Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT06556433
Eligibility Criteria:
Index Participant Inclusion Criteria:
* Alaska Native/American Indian (ANAI) person (based on self-reported race) and reside in Alaska.
* Age ≥18 years.
* Self-report smoking in the past 7 days, biochemically verified with saliva cotinine ≥ 30 ng/mL (positive result based on at-home saliva swab test provided by study team).
* Smoked ≥ 3 cigarettes per day over the past 3 months.
* Considering or willing to make a quit attempt.
* Have or will nominate one adult family member to enroll with them.
* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration
* Willing to upload photos of self during completion of smoking status tests.
* Willing to complete and sign an Internal Revenue Service (IRS) W-9 tax identification form if they wish to receive payments on the study.
* Willing to provide written informed consent and participate in study-related tests and procedures.
Index Participant Exclusion Criteria:
* Used pharmacotherapy or a stop smoking program within the past 3 months.
* Already enrolled in the study with another family member.
* Self-report current marijuana smoking more than once per week and are not willing to quit for the study duration (interferes with breath test).
* Participated in a prior study phase.
Family Member Participant Inclusion Criteria (regardless of smoking status or residence with the index participant):
* Age ≥18 years.
* Defined as family and nominated by the index participant, or have an ANAI family member who is ≥18 years and smokes that they would like to support in quitting.
* Own or have access to a mobile phone or tablet with Internet and text messaging capabilities, or will be loaned an iPad for the study duration.
* Willing to complete and sign an IRS W-9 tax identification form if they wish to receive payments on the study.
* Willing to provide written informed consent and participate in study related tests and procedures.
Both men and women, those from non-ANAI racial/ethnic groups, and those who live outside of Alaska in the United States will be eligible family member participants.
Family Member Participant Exclusion Criteria:
* Already enrolled with another family member.
* Participated in a prior study phase.
After the randomized controlled trial, qualitative interviews will be conducted with index participants, family member participants, and Alaska Tribal Health System Stakeholders to inform program implementation. Healthcare providers, cessation specialists, Elder advisors, and Tribal Health System leaders and stakeholders will be invited by the Alaska Native Tribal Health Consortium team and separately consented and interviewed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06556433
Study Brief:
Protocol Section:
NCT06556433