NCT06598397

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Immunodeficiency Virus (HIV)
• Smoking Cessation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-18
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2024-09-19
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study