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Can a phone app help people with HIV kick the smoking habit?

NCT ID NCT06883097

Disease control Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two smartphone apps designed to help people living with HIV quit smoking. Participants will use one of the apps for about six months and also receive nicotine patches and gum. The goal is to see which app works better at helping people stay smoke-free, using breath and saliva tests to confirm results.

What this could mean

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

Active substance
smartphone app (Learn to Quit-HIV or QuitStart) plus nicotine replacement therapy (patches and gum)
What this could lead to
If successful, this could provide an effective, accessible tool to help people living with HIV quit smoking, reducing their risk of cancer and other diseases.
What could go wrong
This is a mid-stage trial with 314 participants, so results may not apply to everyone. The apps may not be more effective than standard support, and quitting smoking is difficult even with help.

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

About 314 people

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

Started

Aug 2025

Expected to finish

Dec 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: 1. Self-reported daily cigarette smoking over the past 30 days 2. Self-reported HIV status 3. Age 18 or older 4. Desire to quit smoking 5. Willing and medically eligible to use NRT 6. Currently receiving HIV care 7. Currently owning an Android or iOS smartphone Exclusion Criteria: 1. Current acute psychotic episode or unsafe to participate in the study 2. Pregnant or intending to become pregnant in the next 6 months 3. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation 4. Any medical condition or medication that could compromise subject safety, as determined by the PIs and/or study physician 5. Not able to fluently speak and write in English 6. Hearing, comprehension, visual, speech, or motor limitations that preclude study participation

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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.

Cancer prevention Human immunodeficiency virus (HIV) Smoking cessation Smoking cessation; tobacco dependence Tobacco Tobacco abstinence Tobacco dependence caused by cigarettes

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

  • Wake Forest University, Implementation Science

    RECRUITING

    Winston-Salem, North Carolina, 27101, United States

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