Optimizing a smoking cessation program for people living with HIV

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

Phase 4 Interventional New York University · NCT06598397

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
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorNew York University Academic / other
Locations1 site (New York, New York)
Trial IDNCT06598397 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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

Eligibility criteria

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 this trial is running

New York, New York

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Human Immunodeficiency VirusSmoking CessationMOSTmultiphase optimization strategyimplementationHIV clinical care
Last reviewed 2026-06-13 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.