Clinical trial NCT03930342: Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Official title: Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Alcohol Use Complicating Childbirth
Alcohol Drinking
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Sanford Research
name: Missouri Breaks Industries Research, Inc.
name: University of Minnesota
First posted: 2019-04-29
Enrollment: 404
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women will be randomized 1:1 to the intervention or usual care conditions.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Risk of Alcohol Exposed Pregnancy
timeFrame: Baseline, 3 months and 6 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Eagle Butte
country: United States
facility: Missouri Breaks Industries Research Inc
state: South Dakota
city: Rapid City
country: United States
facility: Missouri Breaks Industries Research Inc
state: South Dakota
Study officials:
affiliation: Washington State University
name: Michael McDonell, MD
role: PRINCIPAL_INVESTIGATOR
References: