N/A
Completed N=404
Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Contraceptive Usage · Alcohol Use Complicating Childbirth · Alcohol Drinking
Source: ClinicalTrials.gov NCT03930342 ↗
Enrolled (actual)
404
Serious AEs
0.3%
Results posted
Apr 2025
Primary outcomePrimary: Risk of Alcohol Exposed Pregnancy — 103; 99 Participants
Summary
Native CHOICES is a randomized controlled trial of an adapted intervention to reduce the risk of alcohol exposed pregnancies in American Indians and Alaska Natives (AI/ANs). We will enroll 350 AI/AN women living on the Cheyenne River Sioux Indian Reservation or in Rapid City in South Dakota who are 18-44 years old, have risky drinking behaviors, are not currently pregnant but are able to become pregnant, and are sexually active but not using effective contraception.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk of Alcohol Exposed Pregnancy |
103; 99 | — |
Eligibility Criteria
Inclusion Criteria
- Native American Woman
- 18-44 years old at the time of recruitment
- Self-report high-risk drinking behavior (average 8 or more drinks per week) or episodes of binge drinking (four or more drinks on a single occasion) in the past 90 days
- Have vaginal sex with a male partner in the past 30 days
Exclusion Criteria
- Diagnosed as infertile
- Pregnant
- Effectively using contraceptives defined by standard methods
- Living in a household with someone who is already enrolled in the study
Data sourced from ClinicalTrials.gov (NCT03930342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.