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Recruiting Phase 4 NCT06598397

NCT06598397 Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

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Clinical Trial Summary
NCT ID NCT06598397
Status Recruiting
Phase Phase 4
Sponsor New York University
Condition Human Immunodeficiency Virus (HIV)
Study Type INTERVENTIONAL
Enrollment 500 participants
Start Date 2024-10-18
Primary Completion 2028-06-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Motivational Interviewing (MI) CounselingPeer MentoringSkills-based Text Messaging

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 500 participants in total. It began in 2024-10-18 with a primary completion date of 2028-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Jennifer Cantrell, DrPH, MPA

✉ jennifer.cantrell@nyu.edu

📞 212-998-5797

Frequently Asked Questions

Who can join the NCT06598397 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus (HIV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06598397 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT06598397 currently recruiting?

Yes, NCT06598397 is actively recruiting participants. Contact the research team at jennifer.cantrell@nyu.edu for enrollment information.

Where is the NCT06598397 trial being conducted?

This trial is being conducted at New York, United States.

Who is sponsoring the NCT06598397 clinical trial?

NCT06598397 is sponsored by New York University. The trial plans to enroll 500 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology