Not Yet RecruitingNot Applicable

CARRII Native Intervention Optimization Trial

United States512 participantsStarted 2026-06-01

Plain-language summary

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 intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.

Who can participate

Age range18 Years – 44 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Rate of Alcohol Exposed Pregnancy (AEP) Risk

Timeframe: 3 months

Trial details

NCT IDNCT07547696

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Karen S Ingersoll, PhD

434-982-5960 KES7A@uvahealth.org

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials