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CARRII Native Intervention Optimization Trial

CARRII Native Intervention Optimization Trial

Recruiting
18-44 years
Female
Phase N/A

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Overview

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.

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

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.

Study details
    Fetal Alcohol Spectrum Disorders
    Pregnancy
    Alcohol-Related Disorders
    Drinking
    Alcohol
    Contraception Behavior
    Alcohol Exposed Pregnancy
    Sexual Behavior

NCT07547696

University of Virginia

27 June 2026

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