Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Human Immunodeficiency Virus (HIV)
• Intervention / Treatment: Drug: Combination NRT; Behavioral: Skills-based Text Messaging; Behavioral: Peer Mentoring; Behavioral: Motivational Interviewing (MI) Counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jennifer Cantrell, DrPH, MPA; Phone Number: 212-998-5797; Email: jennifer.cantrell@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • New York University School of Global Public Health
      • Contact: Jennifer Cantrell, DrPH, MPA; Phone Number: 212-998-5797; Email: jennifer.cantrell@nyu.edu
      • Contact: Rachel Warshaw, MPH; Phone Number: 23948 212-992-3948; Email: rw1738@nyu.edu
      • Principal Investigator: Jennifer Cantrell, DrPH, MPA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.
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.	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.; 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 7; Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.	Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.; 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 8; Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.	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.; Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.; 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 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.	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.; 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 11; Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.	Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.; 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 12; Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.	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.; Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.; 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 13; Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling 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: 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 14; Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.	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.; 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: 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 15; Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.	Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.; 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: 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 16; Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.	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.; Behavioral: Skills-based Text Messaging; NCI's 8-week text messaging smoking cessation program, smokefreeTXT.gov.; 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: Motivational Interviewing (MI) Counseling; Six sessions of phone counseling over 10-12 weeks with MI counselor trained in motivational interviewing and tobacco use treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care	Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine	32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 30-day PPA	Self-reported 30-day cigarette PPA (point prevalence abstinence)	32 weeks
Self-reported 7-day PPA	Self-reported 7-day cigarette PPA (point prevalence abstinence) with carbon monoxide verification (<=6 ppm)	8 and 16 weeks
Self-reported 30-day PPA	Self-reported 30-day cigarette PPA (point prevalence abstinence)	8 and 16 weeks
Quit attempts	Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment	8, 16, and 32 weeks

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: implementation; multiphase optimization strategy; MOST; HIV clinical care
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Behavior; Health Behavior; Acquired Immunodeficiency Syndrome; Smoking Cessation; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Directive Counseling; Mental Health Services; Motivational Interviewing; Counseling
• Other Study ID Numbers: CA268932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No