Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

Not Applicable

Completed

• Conditions: Cigarette Smoking
• Interventions: Behavioral: Culturally Targeted Cessation Program; Behavioral: Non-Targeted Cessation Program

• Registration Number: NCT01633567
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

For the approximately 4.6 million LGBT persons in the U.S., smoking rates among those living in urban areas are roughly twice that of heterosexuals. Targeted interventions have shown great promise in reducing health risk behaviors across a variety of behaviors and population groups by enhancing the relevance of the health information. The primary aim of this study is to test the efficacy of a culturally targeted group-based smoking cessation intervention (vs. a non-targeted intervention) on smoking outcomes among lesbian, gay, bisexual, and transgender (LGBT) smokers. The investigators anticipate that the culturally targeted intervention will be more effective at helping LGBT smokers to successfully stop smoking than will the non-targeted intervention.

Detailed Description

In Phase 1 of this study we used focus groups to establish the cultural appropriateness and acceptability of the targeted elements of the intervention for the LGBT population. For Phase 2 of this study, we seek to enroll 400 participants in a randomized controlled trial of the targeted intervention vs. a non-targeted, comparison condition. Both conditions will consist of group counseling sessions combined with nicotine replacement therapy and peer support. We expect that quit rates, stage of readiness, perceived benefits, self-efficacy, and treatment adherence will be higher among those who received the targeted intervention than those in the non-targeted intervention. Furthermore, we expect that a stronger LGBT cultural identification and salience of that identity will be associated with more satisfaction and adherence to the targeted intervention.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-07-01
• Study First Posted: 2012-07-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Self identify as lesbian, gay, bisexual, or transgender
• Age 18-65
• Current cigarette smoker
• Desire to quit smoking (self-report rating of interest in quitting)
• Relatively healthy, with no medical conditions that would adversely interact with study parameters (see exclusion criteria for specific details)
• Agree to attend behavioral counseling sessions, be randomized, and be followed-up
• Agrees to use nicotine patch and has no prior adverse reactions to patch
• Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend for contact and follow-up.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culturally Targeted Cessation Program	Culturally Targeted Cessation Program	The culturally targeted program will include the same cognitive and behavioral approaches and smoking education content that is used in the standard program. As such, we will maintain the integrity of the core program. However, cultural targeting of that program has been informed by local LGBT focus group input and testing, the available literature on LGBT smoking rates and behaviors, feedback from a panel of LGBT health experts, and data collected as part of a previous study.
Non-Targeted Cessation Program	Non-Targeted Cessation Program	Non-culturally targeted program with cognitive and behavioral approaches and smoking education content.

Primary Outcome Measures

Name	Time	Method
7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date	Assessed 6 months after quit date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date	Assessed 1 month after quit date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date	Assessed 3 months after quit date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.
7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date	Assessed 12 months after quit date	7-Day point prevalence smoking quit rates will serve as the main outcome measure and will be obtained from Time Line Follow-Back (TLFB) interviews.

Trial Locations

Locations (1)

Howard Brown Health Center; 🇺🇸 Chicago, Illinois, United States