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

New York University (NYU)

Status and phase: Enrolling; Phase 4

Conditions: Human Immunodeficiency Virus (HIV); Smoking Cessation

Treatments: Behavioral: Peer Mentoring; Behavioral: Skills-based Text Messaging; Drug: Combination NRT; Behavioral: Motivational Interviewing (MI) Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06598397

CA268932

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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500 participants in 16 patient groups

Condition 1

No Intervention group

Description:

Participants will receive the Core Component.

Condition 2

Experimental group

Description:

Participants will receive the Core Component and Combination-NRT intervention.

Treatment:

Drug: Combination NRT

Condition 3

Experimental group

Description:

Participants will receive the Core Component and Text Messaging intervention.

Treatment:

Behavioral: Skills-based Text Messaging

Condition 4

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT and Text Messaging interventions.

Treatment:

Drug: Combination NRT

Behavioral: Skills-based Text Messaging

Condition 5

Experimental group

Description:

Participants will receive the Core Component and Peer Mentoring intervention.

Treatment:

Behavioral: Peer Mentoring

Condition 6

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT and Peer Mentoring interventions.

Treatment:

Drug: Combination NRT

Behavioral: Peer Mentoring

Condition 7

Experimental group

Description:

Participants will receive the Core Component as well as the Text Messaging and Peer Mentoring interventions.

Treatment:

Behavioral: Skills-based Text Messaging

Behavioral: Peer Mentoring

Condition 8

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Peer Mentoring interventions.

Treatment:

Drug: Combination NRT

Behavioral: Skills-based Text Messaging

Behavioral: Peer Mentoring

Condition 9

Experimental group

Description:

Participants will receive the Core Component and Motivational Interviewing Counseling intervention.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Condition 10

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Drug: Combination NRT

Condition 11

Experimental group

Description:

Participants will receive the Core Component as well as the Text Messaging and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Behavioral: Skills-based Text Messaging

Condition 12

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Drug: Combination NRT

Behavioral: Skills-based Text Messaging

Condition 13

Experimental group

Description:

Participants will receive the Core Component as well as the Peer Mentoring and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Behavioral: Peer Mentoring

Condition 14

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT, Peer Mentoring and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Drug: Combination NRT

Behavioral: Peer Mentoring

Condition 15

Experimental group

Description:

Participants will receive the Core Component as well as the Text Messaging, Peer Mentoring and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Behavioral: Skills-based Text Messaging

Behavioral: Peer Mentoring

Condition 16

Experimental group

Description:

Participants will receive the Core Component as well as the Combination-NRT, Text Messaging, Peer Mentoring, and Motivational Interview Counseling interventions.

Treatment:

Behavioral: Motivational Interviewing (MI) Counseling

Drug: Combination NRT

Behavioral: Skills-based Text Messaging

Behavioral: Peer Mentoring