Clinical trial NCT05413265: Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation
Official title: Alaska Native Family-Based, Financial Incentives Intervention for Smoking Cessation: Phases 1 and 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Alaska Native
Smoking Cessation
Family
Financial Incentive
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Alaska Native Tribal Health Consortium
First posted: 2022-06-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the proposed study is to develop and beta-test a culturally adapted, Alaska Native family-based incentives intervention for smoking cessation.

Detailed description: Aim 1 has two 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 negative, completed smoking status checks. A negative check-in counts as self-reported abstinence and biochemically confirmed abstinence: saliva cotinine sample measuring ≤ 30 n/ml (negative Alere iScreen result) and expired carbon monoxide sample measuring ≤ 6 ppm with iCOQuit device.

Eligibility criteria: 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 ≥ 18 years (legal smoking age in Alaska).
* Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 n/ml (positive Alere iScreen result) for Phase 2.
* 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.
* Smokes marijuana at least once a week and not willing to quit for study (interferes with breath test) in Phase 2

Family Member Participants, regardless of smoking status or residence with the index participant, will be eligible if they:

* Are ≥ 18 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.

Alaska Tribal Health System stakeholders (Phase 1 only):

- 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.

Primary outcomes:
measure: Change in smoking status
timeFrame: 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christi A Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.
citation: Sinicrope PS, Tranby BN, Young AM, Koller KR, King DK, Lee FR, Sabaque CV, Prochaska JJ, Borah BJ, Decker PA, McDonell MG, Stillwater B, Thomas TK, Patten CA. Adapting a Financial Incentives Intervention for Smoking Cessation With Alaska Native Families: Phase 1 Qualitative Research to Inform the Aniqsaaq (To Breathe) Study. Nicotine Tob Res. 2024 Sep 23;26(10):1377-1384. doi: 10.1093/ntr/ntae092.