CARRII Native Intervention Optimization Trial

April 16, 2026 updated by: Karen Ingersoll, University of Virginia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Fontaine Research Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1. New intervention components: All Off
CARRII Cores New intervention components: All Off
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 2. New intervention components: C
CARRII Cores New intervention components: C
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 3. New intervention components: B
CARRII Cores New intervention components: B
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 4. New intervention components: B and C
CARRII Cores New intervention components: B and C
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 5. New intervention components: A
CARRII Cores New intervention components: A
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 6. New intervention components: A and C
CARRII Cores New intervention components: A and C
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 7. New intervention components: A and B
CARRII Cores New intervention components: A and B
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components
Other: 8. New intervention components: A, B, and C
CARRII Cores New intervention components: A, B, and C
Other: CARRII Native Cores
4 Cores plus combination of 0, 1, 2, or 3 additional components

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

University of Minnesota

Investigators

  • Principal Investigator: Karen S Ingersoll, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBS7390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This project will generate electronic, de-identified data that will be placed in a readily accessible public database of NIAAA data, which is managed in the NIMH Data Archive.

Investigators will comply with all data sharing procedures specified by NIAAA and follow procedures described in the National Institute of Mental Health (NIMH) Data Archive (NDa) Sharing summary of tasks and expectations.

IPD Sharing Time Frame

12 months after data analysis is completed, investigators will deposit it in the data archive

IPD Sharing Access Criteria

Other researchers can request data from the NIAAA Data Archive using their procedures.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol-Related Disorders

Clinical Trials on CARRII Native Cores

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe