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New online tool aims to cut Alcohol-Related birth risks in native communities

NCT ID NCT07547696

Prevention Sponsor: University of Virginia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests different combinations of an online program called CARRII, designed to help Native American women reduce their risk of alcohol-exposed pregnancy. Over 500 participants will be randomly assigned to one of eight versions of the program for three months. The goal is to find the most effective and affordable mix of components to support healthy pregnancies.

What this could mean

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

Active substance
online behavioral intervention (CARRII Native Cores)
What this could lead to
If successful, this could provide an effective, low-cost online tool to help Native women prevent alcohol-exposed pregnancies.
What could go wrong
This is an early optimization trial, not a final test. The intervention may not reduce risk as hoped, and results may not apply to all communities.

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 512 people

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

Started

Jun 2026

Expected to finish

Jul 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 to 44 years

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: * Native American/American Indian/Alaska Native, * who are not surgically sterile, * who report alcohol consumption at risk levels and risk for pregnancy in the past 90 days due to having sex with a man with inconsistent, ineffective, or no contraception. * Participants must have access to the Internet via a mobile device they can access daily Exclusion Criteria: * cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking alcohol-related disorders Contraception Behavior fetal alcohol spectrum disorder fetal alcohol syndrome Risk Reduction Behavior Sexual Behavior

As listed by the trial registrant

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

Alcohol exposed pregnancy Alcohol-related disorders Contraception behavior Drinking, alcohol Fetal alcohol spectrum disorders Pregnancy Sexual behavior

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

  • University of Virginia Fontaine Research Park

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

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