Smoking Cessation Tailored to Rural Young Adult African American Men:

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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: TOUCHDOWN; Behavioral: Control Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention; 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; 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.
ACTIVE_COMPARATOR: Control; Alabama Tobacco Quitline, which is considered the "standard-of-care" for smoking cessation in Alabama.	Behavioral: Control Group; Alabama Quitline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2016
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (ACTUAL): January 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: african american, smoking cessation, rural, young adults
• Other Study ID Numbers: IRB-160204003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No