Enhancing Smoking Cessation for African American People Everywhere
NCT ID: NCT07024992
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2025-10-01
2029-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ESCAPE intervention + NRT
ESCAPE app + NRT
ESCAPE is a mobile intervention that targets anxiety sensitivity among Black adults who smoke cigarettes and have HIV. This intervention is framed within the cultural context of interoceptive stress among Black adults who smoke, which is supported by theory, empirical evidence, and characteristics of this group. The intervention employs a variety of features to educate users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. ESCAPE also utilizes Ecological Momentary Assessments (EMAs) to gather information and provide personalized messages to users in real time. All participants will receive free nicotine replacement therapy (NRT).
quitSTART intervention + NRT
quiSTART app + NRT
quitSTART is a smartphone-based National Cancer Institute (NCI) intervention for standard mobile smoking cessation treatment. The intervention contains features that allow its' users to better understand their smoking patterns, and build skills needed to become and stay smoke free. The app allows users to track cravings and delivers motivational messages to users for each craving they track. All participants will receive free nicotine replacement therapy (NRT).
Control (CTRL)
Control (CTRL)
The CTRL group will complete the same baseline survey, follow-up surveys, and ecological momentary assessments as the ESCAPE app + NRT and the quitSTART app + NRT group. All participants will receive free nicotine replacement therapy (NRT). They will not receive additional intervention content.
Interventions
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ESCAPE app + NRT
ESCAPE is a mobile intervention that targets anxiety sensitivity among Black adults who smoke cigarettes and have HIV. This intervention is framed within the cultural context of interoceptive stress among Black adults who smoke, which is supported by theory, empirical evidence, and characteristics of this group. The intervention employs a variety of features to educate users on how to deal with stress, anxiety, and nicotine withdrawal symptoms. The app contains a series of on-demand features, including a coping toolkit, stress management trainings, and a series of educational videos. ESCAPE also utilizes Ecological Momentary Assessments (EMAs) to gather information and provide personalized messages to users in real time. All participants will receive free nicotine replacement therapy (NRT).
quiSTART app + NRT
quitSTART is a smartphone-based National Cancer Institute (NCI) intervention for standard mobile smoking cessation treatment. The intervention contains features that allow its' users to better understand their smoking patterns, and build skills needed to become and stay smoke free. The app allows users to track cravings and delivers motivational messages to users for each craving they track. All participants will receive free nicotine replacement therapy (NRT).
Control (CTRL)
The CTRL group will complete the same baseline survey, follow-up surveys, and ecological momentary assessments as the ESCAPE app + NRT and the quitSTART app + NRT group. All participants will receive free nicotine replacement therapy (NRT). They will not receive additional intervention content.
Eligibility Criteria
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Inclusion Criteria
* Identify as Black/African American
* Living with HIV
* Willing and able to complete study assessments
* Smoking at least 5 cigarettes per day for at least a year
* Motivated to quit smoking (≥ 5 on a 10-point scale)
* Must be ready to quit cigarettes within 14 days of full enrollment
* Moderate or higher anxiety sensitivity (i.e., ≥ 5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]) OR elevated anxiety (i.e., \> 7 on the Overall Anxiety Severity and Impairment Scale \[OASIS\]) OR depression (i.e., \> 7 on the Overall Depression Severity and Impairment Scale \[ODSIS\])
* Must be interested in using a mobile app
* Must be willing to download a mobile app onto their personal phone
* Must be willing to use NRT
* Possess an Android/Apple smartphone that is compatible with the mobile app
* Demonstrate 7th grade level proficiency in English (\> 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form \[REALM-SF\])
* Valid proof of identification (photo of valid US ID)
Exclusion Criteria
* Not being fluent in English
* High blood pressure that is not under control
* Having experienced a heart attack within the past 2 weeks
* Pregnant of planning to become pregnant within the next six months
* Cognitive impairment (a score of \> 8 on the Six-Item Cognitive Impairment Test \[6-CIT\])
* Residing in a location (Urban/Rural) for which the corresponding study cell has been filled
18 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
University of Houston
OTHER
Responsible Party
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Lorra Garey
Research Associate Professor
Principal Investigators
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Michael S. Businelle, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma Health Sciences
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00004985
Identifier Type: -
Identifier Source: org_study_id
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