Recruiting

CARRII

Sponsor:

University of Virginia

Code:

NCT07547696

Conditions

Fetal Alcohol Spectrum Disorders

Pregnancy

Alcohol-Related Disorders

Drinking, Alcohol

Contraception Behavior

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

CARRII Native Cores

Study Details

Brief 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.

Conditions

Fetal Alcohol Spectrum Disorders

Pregnancy

Alcohol-Related Disorders

Drinking, Alcohol

Contraception Behavior

Study ID

NCT07547696

Start date

Jun 2, 2026

Status verified date

Jun, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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 Design

Enrollment

512 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

CARRII Native Cores

4 Cores plus combination of 0, 1, 2, or 3 additional components

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Silvia P Park, BA

855-488-2227spp2d@uvahealth.org

Locations

University of Virginia Fontaine Research Park

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Karen Ingersoll, PhD

8046516929kes7a@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Native American
  • female
  • adult
  • contraception
  • alcohol
  • digital intervention
  • mobile health (mHealth)
  • optimization
  • risk reduction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-06-23.