Path2Quit Tobacco Intervention For African Americans

Study Overview
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Brief Summary
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The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program. The study includes completing surveys and receiving text messages to help participants become tobacco free.

Detailed Description
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OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format. Specific Aim 2: Conduct a pilot study of the video-text intervention. Study Design: 2-arm semi-pragmatic randomized design among current tobacco users Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.

Official Title
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Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans

Conditions
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Smoking Cessation, Smoking, Tobacco

Intervention / Treatment
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* Behavioral: SmokeFreeText
* Behavioral: Path2Quit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identify as African American Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days. Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines Exclusion Criteria: Does not meet all of the above inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will conduct a 2-arm semi-pragmatic randomized design among current tobacco users (N=100). CMHA residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Path2Quit<br>Culturally specific text message intervention | Behavioral: Path2Quit<br>* Path2Quit will deliver 20-60 second video clips by multimedia messaging service. The message library will include 75-170 messages. Written text messages will be limited to brief phrases to indicate the topic of the video. Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime. The cultural adaptations will be infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.<br>|
| Active Comparator: SmokeFreeText<br>The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation | Behavioral: SmokeFreeText<br>* SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention. The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov or by texting QUIT to short code 47848. Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date. Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status). The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time. When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system. Participants can opt-out by texting STOP at any time. With informed consent, we will be able to access the SmokefreeTXT data for these participants.<br>* Other names: SmokefreeTXT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who abstain from smoking | Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach | At 1-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of missed nicotine replacement therapy doses | Measure of NRT adherence. Number of missed doses will be recorded for each participant | Up to 1-month follow-up | 
| 24-Hour quit attempts | Number of times a participant quits smoking for at least 24 hours | At 1-month follow-up | 
| Changes in carbon monoxide breath levels from baseline to followup | Breath carbon monoxide tests will biochemically confirm self-reported cessation | At 1-month follow-up | 
| Changes in Contemplation ladder score | self-reported score 0-10 where a higher score indicates more readiness to quit | From baseline to up to 1-month follow-up | 
| Average score of Intervention Evaluation (IRQ) | The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction | At 1-month follow-up | 
| Average score of smoking urges | This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement | Up to 1-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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culturally specific