically to participants via email after they complete part A of the screening and 
schedule their part B screen (Appendix D). In order to avoid in-person visits, the self-reported 
smoking status will be objectively verified by cotinine test (either Alere or NICDetect) during 
screening part B (Appendix E). However in-person visits will be conducted in the circumstances 
that videoconferencing technology or other barriers exist for screening. Potential study 
participants will be mailed in advance a saliva cotinine test with instructions (delivered 
electronically), or provided the test in-person. During part B of the screening process, 
participants will conduct the test at home or in person following the step-by-step instructions 
provided by the research staff. The test result will be available when the colored band appears, 
which takes around 10 minutes. The whole procedure of objectively verifying thesmoking status 
with the saliva test will be closely monitored during a second telehealth session.Potential study 
participants will be asked to show the result of the saliva test strip during the telehealth session 
or to the researcher in person. After enrolling into the study, participants will receive a 4-week 
supply of nicotine patches (NicodermCQ or CVS Health) that will be mailed to their physical 
address. 
 
Baseline assessment. Immediately after confirming their eligibility and enrolling the 
participant into the study, additional questions will be asked to complete the baseline 
assessment. 
Quantitative Measures. The following data will be collected: contact information (name, 
email address, phone number), demographic (race/ethnicity, work status, education, 
marital status, number of children in household), and smoking characteristics of 
participants (e.g., how many smokers in the household, cigarettes smoked/day, past 
quit attempts, age of first cigarette use). Nicotine dependence will be measured with 
the Fagerstrom Test for Nicotine Dependence (FTND) at baseline. The FTND is a 
standard instrument for assessing the intensity of physical addiction to nicotine. The 
test was designed to provide an ordinal measure of nicotine dependence related to 
cigarette smoking. It contains six questions that evaluate the quantity of cigarette 
consumption, the compulsion to use, and dependence. In scoring the FTND, yes/no 
items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The 
items are summed to yield a total score of 0-10. The higher the total FTND score, the 
more intense is the study participant's physical dependence on nicotine. After 
completing the baseline assessment, participants will receive a $15 egift card, which 
will be distributed by email. 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
1- Month Follow-up assessment. Study participants will complete follow-up assessment via 
telehealth session 1 month after their quit date. 
Quantitative Measures. This assessment will include the following items: contact 
information, sexual orientation, gender identity, living with one or more smokers in the 
household, cigarettes smoked/day, quitting attempts, nicotine patch use and FTND. We 
will also include the System Usability Scale (SUS) score which measures the usability 
of the SmokefreeSGM program (Appendix G). The SUS is a 10-item questionnaire with 
5 response options ranging from Strongly Disagree (1) to Strongly Agree (5): 
1. I think that I would like to use this text-based smoking cessation program 
(SmokefreeSGM) frequently. 
2. I found SmokefreeSGM unnecessarily complex. 
3. I thought SmokefreeSGM was easy to use. 
4. I think that I would need the support of a technical person to be able to use 
SmokefreeSGM. 
5. I found the various functions in SmokefreeSGM were well integrated. 
6. I thought there was too much inconsistency in SmokefreeSGM. 
7. I would imagine that most people would learn to use SmokefreeSGM very 
quickly. 
8. I found SmokefreeSGM very cumbersome to use. 
9. I felt very confident using SmokefreeSGM. 
10. I needed to learn a lot of things before I could get going with 
SmokefreeSGM. 
 
For completing the qualitative measurements during the 1-month assessment, 
participants will receive a $25 eGift card, which will be distributed by email. 
 
Qualitative Approach. During the 1-month assessment, while participants are scoring 
the SUS items, an interviewer will be using probes (e.g., Why do you think so?, What 
makes you feel that way?, etc.) to elicit further information. 
 
The entire 1-month follow-up assessment will last 45 to 60 minutes. A research staff member will act 
as a note-taker and will record the sessions. Findings from this mixed-method approach will indicate 
if the messages were perceived as interesting and appropriate. Their thoughts and feedback will be 
also critical for driving technical improvements of SmokefreeSGM’s concept, design, and 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
functionality before launching it during the feasibility trial (Part 3, not presented in this protocol 
amendment) targeting SGM smokers who have not participated in the above-mentioned beta-test. 
Following completion of the 1-month assessment, participants will be mailed either a 6-week supply 
of nicotine patches (NicodermCQ or CVS Health) or a 4-week supply to their physical address, 
depending on if they are a heavy smoker (smoke > 10 cigarettes/day) or light smoker (smoke ≤ 10 
cigarettes/day). 
Data Safety and Monitoring. This is a minimal risk study. The risks of using the text-based 
platform, completing the 1-month assessment, and/or participating in the in-depth interviews are 
considered minimal and include 1) emotional discomfort due to discussions about sensitive issues, 
and 2) breach of confidentiality. Distress will be minimized by assurances that participants can stop 
texting or refuse to answer any questions during the individual interviews if they do not feel 
comfortable answering and may withdraw from the project at any time without repercussion. 
Confidentiality will be maintained by numerically coding all data and by password-protecting 
computer files. Data will be stored on a secure server with a firewall to protect the data and to 
prevent unauthorized access. Databases on the server are password protected and will be 
accessed only by members of the research staff who have met the UTHealth IRB’s requirements 
for training in Human Subjects’ Protection. All participants will be assigned a unique identification 
code that will be stored separately from identifying information. All electronic datasets will be saved 
in the institutional shared drive and only research team members will be able to access them. The 
text messaging program will be implemented by the vendor, Mosio. Mosio is hosted by Lightcrest, 
an established, trusted vendor with documented security and regulatory compliance through 
Equinix. For data protection redundancy, backups are hosted using AWS HIPAA eligible services in 
a geo-diverse location. All Production and backup data centers are located within the USA. 
 
Statistics. Quantitative data collected via text messaging will be downloaded as an Excel, SPSS, R, 
SAS, or STATA dataset. These software packages will be used for analysis purposes. Study 
variables will be summarized using standard descriptive statistics. The distributional characteristics 
of relevant variables will be examined using box plots and histograms to ensure normality 
assumptions. Routine descriptive statistics, including proportions, means, and standard deviations 
as well as graphical methods will be reported to explore distributions for all variables. Engagement 
will be assessed among study participants’ data by analyzing the received and sent text messages 
collected during the smoking cessation intervention. The number of text messages sent and received 
by study participants after enrollment will be assessed. 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
We will also compute the scores for the SUS scale which will allow our research team to analyze 
how well the study participants perform the tasks on the text-based platform, and how they find the 
entire experience. Participants will have ranked each of the SUS 10 questions from 1 to 5, based on 
their level of agreement (1 for Strongly Disagree to 5 for Strongly Agree). 
 
● For each of the odd numbered questions, we will subtract 1 from the score. 
● For each of the even numbered questions, we will subtract their value from 5. 
● We will take these new values and add up the total score. Then, we will multiply this 
by 2.5. After computing the SUS score, we will convert it to percentile ranks. A 
percentile rank of 75% will indicate that SmokefreeSGM has a high perceived 
usability. 
 
Qualitative data from each individual interview will be analyzed for assessing usability and 
acceptability. Audio recordings from the individual interviews will be transcribed. Data will be 
analyzed by the research team using a descriptive framework approach which allows for the 
exploration of a priori concepts and for new themes to emerge. Transcripts will be read and reread 
to gain familiarity with the subject. Analysis of the transcripts will be based on data grouping, creation 
of a code guide, and identification of themes from the narrative text. The coding guide will be drawn 
on the domains shaped by the discussion guide and themes that will emerge during the study. Data 
analysis will be performed using computer software (ATLAS.ti or NVivo). Results will inform the 
refinement of a smoking cessation text-based intervention focused on enhancing treatment 
engagement and targeting the specific needs of SGM smokers. 
 
Ethics. This study involves no more than minimal risk to subjects. The risk of breach of 
confidentiality will be handled by indicating to participants that participation in the study and the 
information gathered from the study will be kept confidential to the extent of the law, and that the 
findings of the study may be published, but that participants will not be identified. No direct 
benefits to participating in this research are anticipated. Nevertheless, this research may benefit 
others since this work may contribute to a greater understanding of mechanisms underlying the 
acceptability of mobile health (mHealth) smoking cessation interventions among SGM groups. 
Results will contribute to the design of interventions targeting this underserved population of 
smokers. 
 
Data handling and record keeping. Participants will be assured that assessment information will 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
be kept confidential, and no names will be used in presenting data in presentations and 
publications. All data collected through REDCap instruments (e.g., screening forms, baseline, and 1- 
month assessments, etc.) will be available only to the research personnel, who are knowledgeable 
of all human subjects’ protection guidelines. Electronic datasets will be password protected and only 
accessed by research team members. 
 
Quality control and assurance. Research team members involved in the study will be trained in 
human subjects’ research. Team members will be available during data collection procedures 
respond via phone call or through telehealth to any question that study participants could have. 
Each research record (e.g., screening form) from each enrolled participant will be checked to verify 
that the inclusion/exclusion criteria have been respected. 
 
Publication plan. No text-based smoking cessation intervention has been specifically tailored to SGM 
populations, incorporating text messages with SGM-specific information focusing on affirmative-based 
approaches and coping strategies for unique SGM psychosocial stressors (e.g., internalized 
homophobia, discrimination events, stigma consciousness), among others. Evaluating the design of 
SmokefreeSGM will provide an opportunity to enhance the usability of this SGM-tailored text-based 
cessation program before launching it in Aim 3. At least one manuscript with findings from Part 2 is 
expected to be published in a peer-reviewed journal. 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
Appendices.  
▪ Appendix A: NCI SmokefreeTXT and SmokefreeSGM text libraries 
 
▪ Appendix B: Flyer 
 
▪ Appendix C: Screening form-Part A (Beta Testing: Part 2 of the Study) 
 
▪ Appendix D: Informed Consent (Beta participants) 
 
▪ Appendix E: Screening form-Part B, Cotinine Results, Baseline Assessment (Beta Testing: Part 2 
of the Study) 
▪ Appendix F: 1-Month assessment 
 
▪ Appendix G: System Usability Scale and Structured interview guide (Beta Testing: Part 2 of the 
Study) 

Principal Investigator: Irene Tami-Maury, DMD, MSc, DrPH 
IRB NUMBER: HSC-SPH-20-0318 
IRB APPROVAL DATE: 06/15/2022 
 
 
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