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

Phase 4

Recruiting

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

• Registration Number: NCT06598397
• Lead Sponsor: New York University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-10
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Condition 2	Combination NRT	Participants will receive the Core Component and Combination-NRT intervention.
Condition 3	Skills-based Text Messaging	Participants will receive the Core Component and Text Messaging intervention.
Condition 4	Skills-based Text Messaging	Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
Condition 4	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.
Condition 5	Peer Mentoring	Participants will receive the Core Component and Peer Mentoring intervention.
Condition 6	Peer Mentoring	Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
Condition 6	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.
Condition 7	Peer Mentoring	Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
Condition 7	Skills-based Text Messaging	Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.
Condition 8	Peer Mentoring	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
Condition 8	Skills-based Text Messaging	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
Condition 8	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.
Condition 9	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component and Motivational Interviewing Counseling intervention.
Condition 10	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
Condition 10	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.
Condition 11	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
Condition 11	Skills-based Text Messaging	Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.
Condition 12	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
Condition 12	Skills-based Text Messaging	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
Condition 12	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.
Condition 13	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
Condition 13	Peer Mentoring	Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.
Condition 14	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 14	Peer Mentoring	Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 14	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 15	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 15	Peer Mentoring	Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 15	Skills-based Text Messaging	Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.
Condition 16	Motivational Interviewing (MI) Counseling	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
Condition 16	Peer Mentoring	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
Condition 16	Skills-based Text Messaging	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.
Condition 16	Combination NRT	Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.

Primary Outcome Measures

Name	Time	Method
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care	24-32 weeks	Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine assessment

Secondary Outcome Measures

Name	Time	Method
Self-reported 30-day PPA	6-10 and 12-16 weeks	Self-reported 30-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative cotinine assessment
Self-reported 7-day PPA	6-10 and 12-16 weeks	Self-reported 7-day cigarette PPA (point prevalence abstinence)
Quit attempts	6-10, 12-16, and 24-32 weeks	Number of quit attempts (of at least 24 hours) in last 7 days and since last assessment

Trial Locations

Locations (1)

New York University School of Global Public Health; 🇺🇸 New York, New York, United States