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 Not yet recruiting

Clinical Trial Summary

The purpose of this aim of the ovedrall study is to gather information to inform the development of a digital app that can be used on any platform (smartphone, tablet, computer) 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 Native pregnant women from Great Plains tribes, nearly 30% drink at binge levels and do not use birth control to prevent pregnancy. Among another sample of Native women from Great Plains tribes, 65% were sexually active, not seeking pregnancy, and not using birth control. For Aim 1 there are four study methods that will help the team evaluate and tailor CARRII intervention components for Native women and prepare for a trial. These iterative mixed methods formative studies include: a) develop an ongoing Native Partners Working Group to review study plans and findings over time with the research team, b) Quantitative surveys to estimate rate of AEP risk, interest/ ability to participate, health literacy, and other factors (n=300), c) Focus Groups to prototype and tailor new CARRII components (up to n=60), and d) Think-aloud User Testing (n=20) to finalize the 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. Because rates of unintended pregnancy and binge drinking that create AEP risk are inequitable between Native women and the general population, CARRII must 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 Pregnancies

• NCT number: NCT06324929
• Study type: Interventional
• Source: University of Virginia
• Contact: Karen S Ingersoll, PhD
• Phone: 434-982-5960
• Email: KES7A@uvahealth.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Completion date: March 31, 2025