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CARRII Native Intervention Optimization Trial | Clinical Trials | Clareo Health

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Not Yet RecruitingNANCT07547696

CARRII Native Intervention Optimization Trial

The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This int...

Lead sponsor: University of Virginia•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Karen S Ingersoll, PhD

CONTACT

434-982-5960 KES7A@uvahealth.org

Silvia P Park, BA

CONTACT

434-924-3991 spp2d@uvahealth.org

Sponsors

Lead Sponsor

University of Virginia

Collaborators

University of Minnesota

In this protocol, for Aim 3, investigators will conduct a large 3-month factorial experiment with 512 participants. This design will identify the optimal intervention that efficiently balances AEP risk reduction with community-informed sustainable cost. Investigators will conduct exploratory analyses of mediation/moderation and identify study feasibility metrics (rates of Native women with AEP risk, and completing study recruitment, baseline, intervention, and follow-up vs. dropout) for a subsequent randomized control trial (RCT).

Age

18 - 44 years

Sex

FEMALE

Healthy Volunteers

Yes

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 23, 2026Terms

Trial snapshot

StatusNOT_YET_RECRUITING

PhaseNA

Enrollment512

Start dateJun 2026

Last updatedApr 23, 2026

Condition

Fetal Alcohol Spectrum Disorders Pregnancy Alcohol-Related Disorders Drinking, Alcohol Contraception Behavior+2 more

Locations shown

University of Virginia Fontaine Research Park

Charlottesville, Virginia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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