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New study aims to help HIV patients kick the habit for good

NCT ID NCT06598397

Disease control Sponsor: New York University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing a combination of counseling, peer mentoring, text messages, and nicotine replacement therapy to help people with HIV quit smoking. Researchers will enroll 500 smokers living with HIV in New York City to find the most effective and affordable approach. The goal is to improve health outcomes by reducing smoking rates in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nicotine replacement therapy (patch or lozenge)
What this could lead to
If successful, this could provide an effective, low-cost way to help people with HIV quit smoking, improving their overall health and reducing smoking-related risks.
What could go wrong
This is a Phase 4 optimization study, not a test of a new drug. The interventions are behavioral and supportive, so results may vary and quitting success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease nicotine dependence Smoking Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human immunodeficiency virus (HIV) Smoking cessation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New York University School of Global Public Health

    RECRUITING

    New York, New York, 10003, United States

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