CARRII Native Intervention Optimization Trial

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07547696
Status
Not Yet Recruiting

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Conditions

  • Alcohol Exposed Pregnancy
  • Alcohol-Related Disorders
  • Contraception Behavior
  • Drinking, Alcohol
  • Fetal Alcohol Spectrum Disorders
  • Pregnancy
  • Sexual Behavior

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • CARRII Native Cores — OTHER
    4 Cores plus combination of 0, 1, 2, or 3 additional components

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
512 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: 1. New intervention components: All Off
    CARRII Cores New intervention components: All Off
  • Other: 2. New intervention components: C
    CARRII Cores New intervention components: C
  • Other: 3. New intervention components: B
    CARRII Cores New intervention components: B
  • Other: 4. New intervention components: B and C
    CARRII Cores New intervention components: B and C
  • Other: 5. New intervention components: A
    CARRII Cores New intervention components: A
  • Other: 6. New intervention components: A and C
    CARRII Cores New intervention components: A and C
  • Other: 7. New intervention components: A and B
    CARRII Cores New intervention components: A and B
  • Other: 8. New intervention components: A, B, and C
    CARRII Cores New intervention components: A, B, and C

Primary Outcome Measure

Rate of Alcohol Exposed Pregnancy (AEP) Risk [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Fontaine Research ParkCharlottesvilleVirginia22908-

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By research site
University of Virginia Fontaine Research Park· Charlottesville, VA

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