Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking

Study Overview
=================
Brief Summary
-----------------
This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus [vs.] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers. SECONDARY OBJECTIVES: I. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers. EXPLORATORY OBJECTIVES: I. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation. ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months. After completion of study, participants are followed up at 3 and 6 months.

Official Title
-----------------
Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities

Conditions
-----------------
Cigarette Smoker, Current Every Day Smoker

Intervention / Treatment
-----------------
* Other: Informational Intervention
* Behavioral: Telephone-Based Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female owning a cell phone with a reachable contact number Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status Smoked at least 100 cigarettes in lifetime Currently smoking at least 5 cigarettes a day, on average Willing to set a quit smoking date within a week of the enrollment English speaking Exclusion Criteria: Expired carbon monoxide (CO) levels below 7 ppm Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility) Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion) Pregnant or nursing Enrolled in another smoking cessation program Partner enrolled on current study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (mainstream instructional care)<br>Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of NRT in the form of nicotine patches, and intensive print materials to promote smoking cessation. | Other: Informational Intervention<br>* Receive advice to quit smoking and materials to promote smoking cessation<br>|
| Experimental: Arm II (tailored intensive care)<br>Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months. | Other: Informational Intervention<br>* Receive advice to quit smoking and materials to promote smoking cessation<br>Behavioral: Telephone-Based Intervention<br>* Receive individualized text based messages<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computing recruitment rate | Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided. | At baseline | 
| Retention rates | Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided. | At 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of helpfulness | Will be measured by asking: Were the text messages helpful in your attempt to quit smoking cigarettes? (Likert scale from 0= Not at all helpful to 4=Very helpful). Will use t-test to compare between arms. | Up to 6 months | 
| Appropriateness | Will be measured by asking: Regarding the number of text messages received per day, did you think that there were: (Likert scale from 0=Too many to 2=Not enough). Will use t-test to compare between arms. | Up to 6 months | 
| Perceived difficulty | Will be measured by asking: How easy was it to view the text messages? (Likert scale from 0=Not at all easy to 4=Very easy) How easy was it to respond to the text messages? (Likert scale from 0=Not at all easy to 4=Very easy). Will use t-test to compare between arms. | Up to 6 months |