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Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study

NCT03930342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2025-04-17

Study results available
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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.

Conditions

  • Contraceptive Usage
  • Alcohol Use Complicating Childbirth
  • Alcohol Drinking

Interventions

BEHAVIORAL

Native-CHOICES

Native CHOICES is a behavioral intervention for prevention of prenatal alcohol exposure in women at high risk for alcohol-exposed pregnancies. The intervention uses motivational interviewing and cognitive-behavioral strategies, and targets adoption of effective contraception and reduction of alcohol use.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Sanford Research

    collaborator OTHER

  • Missouri Breaks Industries Research, Inc.

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Washington State University

    lead OTHER

Principal Investigators

  • Michael McDonell, MD · Washington State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930342 on ClinicalTrials.gov