Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Study Overview
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Brief Summary
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The objective of the proposed study is to evaluate the effectiveness and implementation of a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation.

Detailed Description
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We will conduct the research in three phases. In Aim 1/Phase 1, we will use qualitative in-depth individual interviews to culturally tailor and adapt the intervention. These interviews (n=36) will include Alaska Native or American Indian (AN/AI) people who smoke (n=12), family members of Alaska Native people who smoke (n=12), and stakeholders from the Alaska Tribal Health System (n=12). We will present the proposed financial incentives intervention to each group and ask them questions about possible concerns, recruitment strategies, possible risks, and appeal to Alaska Native culture. For the stakeholders, we will also ask about potential barriers of implementing the program into their organization/department. In Aim 1/Phase 2, we will beta-test and refine the intervention with 10 dyads comprising of an AN/AI person who smokes and their family member. The beta-test will last for 6 months. The dyad will receive cash rewards of increasing value over the course of the 6 months for completing smoking status checks. In Aims 2 and 3/Phase 3, we will conduct an RCT and evaluate intervention effectiveness and implementation. The RCT will include 656 dyads of AN/AI people who smoke and their family member.

Official Title
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Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Written cessation & support materials
* Other: Financial Incentive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Index Participants will be eligible if they: Are an ANAI person (based on self-reported race/ethnicity) and reside in Alaska. Are aged ≥ 21 years (legal smoking age in Alaska). Self-report smoking in the past 7 days, biochemically verified with breath expired air carbon monoxide (CO) ≥ 4 ppm and saliva cotinine ≥ 30 n/ml (positive Alere iScreen result). Smoked ≥ 3 cigarettes per day (cpd) over the past 3 months. If other tobacco or nicotine product used, cigarettes are the main tobacco product used. Are considering or willing to make a quit attempt. Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad mini for the study duration. Nominate one adult family member who will enroll. Index Participants Exclusion Criteria: Used pharmacotherapy or a stop smoking program within the past 3 months. Another person in the household is enrolled as the index participant. Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they: Are ≥ 21 years old. Are defined as family by the index participant. Own or have access to a mobile phone or tablet with internet and text messaging capabilities or will be loaned an iPad mini for the study duration. Both men and women and those from non-ANAI racial/ethnic groups. Family members may only support one index participant to mitigate concern about lack of independence of household or other support networks, and potential for cross treatment contamination, which could attenuate effects in the RCT. Alaska Tribal Health System stakeholders: - Input from healthcare providers, cessation specialists, and THO leaders will be gathered to understand potential facilitators and barriers to adoption of the intervention within the ATHS. The ANTHC team will invite individuals to participate through phone and email communications.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incentives intervention condition<br>Subjects will receive generic, existing resources and referral information on evidence-based tobacco/nicotine cessation treatment services including the Alaska quitline, regional Tribal cessation programs, and smokefree.gov services and Alaska Native Tribal Health Consortium (ANTHC) family wellness resources on general health topics (e.g., injury prevention, household air quality) that include regional links to programs for domestic violence. Subjects will additionally receive individual cash card rewards for achieving biochemically verified smoking abstinence at each time point. | Other: Written cessation & support materials<br>* Resources and referral information on evidence-based tobacco/nicotine cessation treatment services<br>Other: Financial Incentive<br>* Cash rewards for achieving biochemically verified smoking abstinence at each time point<br>|
| Active Comparator: No incentives control condition<br>Subjects will receive generic, existing resources and referral information on evidence-based tobacco/nicotine cessation treatment services including the Alaska quitline, regional Tribal cessation programs, and smokefree.gov services and ANTHC family wellness resources on general health topics (e.g., injury prevention, household air quality) that include regional links to programs for domestic violence. | Other: Written cessation & support materials<br>* Resources and referral information on evidence-based tobacco/nicotine cessation treatment services<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in smoking status | Number of participants to have biochemically confirmed, prolonged smoking abstinence | 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alaska Native, Smoking Cessation, Family, Financial Incentive