Digital app development to help Native women avoid alcohol-exposed pregnancies
Optimizing a Digital AEP Risk Intervention With Native Women and Communities
This study is testing a new app designed to help Native American women avoid drinking alcohol during pregnancy to prevent serious health issues for their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06324929 on ClinicalTrials.gov |
What this trial studies
This study aims to gather both quantitative and qualitative data to inform the creation of a digital application specifically designed for Native American women. The focus is on preventing alcohol-exposed pregnancies, which can lead to serious lifelong disabilities. The study will utilize a mixed-methods approach, including surveys, focus groups, and user testing, to tailor the app's components to the needs and preferences of Native women. By engaging with a Native Partners Working Group, the research team will ensure that the intervention is culturally relevant and effective.
Who should consider this trial
Good fit: Ideal candidates for this study are Native American women who are sexually active and at risk for alcohol-exposed pregnancies.
Not a fit: Patients who are not Native American or those who are not at risk for alcohol-exposed pregnancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of alcohol-exposed pregnancies among Native American women.
How similar studies have performed: While there have been studies addressing alcohol use and pregnancy prevention, this specific approach tailored for Native American women is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Native American Exclusion Criteria: -
Where this trial is running
Charlottesville, Virginia
- University of Virginia Fontaine Research Park — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Karen S Ingersoll, PhD
- Email: KES7A@uvahealth.org
- Phone: 434-982-5960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.