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

Sexual Behavior Clinical Trial

— CARRII Native  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324929
• Other study ID #: HSR220448
• Secondary ID: R61AA030581-01
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: University of Virginia
• Contact: Karen S Ingersoll, PhD
• Phone: 434-982-5960
• Email: KES7A[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Native American

Exclusion Criteria:

-

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Survey
Participants 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.

Locations

Country	Name	City	State
United States	University of Virginia Fontaine Research Park	Charlottesville	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
University of Virginia	Missouri Breaks Industries Research, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention.	We will use mixed methods formative work including Focus Groups and brief surveys to determine the best strategies for recruitment and the potential reach of the intervention by determining the number, proportion, and representativeness of Native women willing to participate. Mixed methods formative work will also identify population characteristics and needs of Native women at risk for AEP, and gather their preferences and opinions about intervention components, delivery modes, and needed modifications to improve the relevance and appeal of CARRII.; Survey Analysis: We will use descriptive statistics to determine the rate of women who are eligible for CARRII, interested in CARRII, and their demographic and digital access characteristics.	12 months