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Smartphone program aims to help HIV patients kick the habit

NCT ID NCT05014282

Disease control Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a smartphone-based program can help people living with HIV quit smoking better than standard phone counseling. About 638 participants will use nicotine patches and lozenges along with either automated video coaching or traditional quitline support. The goal is to see which approach leads to more people staying smoke-free long-term.

What this could mean

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

Active substance
Nicotine patch and nicotine lozenge
What this could lead to
If successful, this could provide an effective, low-cost way to help people with HIV quit smoking, reducing their risk of smoking-related diseases.
What could go wrong
This is a behavioral intervention trial, not a new drug. Success depends on participants' adherence, and results may not apply to all smokers with HIV.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

638 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Sep 2026

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: * smoked \>/=100 cigarettes in lifetime * English or Spanish speaking * Currently smoke \> 5 cigarettes/day * Willing to make a quit attempt within 1 week of enrollment * HIV positive * Process a smartphone compatible with the project app * Have a valid email address Exclusion Criteria: * Currently pregnant or breastfeeding * Current use of smoking cessation medications * Enrolled in a smoking cessation study * Household member enrolled in the study * Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone

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Conditions

The condition(s) this trial relates to.

Smoking Cessation

As listed by the trial registrant

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

Smoking cessation

Contacts and locations

Locations

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.