Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Study Overview
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Brief Summary
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The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.

Detailed Description
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Using content and strategy developed from the formative research phase, this randomized smoking cessation trial will test the impact of a tailored cessation intervention for socioeconomically-disadvantaged young adult (SDYA) smokers compared to a usual-care control on intervention engagement, self-efficacy to quit, and 30-day point prevalence abstinence at 3-month follow-up. This study will take place over a 3-month period. Individuals who complete the screening survey and are eligible to participate will be asked to complete a 15-20 minute baseline survey at the start of the study. This survey will ask questions about use of mobile phones, tobacco use, recent alcohol and other drug use, concerns about the coronavirus outbreak and how it may affect personal tobacco use, and physical activity. After the first survey, participants will be assigned randomly to one of two study groups: Group A: Referral to a quit smoking hotline (quit line) Group B: Referral to a quit smoking hotline (quit line), plus enrollment in a web and text-based smoking cessation intervention. Participants in both groups will be enrolled after completing the following steps, in order: Providing consent to participate in the study; Confirming contact information; Completing a payment acknowledgement form that allows us to reimburse for survey/task completions; and Completing the baseline survey. To complete enrollment, participants in Group B will also be required to register for an account on BecomeAnEx.org and enroll in text messages on the site. Once registered, Group B participants will be enrolled in a text message program customized for this study and will need to respond to the initial message from the text message platform to initiate text messages. Participants in Group B will receive daily text messages for 3 months with content delivered through the Truth Initiative's BecomeAnEx digital quit smoking platform. They will also receive brief (1-2 minute) weekly check-in surveys related to the week's messages and smoking status during this time. At 3-months, participants in both groups will receive the 15-minute follow-up assessment. Participants in both groups who report quitting smoking at 3-months will be mailed a kit in order to take a saliva test to measure the amount of cotinine, a metabolite of nicotine, in their saliva. Participants who report smoking at the 3-month follow-up will not receive this saliva test. All study procedures will take place remotely, with surveys conducted online. Participants in Group A will be paid at least $30 for participation and up to $80. Participants in Group B will be paid at least $40 for participation and up to $170.

Official Title
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Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

Conditions
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Nicotine Dependence, Cigarettes

Intervention / Treatment
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* Behavioral: Web + text smoking cessation intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-30 lives in the U.S. smoked at least 100 lifetime cigarettes currently smokes every day or some days interest in quitting smoking within the next 6 months subjective financial situation of just meeting or not meeting basic expenses access to a smartphone with internet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web + text smoking cessation intervention<br>Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention | Behavioral: Web + text smoking cessation intervention<br>* Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention<br>|
| No Intervention: Usual care control<br>Participants will receive referral to a quit smoking hotline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day point prevalence smoking abstinence | Self-reported smoking abstinence and biochemical validation (saliva cotinine) | Assessed at 3-month follow-up | 
| Self-efficacy to quit smoking | Confidence to quit within the next month (7days) on 0-10 scale | Assessed at 3-month follow-up | 
| Intervention engagement | Completing 75% or more of 12 weekly check-ins | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence smoking abstinence | Self-reported smoking abstinence | Assessed at 3-month follow-up | 
| Number of 24-hour quit attempts | Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit | Assessed at 3-month follow-up | 
| Perceived support to quit smoking | 4 items pertaining to quit support from the text messages | Assessed 3-month follow-up | 
| Pattern and rate of tobacco/e-cigarette use | Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products | Assessed at 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, smoking cessation, nicotine, nicotine dependence