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Can a phone app help women at risk of HIV start PrEP?

NCT ID NCT06853314

Prevention Sponsor: Columbia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a mobile health program called WINGS+PrEP for women who have experienced heavy drinking, partner violence, and involvement with the criminal legal system. The program provides information about PrEP (a daily pill that prevents HIV) and offers support sessions. Researchers want to see if this approach helps more women start and stay on PrEP compared to standard care. The trial will enroll 307 HIV-negative women and follow them for 6 months.

What this could mean

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

Active substance
behavioral intervention (mobile health program with PrEP decision aid and peer navigation)
What this could lead to
If it works, this could provide an effective way to increase PrEP use and reduce HIV risk among women facing heavy alcohol use and partner violence.
What could go wrong
This is a behavioral intervention, not a drug, so results depend on participant engagement. The trial is relatively small (307 people) and may not apply to all women.

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 307 people

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

Started

Apr 2026

Expected to finish

Jun 2027

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

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Identify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services. Meet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure Exclusion Criteria: Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions. Inability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)

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Conditions

The condition(s) this trial relates to.

alcohol abuse HIV infectious disease prevention target

As listed by the trial registrant

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

Alcohol use disorder HIV infections Violence, gender-based

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

  • The Columbia Community Partnership for Health

    RECRUITING

    New York, New York, 10033, United States

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