Culturally Targeted & Individually Tailored Smoking Cessation Study: LGBT Smokers

May 3, 2017 updated by: Alicia Matthews, University of Illinois at Chicago

A Culturally Targeted and Individually Tailored Smoking Cessation Intervention for LGBT Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60613
        • Howard Brown Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Culturally Targeted Cessation Program
The culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
ACTIVE_COMPARATOR: Non-Targeted Cessation Program
Non-culturally targeted program with cognitive and behavioral approaches and smoking education content.
Behavioral: Non-Targeted Cessation Program
Behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-Day Point Prevalence Smoking Quit Rates 1 Month Post Quit Date
Time Frame: 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.
Assessed 1 month after quit date
7-Day Point Prevalence Smoking Quit Rates 3 Months Post Quit Date
Time Frame: 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.
Assessed 3 months after quit date
7-Day Point Prevalence Smoking Quit Rates 6 Months Post Quit Date
Time Frame: 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.
Assessed 6 months after quit date
7-Day Point Prevalence Smoking Quit Rates 12 Months Post Quit Date
Time Frame: 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.
Assessed 12 months after quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
Howard Brown Health Center

Investigators

  • Principal Investigator: Alicia K Matthews, Ph.D., University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

July 1, 2012

First Posted (ESTIMATE)

July 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-0538
  • R01DA023935 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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