Optimizing Smoking Cessation for People Living with HIV

This study is looking for 500 people living with HIV who smoke to test different ways to help them quit. We are studying four approaches: Motivational Interviewing (counseling to help you find your own reasons to change), Peer Mentoring (support from a former smoker living with HIV), Skills-based Text Messaging (like smokefreeTXT.gov), and Combination Nicotine Replacement Therapy (NRT) (patches to help with nicotine cravings). To join, you must be 18 or older, smoke at least 5 cigarettes a day, test positive for salivary cotinine (a marker of nicotine use), and be receiving HIV care in the greater NYC area. The main goal is to see how many people successfully quit smoking after 32 weeks, confirmed by a test.

Study design
This is an interventional study planning to enroll 500 participants. It uses a Multiphase Optimization Strategy (MOST) to find the best combination of interventions.
What's involved
You would receive six sessions of Motivational Interviewing counseling over 10-12 weeks, eight sessions of Peer Mentoring, and an 8-week text messaging program. You may also receive Nicotine Replacement Therapy patches for 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study is measured at 32 weeks after starting the intervention.

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NCT06598397

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
New York University
~500 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Motivational Interviewing (MI) CounselingPeer MentoringSkills-based Text MessagingCombination NRT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care
Measured over 32 weeks
Human Immunodeficiency Virus (HIV)
Smoking Cessation
1 sites across 1 states
New York1

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Eligibility criteria

Inclusion

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

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
  • Biochemically-validated 7-day point prevalence smoking abstinence among SLWH in HIV clinical care32 weeks

    Self-reported 7-day cigarette PPA (point prevalence abstinence), with biochemical verification of CO (carbon monoxide) ≤6 ppm and negative salivary cotinine