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Purpose

This study's long-term goal is to improve clinical outcomes among smokers living with HIV (SLWH) by providing smoking cessation interventions in HIV clinical care that will increase the chances of quitting smoking, limits costs and burden on staff and reach many smokers living with HIV.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Status as HIV+ - 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

  • Suffers from any medical condition or contraindication precluding use of nicotine replacement therapy - 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
A full factorial randomized controlled trial using Multiphase Optimization STrategy (MOST) with 4 component interventions, each at 2 levels (off/on), for a total of 16 component conditions.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Condition 1 		Participants will receive the Core Component.
Experimental
Condition 2 		Participants will receive the Core Component and Combination-NRT intervention.
  • Drug: 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.
Experimental
Condition 3 		Participants will receive the Core Component and Text Messaging intervention.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Experimental
Condition 4 		Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
  • Drug: 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.
Experimental
Condition 5 		Participants will receive the Core Component and Peer Mentoring intervention.
  • Behavioral: 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.
Experimental
Condition 6 		Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
  • Behavioral: 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.
  • Drug: 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.
Experimental
Condition 7 		Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
  • Behavioral: 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.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Experimental
Condition 8 		Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
  • Behavioral: 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.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
  • Drug: 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.
Experimental
Condition 9 		Participants will receive the Core Component and Motivational Interviewing Counseling intervention.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
Experimental
Condition 10 		Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Drug: 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.
Experimental
Condition 11 		Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Experimental
Condition 12 		Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
  • Drug: 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.
Experimental
Condition 13 		Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Behavioral: 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.
Experimental
Condition 14 		Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Behavioral: 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.
  • Drug: 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.
Experimental
Condition 15 		Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Behavioral: 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.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
Experimental
Condition 16 		Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
  • Behavioral: Motivational Interviewing (MI) Counseling
    Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.
  • Behavioral: 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.
  • Behavioral: Skills-based Text Messaging
    NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
  • Drug: 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.

Recruiting Locations

New York University School of Global Public Health
New York 5128581, New York 5128638 10003
Contact:
Jennifer Cantrell, DrPH, MPA
212-998-5797
jennifer.cantrell@nyu.edu

More Details

Status
Recruiting
Sponsor
New York University

Study Contact

Jennifer Cantrell, DrPH, MPA
212-998-5797
jennifer.cantrell@nyu.edu

Detailed Description

This study will utilize Multiphase Optimization Strategy (MOST) to optimize a smoking cessation treatment for HIV clinical care by directly targeting patient barriers to quitting and clinical care barriers to reaching and effectively treating a broad heterogeneous population of smokers living with HIV. The four intervention components will be aimed at barriers to quitting among smokers living with HIV and include Motivational Interviewing; Peer Mentoring; Text-messaging; Combination Nicotine Replacement Therapy. These components have shown promise in research but are under-utilized to help smokers living with HIV quit and have not been tested in an optimization trial. This study will also incorporate data to evaluate the fidelity, acceptability and feasibility of the interventions in the HIV clinical care context in order to identify the most cost-effective, sustainable and scalable tobacco treatment package for the care environment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.