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临床试验/NCT03930342
NCT03930342已完成不适用

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

Washington State University3 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2019年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
404
试验地点
3
主要终点
Risk of Alcohol Exposed Pregnancy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosed as infertile
  • Effectively using contraceptives defined by standard methods
  • Living in a household with someone who is already enrolled in the study

结局指标

主要结局

Risk of Alcohol Exposed Pregnancy

时间窗: Baseline, 3 months and 6 months post intervention

Our primary outcome is measurement of change in risk of alcohol exposed pregnancy (AEP). Being at risk for an AEP is defined as engaging in heavy/binge drinking and ineffective contraception use in the 3 months prior to the final data collection session after exposure to the intervention. Count reflects number of participants who remained at risk for an AEP.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael McDonell

Principal Investigator

Washington State University

研究点 (3)

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