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

Alcohol Drinking Clinical Trial

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

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03930342
Study type Interventional
Source Washington State University
Contact
Status Active, not recruiting
Phase N/A
Start date March 28, 2019
Completion date November 30, 2024
View Details
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