Smoking Cessation Tailored to Rural Young Adult African American Men:
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03808714|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2019
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: TOUCHDOWN Behavioral: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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)|
|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|
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.
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
- 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.
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Isabel C Scarinci, PhD||University of Alabama at Birmingham|
|Principal Investigator:||William Carroll, MD||University of Alabama at Birmingham|