Smoking Cessation Tailored to Rural Young Adult African American Men:

Study Overview
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Brief Summary
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Our preliminary data shows that 39.9% of AA men between 19 and 30 years of age who resided in rural Alabama smoke cigarettes. Although it has been well established that a combination of pharmacotherapy and advice-oriented counseling and/or cognitive behavioral interventions are efficacious in promoting smoking cessation across diverse populations, these evidence-based treatments for tobacco dependence have not proven to be effective/efficacious (or even accessible) among some subpopulations suffering disproportionally from tobacco-related morbidity and mortality. The overall goal of this feasibility study is to make adaptations to these evidence-based approaches, and develop, implement, and examine the feasibility and scalability of a theory-based, culturally relevant smoking cessation intervention for young adult AA men in rural Alabama who smoke cigarettes. Our formative assessments point to a cognitive-behavioral intervention delivered by a trained Community Health Worker with the support from an expert physician who can deliver the pharmacological component via Skype through an integrated approach. The proposed study will address the next three steps in this process: development of the intervention, pretesting, and feasibility. First, we will develop the intervention with input from a Community Advisory Committee, followed by an iterative process by which the target audience will be exposed to materials and messages to provide feedback (pretesting). Once all intervention components are finalized, we will recruit participants, randomly assign them to intervention/control groups, pilot test, and evaluate the intervention. The comparison group will be the Alabama Tobacco Quitline with 8 weeks of Nicotine Replacement Therapy to be consistent with the pharmacological approach proposed for the intervention. The primary outcome will be 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.

Detailed Description
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Despite smoking fewer cigarettes daily, African American (AA) men suffer higher morbidity and mortality associated with tobacco-related disorders than whites. Our preliminary data shows that 39.9% of AA men between 19 and 30 years of age who resided in rural Alabama smoke cigarettes. Although it has been well established that a combination of pharmacotherapy and advice-oriented counseling and/or cognitive behavioral interventions are efficacious in promoting smoking cessation across diverse populations, these evidence-based treatments for tobacco dependence have not proven to be effective/efficacious (or even accessible) among some subpopulations suffering disproportionally from tobacco-related morbidity and mortality. The overall goal of this feasibility study is to make adaptations to these evidence-based approaches, and develop, implement, and examine the feasibility and scalability of a theory-based, culturally relevant smoking cessation intervention for young adult AA men in rural Alabama who smoke cigarettes. Our formative assessments point to a cognitive-behavioral intervention delivered by a trained Community Health Worker with the support from an expert physician who can deliver the pharmacological component via Skype through an integrated approach. The proposed study will address the next three steps in this process: development of the intervention, pretesting, and feasibility. First, we will develop the intervention with input from a Community Advisory Committee, followed by an iterative process by which the target audience will be exposed to materials and messages to provide feedback (pretesting). Once all intervention components are finalized, we will recruit participants, randomly assign them to intervention/control groups, pilot test, and evaluate the intervention. The comparison group will be the Alabama Tobacco Quitline with 8 weeks of Nicotine Replacement Therapy to be consistent with the pharmacological approach proposed for the intervention. The primary outcome will be 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.

Official Title
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Development, Implementation, and Evaluation of a Smoking Cessation Tailored to Rural Young Adult African American Men: Toward Scalability

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: TOUCHDOWN
* Behavioral: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a) African American; (b) men; (c) between the ages of 18 and 30; (d) residing in Sumter and Greene counties; and (e) smoked cigarettes within the past seven days. For the feasibility testing of the intervention, participants must have a permanent residence in the county and no intent to move within the next 12 months. Exclusion Criteria: Recent MI and unstable angina.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention - smoking cessation program delivered by Community Health Worker with pharmacological support by a specialist at the university Control - Alabama Quitline
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>We expect the intervention to consist of 3 to 4 group sessions and at least one individual session (delivered by a trained Community Health Worker) plus pharmacological consultation(s) via telemedicine, but this will be determined during pretesting. | Behavioral: TOUCHDOWN<br>* We expect the intervention to consist of 3 to 4 group sessions and at least one individual session plus pharmacological consultation(s) via Skype, but this will be determined during pretesting. CHWs will have IPads with cellular connectivity and will be present when the pharmacological approach is discussed with the participant so that they can reinforce the message with the participant and be the liaisons between the participant and physician.<br>|
| Active Comparator: Control<br>Alabama Tobacco Quitline, which is considered the standard-of-care for smoking cessation in Alabama. | Behavioral: Control Group<br>* Alabama Quitline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation | The primary outcome will be a 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days and verified through measurement of exhaled carbon monoxide levels) at 6-month follow-up. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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african american, smoking cessation, rural, young adults