Clinical trial Recruiting at 1 site Interventional Ages 18 to 44 Women only

CARRII Native Intervention Optimization: Finding the Best Online Help for Native Women at Risk of Alcohol-Exposed Pregnancy

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

Run by University of Virginia · NCT07547696 · Data updated 2026-11-12

This trial tests different online components of CARRII to see which mix best reduces risk of alcohol-exposed pregnancy among Native women who could become pregnant and drink.

Quick facts

Study typeInterventional
Ages18 Years to 44 Years
SexWomen only
Enrollment512 (estimated)
SponsorUniversity of Virginia
Academic / other
Locations1 site (Charlottesville, Virginia)
StatusRecruiting
StartedJune 2, 2026
Main results expectedJune 30, 2028
Study endsJuly 30, 2028
Registry record updatedJune 23, 2026
Trial IDNCT07547696 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Native American/Alaska Native women who have had sex with a partner using inconsistent or no contraception and who report at-risk alcohol use in the past 90 days, with daily mobile internet access.

Probably not a fit

Participants without ongoing risk of alcohol-exposed pregnancy or without sustained engagement with the online platform may see no direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a large factorial design over 3 months to compare multiple components of the CARRII Native online intervention. It aims to identify the most effective and cost-efficient version for reducing AEP risk while engaging Native communities. The protocol includes exploratory analyses of how and for whom the components work and feasibility metrics for a future randomized trial. The trial focuses on Native American/Alaska Native women who drink at risk levels and have potential pregnancy risk due to inconsistent contraception, with internet access via mobile devices. Lead sites include the University of Virginia with collaboration from the University of Minnesota.

Why it matters

Potential benefit: If successful, the optimized online intervention could more effectively reduce the risk of alcohol-exposed pregnancies among Native women while staying affordable for Native communities.

How similar studies have gone: Prior online interventions for AEP risk have shown promise in some populations; this study tests a novel, factorial optimization approach within a Native-focused context.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Virginia Fontaine Research Park
    Charlottesville, Virginia, United States
    Recruiting

Study contacts

  • Principal investigator: Karen S Ingersoll, PhD — University of Virginia
  • Study coordinator: Silvia P Park, BA
  • Email: spp2d@uvahealth.org
  • Phone: 855-488-2227

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.