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Trial record 18 of 1368 for:    rural

Smoking Cessation Tailored to Rural Young Adult African American Men:

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ClinicalTrials.gov Identifier: NCT03808714
Recruitment Status : Active, not recruiting
First Posted : January 17, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Isabel Scarinci, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: TOUCHDOWN Behavioral: Control Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Development, Implementation, and Evaluation of a Smoking Cessation Tailored to Rural Young Adult African American Men: Toward Scalability
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cessation [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   African American men between the ages of 18 and 30 living in the participating rural counties
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808714


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Isabel C Scarinci, PhD University of Alabama at Birmingham
Principal Investigator: William Carroll, MD University of Alabama at Birmingham

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Responsible Party: Isabel Scarinci, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03808714     History of Changes
Other Study ID Numbers: IRB-160204003
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabel Scarinci, University of Alabama at Birmingham:
african american, smoking cessation, rural, young adults