Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06598397

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

Led by New York University · Updated on 2026-04-13

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

New York University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying smokers living with HIV (SLWH) to find the most effective, affordable, and easy-to-use smoking cessation program that can be integrated into HIV clinical care. The study uses the Multiphase Optimization Strategy (MOST) to address both patient and clinical barriers to quitting smoking, aiming to improve quitting rates while minimizing cost and staff burden. This research focuses on combining different interventions proven helpful but not yet optimized for this group. Participants may receive various combinations of four key interventions including Motivational Interviewing counseling via phone, Peer Mentoring by experienced former smokers living with HIV, Skills-based Text Messaging through an 8-week program, and Combination Nicotine Replacement Therapy (NRT) with patches and lozenges tailored to smoking levels. Every participant receives a Core Component, and the study tests different intervention combinations to find the best mix for broad use in HIV care settings. During the study, participants will be monitored up to 32 weeks with assessments including biochemically-validated smoking abstinence and self-reported quit attempts. Researchers will evaluate how well participants follow the program, how acceptable and feasible the interventions are, and the overall cost-effectiveness. The study includes regular check-ins and will use data to identify the best sustainable smoking cessation package that can be scaled within HIV clinical care environments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Status as HIV positive
  • Age 18 or older
  • Currently smokes 5 or more cigarettes per day on average in the past month
  • Positive for salivary cotinine
  • Able to understand the study and consent process
  • Engaged in HIV clinical care
  • Living in the larger NYC metropolitan area currently and for the next 6 to 8 months
Not Eligible

You will not qualify if you...

  • Medical conditions or reasons that prevent use of nicotine replacement therapy
  • Current use of tobacco cessation medications (varenicline, NRT patch, gum, lozenge, spray, inhaler, or bupropion)
  • Currently participating in a smoking cessation program
  • Pregnant or nursing and plans to be so in the next 6 months
  • Has schizophrenia or schizo-affective disorder
  • Does not have a working mobile phone that can receive text messages

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 to 12 weeks

Participants receive behavioral interventions including Motivational Interviewing counseling, Peer Mentoring, and Skills-based Text Messaging, as well as combination nicotine replacement therapy as appropriate based on smoking level.

Multiple counseling sessions and text messaging over treatment period

Follow-up

Duration - Up to 20 weeks following treatment

Participants are assessed for smoking abstinence and quit attempts after the treatment period to evaluate the effectiveness of the interventions.

Follow-up assessments at 8, 16, and 32 weeks

Trial Site Locations

Total: 1 location

1

New York University School of Global Public Health

New York, New York, United States, 10003

Actively Recruiting

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Research Team

J

Jennifer Cantrell, DrPH, MPA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

16

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