Optimizing a Digital AEP Risk Intervention with Native Women and Communities

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Over 3.3 million US women per month are at risk for Alcohol-Exposed Pregnancy (AEP). Prenatal alcohol exposure can cause lifetime costly intellectual and physical disabilities in children. Risk for AEP is greater among Native Americans, because rates of unintended pregnancy and binge/heavy drinking are inequitable between Native women and the general population. AEP counseling interventions for Native women are efficacious, but too costly to sustain. Digital interventions increase the reach of evidence-based behavioral interventions while reducing cost. This project will tailor and optimize the first digital AEP intervention, CARRII, piloted in a general population of women with AEP risk, for Native women. Guided by the Multiphase Optimization Strategy (MOST), we will systematically test a Native-tailored version of CARRII with candidate novel components to develop an optimized intervention for Native women at risk of AEP. 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. In R61 Aim 1, we will identify needs for a digital intervention for AEP risk reduction for Native women, determine the best strategies for their engagement, evaluate and tailor CARRII intervention components for Native women, and deploy CARRII and new intervention components on a platform that is accessible on any device. In R61 Aim 2, we will tailor 5 new candidate intervention components that vary in automation and hypothesized impact on AEP risk behavior, and determine their costs and short-term effect sizes on alcohol and contraception. The 5 candidates are: repeated timeline follow-back AEP risk interviews, monthly pregnancy testing, digital training on skills for safer sex and reduced drinking, automated text messaging to prompt use of safer sex and reduced drinking skills, and access to an anonymized participant community message board. We will test each component in 6-week pre-post trials with 50 Native women to assess independent effects on drinking and contraception while considering practical aspects such as frequency and duration of contact with participants and costs of each component. Achieving R61 milestones will permit progression to the R33 phase. In R33 Aim 3, we 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. We 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 RCT. This project will be the first to systematically optimize a digital AEP intervention tailored for Native women at acceptable costs. The project will prepare the team for the first nationwide RCT of an optimized, sustainable digital AEP intervention tailored with and for Native women at risk of AEP to reduce AEPs in this high risk subpopulation.