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Digital Intervention for Alcohol-Exposed Pregnancy Prevention (CARRII Native Trial)

N/A

Recruiting

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Native American

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to collect information to create a digital app that Native American women can use on any device to prevent alcohol-affected pregnancies. Desired output format: "This trial aims to create a

Who is the study for?

This trial is for Native American women who are interested in a digital app designed to help prevent pregnancies affected by alcohol. The study seeks participants engaged in sexual activity, using birth control, or with concerns about alcohol use and pregnancy.

What is being tested?

The study is testing the effectiveness of a new digital application that works on smartphones, tablets, and computers. It aims to support Native American women in preventing unintended pregnancies influenced by alcohol consumption.

What are the potential side effects?

Since this trial involves a survey-based intervention through a digital app rather than medication or medical procedures, there are no direct physical side effects associated with participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aim 1 SurveyExperimental Treatment1 Intervention

We will enroll up to 300 Native women ages 18-44 to 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Survey

2013

N/A

~3730

0 / 1Eligibility criteria met