Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1 — CARRII Native  

Sexual Behavior Clinical Trial

Official title: Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1

Status Recruiting

Clinical Trial Summary

The purpose of this aim 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.

Clinical Trial 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.

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. ;

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Exposed Pregnancy
• Alcohol Use, Unspecified
• Contraception Use
• Sexual Behavior
• Unplanned Pregnancy

• NCT number: NCT06324929
• Study type: Interventional
• Source: University of Virginia
• Contact: Karen S Ingersoll, PhD
• Phone: 434-982-5960
• Email: KES7A@uvahealth.org
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Completion date: March 31, 2025