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NCT Number: NCT07547696

CARRII Native Intervention Optimization Trial

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.

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Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol Drinking Alcohol Exposed Pregnancy Alcohol-Induced Disorders Alcohol-Related Disorders Behavior Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Contraception Behavior Drinking Behavior Drinking, Alcohol Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Mental Disorders Pregnancy Pregnancy Complications Reproductive Behavior Risk Reduction Behavior Sexual Behavior Substance-Related Disorders Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Fontaine Research Park

Charlottesville, Virginia, 22908, United States

Location status: Recruiting

Location contact

Karen Ingersoll, PhD

CONTACT

[email protected]

8046516929

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CARRII Native Cores

Other

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

Primary outcomes

  1. Rate of Alcohol Exposed Pregnancy (AEP) Risk

    Time frame: 3 months

    The primary outcome will be risk of alcohol-exposed pregnancy in the past month, at the 3 Month (3M) follow-up via daily diary reporting of alcohol consumption, intercourse and contraception use.

    AEP risk is defined as 1) had vaginal sex with a male during the past 4 weeks, 2) drank alcohol at risk levels during the past 30 days (For women, risky alcohol use is drinking more than 7 standard drinks per week, or more than 3 standard drinks per occasion, or both), 3) past month intermittent or no contraception, and 4) not being sterile and not having a partner (or partners) known to be sterile.

Secondary outcomes

  1. Rate of risky alcohol use

    Time frame: 3 months

    This outcome will measure the rate of risky alcohol use in the past month, at 3 months follow-up via daily diary reporting. For women, risky alcohol use is drinking more than 7 standard drinks per week, or more than 3 standard drinks per occasion, or both.

  2. Rate of risky contraception

    Time frame: 3 months

    This outcome will measure the rate of risky contraception use in the past month, at 3 months follow-up via daily diary reporting. Risky contraception occurs when a fertile woman has sexual intercourse with a man without contraception, or using only ineffective methods, or using an effective method incorrectly or intermittently

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia P Park, BA

CONTACT

[email protected]

855-488-2227

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • University of Minnesota

Registry information

Official study title

CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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