Clinical trial NCT06324929: Optimizing a Digital AEP Risk Intervention With Native Women and Communities
Official title: Optimizing a Digital AEP Risk Intervention With Native Women and Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Exposed Pregnancy
Unplanned Pregnancy
Alcohol Use, Unspecified
Contraception Use
Sexual Behavior
Keywords: Native American
female
adult
contraception
alcohol
digital intervention
optimization
mHealth
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Missouri Breaks Industries Research, Inc.
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-03-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed methods research during Aim 1 will include 4 different components. They are:

1. Convene working group of Native American stakeholders.
2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region (rural Great Northern Plains), urban Denver and mountain West, and other Native communities..
3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women across 10 focus group discussions. Content will be informed by Components 1 and 2, and will be added via modification request
4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women.
Primary purpose: OTHER

Brief summary: 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Native American

Exclusion Criteria:

-

Primary outcomes:
measure: Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Fontaine Research Park
state: Virginia
Study officials:
References: