Optimizing a Digital AEP Risk Intervention With Native Women and Communities (CARRIINative)

The purpose of Aim 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol. In Aim 2, we will Pilot test 5 new candidate components tailored to Native women at risk of AEP

Study Overview

• Status: Active, not recruiting
• Conditions: Sexual Behavior; Alcohol Use, Unspecified; Alcohol Exposed Pregnancy; Unplanned Pregnancy; Contraception Use
• Intervention / Treatment: Behavioral: CARRII Native Rapid Pilot Testing

Detailed Description

Alcohol exposed pregnancy (AEP) can result in Fetal Alcohol Spectrum Disorders (FASDs) that cause lifelong costly disabilities from brain, organ, tissue, and neurological damage. While over 3.3 million US women per month are at risk for AEP, risk for AEP among Native American (Native) women is higher, due to low contraception use and high binge drinking rates. For example, 20% of sexually active Native women in the Southwestern US are at risk for AEP, and 52% of pregnancies in the Navajo Nation are unplanned, compared to 45% nationally. Among pregnant women from Great Plains tribes, nearly 30% drink at binge levels and do not use contraception to prevent pregnancy. Among another sample of Native women from Great Plains tribes, 65% were sexually active, not seeking pregnancy, and not using contraception.

For Aim 1 we will implement four study methods to evaluate and tailor CARRII digital intervention components for Native women and prepare them to be used in a subsequent trial. These iterative mixed methods formative studies include:

1. Develop an ongoing Native Partners Working Group to review study plans and findings over time with the research team,
2. Collect quantitative surveys from Native women to estimate rates of AEP risk, interest/ ability to participate, health literacy, and other factors (n=300),
3. Conduct Focus Groups to prototype and tailor new CARRII components (up to n=60), and
4. Conduct Think-aloud User Testing (n=20) to finalize a draft of the CARRII Native intervention to prepare for development on a responsive design platform.

After incorporating input from participants (SA 1) and the Native Partners Working Group, we will pilot candidate components (SA2) to assess independent effects on AEP behavioral risk factors (drinking and contraception) while considering practical aspects such as frequency and duration of contact with participants, and costs of each component.

AEP can be prevented by avoiding an unintended pregnancy or reducing alcohol intake by those who may become pregnant. PI Ingersoll was a PI on the seminal CHOICES study that developed the first efficacious theory-based AEP intervention, with 4 Motivational Interviewing (MI) counseling sessions. PI Hanson adapted CHOICES for Native women in tribal communities. The Native-adapted CHOICES reduced AEP risk among Native women, but was too costly to sustain for high-risk women and communities.

In contrast, theory-based digital interventions are highly accessible, more convenient, scalable, and more sustainable, while still efficacious. In R34AA020853, Ingersoll piloted the first automated digital AEP intervention, CARRII. A nationwide pilot randomized controlled trial (RCT) showed that CARRII (but not the education control) significantly reduced AEP risk and pregnancy risk at 3 and 6 months, and drinking risk at 3 months. However, CARRII was studied among general population women, and not Native American women specifically.

Because rates of unintended pregnancy and binge drinking that create AEP risk are inequitable between Native women and the general population, CARRII will be tailored to and optimized for this priority subgroup. Guided by the Multiphase Optimization Strategy (MOST), we will tailor CARRII's existing components for Native women and systematically test proposed novel components (derived from formative work with Native women), to develop an efficient and scalable intervention tailored to Native women at risk of AEP. Optimizing CARRII for Native women will require measuring the efficacy and costs of components to find a balance between impact and affordability for Native communities. The overarching goal of this R61/R33 proposal is to determine the optimal combination of novel intervention strategies to include with CARRII (tailored for Native women) that maximizes digital intervention efficacy at feasible cost for Native communities. Achieving R61 milestones will permit progression to the R33 phase.

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for survey:

• Native American

Inclusion Criteria for rapid pilot testing:

• Native American
• Risk for Alcohol Exposed Pregnancy

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Aim 1 Survey; We will enroll up to 300 Native women ages 18-44 to complete a 35-minute survey to characterize demographics, parity, literacy, AEP risk, drinking levels, knowledge of FASD, location, Tribal affiliation, cultural preferences for tailoring, preferred digital platforms, methods of access to mobile devices/Internet, and interest in a digital women's health study about alcohol and birth control
Experimental: Rapid Pilot Testing; Participants will complete a baseline past month TLFB (timeline follow-back) of alcohol use and contraception use during sex and a short online survey evaluating knowledge about AEP risk, intentions to change, self-efficacy for change, and readiness to change alcohol use and contraception behaviors. Each cohort of 10 participants will receive one of the 5 novel components (telephone-administered TLFB 2 weeks after study enrollment, mailed pregnancy test arriving 10-14 days after enrollment, digital safer sex and drink reduction skills training accessible across the 6-week period, automated texting prompting usage of skills across the 6-week period, or anonymized community message board across the 6-week period). Participants will complete a second TLFB for the past 6 weeks, and a short survey to rate the component they experienced, a System Usability Scale on their component, and measures of short-term knowledge, intentions to change, self-efficacy for change, and readiness to change.	Behavioral: CARRII Native Rapid Pilot Testing; The candidates that will be tested are: 1) Telephone-administered 30 day timeline follow-back of drinking, sex, and contraception, administered by phone at enrollment and monthly, which should increase awareness of AEP risk and motivation for alcohol and contraception behavior change, 2) Mailed pregnancy tests sent monthly to raise consciousness of pregnancy risk and to detect a new pregnancy early, which should increase motivation for contraception behavior change, 3) Automated, personalized digital safer sex and drink counting/reduction skills training, to improve drinking self-management skills and self-efficacy for drinking reduction and contraception use, 4) Fully automated text messages prompting usage of safer sex and drink reduction skills, which should increase self-efficacy for behavior change, and 5) access to an anonymized Community Message Board of Native women to discuss challenges in behavior change, which should increase perceived social support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of risky drinking	Defined as binge drinking, and/or drinking over daily risk levels. Unit of measure: Rate of risky drinking Measurement tool: TLFB (timeline follow-back) of alcohol use and contraception use during sex Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.	6 weeks
Rate of ineffective/absent contraception use	Defined per method used, or none, when having sex. Unit of measure: Rate of ineffective/absent contraception use Measurement tool: TLFB (timeline follow-back) of alcohol use and contraception use during sex Outcomes 1 and 2 are combined to define alcohol-exposed pregnancy risk.	6 weeks
Rate of AEP Risk	Combination of drinking above risk levels and inconsistent or absent use of effective contraception	6 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Minnesota; Missouri Breaks Industries Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Actual): October 28, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: adult; alcohol; contraception; digital intervention; female; optimization; Native American; mHealth (mobile health)
• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking; Sexual Behavior
• Other Study ID Numbers: SBS6760; R61AA030581-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will comply with NIH data sharing protocols and will upload data to the NIAAA Data archive.
• IPD Sharing Time Frame: 12 months after data analysis is completed, we 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