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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03808714
Enrollment
35
Registered
2019-01-17
Start date
2016-04-26
Completion date
2020-08-01
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

african american, smoking cessation, rural, young adults

Brief summary

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

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.

Interventions

BEHAVIORALTOUCHDOWN

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.

BEHAVIORALControl Group

Alabama Quitline

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Intervention - smoking cessation program delivered by Community Health Worker with pharmacological support by a specialist at the university Control - Alabama Quitline

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cessation6 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026