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

Last updated: June 4, 2025
Sponsor: New York University
Overall Status: Active - Recruiting

Phase

4

Condition

Smoking Cessation

Sexually Transmitted Diseases (Stds)

Hiv (Pediatric)

Treatment

Motivational Interviewing (MI) Counseling

Peer Mentoring

Combination NRT

Clinical Study ID

NCT06598397
CA268932
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Suffers from any medical condition or contraindication precluding use of nicotinereplacement therapy

  • Current use of any tobacco cessation medications (varenicline, NRT patch, nicotinegum, 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

Total Participants: 500
Treatment Group(s): 4
Primary Treatment: Motivational Interviewing (MI) Counseling
Phase: 4
Study Start date:
October 18, 2024
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • New York University School of Global Public Health

    New York, New York 10003
    United States

    Active - Recruiting

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