Back to Trials
NCT07547696NARecruitingAccepts Healthy Volunteers

CARRII Native Intervention Optimization Trial

University of Virginia

Start Date

6/2/2026

Completion Date

7/30/2028

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.

Detailed Description

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).

Eligibility Criteria

Age Range: 18 years to 44 years

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.

Interventions

OTHER

CARRII Native Cores

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Fetal Alcohol Spectrum DisordersPregnancyAlcohol-Related DisordersDrinking, AlcoholContraception BehaviorAlcohol Exposed PregnancySexual Behavior

Locations

University of Virginia Fontaine Research Park

Charlottesville, Virginia 22908

United States