Design of a comparative effectiveness evaluation of a culturally tailored versus standard community-based smoking cessation treatment program for LGBT smokers

BACKGROUND: Smoking prevalence rates among the lesbian, gay, bisexual, and transgender (LGBT) population are significantly higher than the general population. However, there is limited research on smoking cessation treatments in this group, particularly on culturally targeted interventions. Moreover, there are few interventions that address culturally specific psychosocial variables (e.g., minority stress) that may influence outcomes. This paper describes the protocol for a comparative effectiveness trial testing an evidence-based smoking cessation program, Courage to Quit, against a culturally tailored version for LGBT smokers, and examines the role of culturally specific psychosocial variables on cessation outcomes. METHODS/DESIGN: To examine the effectiveness of a culturally targeted versus standard smoking cessation intervention, the study utilizes a 2-arm block, randomized, control trial (RCT) design. Adult LGBT participants (n = 400) are randomized to one of the two programs each consisting of a six-session group program delivered in a community center and an eight week supply of the transdermal nicotine patch. Four individualized telephone counseling sessions occur at weeks 2, 5, 7, and 9, at times of greatest risk for relapse. Study outcome measures are collected at baseline, and 1, 3, 6, and 12 months post quit date. Primary outcomes are expired air carbon monoxide verified 7-day point-prevalence quit rates at each measurement period. Secondary outcomes assess changes in cravings, withdrawal symptoms, smoking cessation self-efficacy, and treatment adherence. Additionally, study staff examines the role of culturally specific psychosocial variables on cessation outcomes using path analysis. DISCUSSION: Determining the efficacy of culturally specific versus standard evidence based approaches to smoking cessation is a critical issue facing the field today. This study provides a model for the development and implementation of a culturally tailored smoking cessation intervention for LGBT participants and addresses a gap in the field by examining the role of culturally psychosocial variables associated with cessation outcomes. TRIAL REGISTRATION: U.S. National Institutes of Health Clinical Trials NCT01633567 Registered 30 May 2012.