Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
NCT ID: NCT06598397
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2024-10-18
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Condition 1
Participants will receive the Core Component.
No interventions assigned to this group
Condition 2
Participants will receive the Core Component and Combination-NRT intervention.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 3
Participants will receive the Core Component and Text Messaging intervention.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Condition 4
Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 5
Participants will receive the Core Component and Peer Mentoring intervention.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Condition 6
Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 7
Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Condition 8
Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 9
Participants will receive the Core Component and Motivational Interviewing Counseling intervention.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Condition 10
Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 11
Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Condition 12
Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 13
Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Condition 14
Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Condition 15
Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Condition 16
Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Interventions
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Motivational Interviewing (MI) Counseling
Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Peer Mentoring
Eight sessions of informal counseling with an experienced peer former smoker living with HIV to model healthy behavior and provide practical advice and tips for quitting based on their lived experience.
Skills-based Text Messaging
NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Combination NRT
If they smoke 10 or more cigarettes per day (CPD), participants will receive 2 weeks of 21 mg patches, 2 weeks of 14 mg patches and 2 weeks of 7 mg patches; if they smoke less than 10 CPD, participants will receive 4 weeks of 14 mg patches and 2 weeks of 7 mg patches. Participants will receive either 2 or 4 mg of nicotine lozenges for a total of up to 20 lozenges per day.
Eligibility Criteria
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Inclusion Criteria
* Age 18 or older
* Currently smokes ≥ 5 CPD, on average, in past month
* Positive for salivary cotinine
* Able to understand the nature of the study and the consenting process
* Is engaged in HIV clinical care
* Living in larger NYC metropolitan area currently and for the next 6-8 months
Exclusion Criteria
* Current use of any tobacco cessation medications (varenicline, NRT patch, nicotine gum, lozenge, spray or inhaler, or bupropion)
* Currently participating in a smoking cessation program
* Pregnant or nursing and plans to be in next 6 months
* Has schizophrenia/schizo-affective disorder
* Does not have a functioning mobile phone that can receive text messages
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
New York University
OTHER
Responsible Party
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Locations
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New York University School of Global Public Health
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CA268932
Identifier Type: -
Identifier Source: org_study_id
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