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

Alcohol Drinking Clinical Trial

— Native-CHOICES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03930342
• Other study ID #: 17162-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Fetal alcohol spectrum disorder (FASD) prevalence is up to 10 times higher in American Indians and Alaska Natives (AI/ANs) than in the general US population, yet FASD is 100% preventable. Even moderate alcohol use during pregnancy can affect fetal growth and behavioral outcomes. Alcohol use disorders and binge drinking in women are among the strongest risk factors for FASD in their offspring. AI/ANs have the highest prevalence of alcohol use disorders among US racial and ethnic groups, and are the most likely to engage in binge drinking during pregnancy. A growing consensus indicates that prevention of alcohol-exposed pregnancy must begin before conception. One promising approach is the Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study (CHOICES), which combines motivational interviewing with contraception counseling for non-pregnant women. In a randomized trial, women receiving CHOICES were 36% more likely to have reduced risk for alcohol-exposed pregnancies after 6 months than women receiving usual care, but the trial did not enroll AI/ANs or rural women. Although the Centers for Disease Control and Prevention has recommended its dissemination, the public health value and cost-effectiveness of CHOICES in AI/ANs is unknown. We propose a randomized controlled trial of an adapted intervention - Native-CHOICES - to reduce risk of alcohol exposed pregnancies in 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. Native-CHOICES will consist of 2 motivational interviewing sessions plus 1 contraceptive counseling session over 4 weeks, with supportive electronic messaging for 3 months to increase perceived social connectedness and support for modifying drinking behavior and using contraception.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: November 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Complicating Childbirth
• Contraceptive Usage

Intervention

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.

Locations

Country	Name	City	State
United States	Missouri Breaks Industries Research Inc	Eagle Butte	South Dakota
United States	Missouri Breaks Industries Research Inc	Rapid City	South Dakota

Sponsors (5)

Lead Sponsor	Collaborator
Washington State University	Missouri Breaks Industries Research, Inc., Sanford Research, University of Colorado, Denver, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in alcohol exposed pregnancy	Our primary outcome is reduction in risk of alcohol exposed pregnancy, defined as no heavy or binge drinking or effective contraception use, or both.	Baseline, 6 weeks, 3 months and 6 months post intervention