Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Optimizing a smoking cessation program for people living with HIV

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

Run by New York University · NCT06598397 · Data updated 2026-11-12

This study is trying to find the best way to help people living with HIV quit smoking by using a mix of support methods like counseling, mentoring, and text reminders.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorNew York University
Academic / other
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 18, 2024
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedApril 13, 2026
Trial IDNCT06598397 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are HIV-positive individuals aged 18 or older who smoke at least 5 cigarettes per day and are engaged in HIV clinical care.

Probably not a fit

Patients who are currently using tobacco cessation medications or participating in other smoking cessation programs may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance smoking cessation outcomes for smokers living with HIV by implementing a multiphase optimization strategy (MOST) that addresses both patient and clinical care barriers. The intervention includes components such as Motivational Interviewing, Peer Mentoring, Text Messaging, and Combination Nicotine Replacement Therapy, which have shown potential but are underutilized. The study will evaluate the effectiveness, acceptability, and feasibility of these interventions within HIV clinical care settings to develop a cost-effective and scalable smoking cessation package. By targeting a diverse population of smokers living with HIV, the study seeks to improve overall health outcomes and reduce smoking rates in this vulnerable group.

Why it matters

Potential benefit: If successful, this study could significantly improve smoking cessation rates among smokers living with HIV, leading to better health outcomes.

How similar studies have gone: While components of the intervention have shown promise in previous research, this specific optimization approach has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • New York University School of Global Public Health
    New York, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.