Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03930342
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
University of Colorado, Denver
Sanford Research
Missouri Breaks Industries Research, Inc.
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Dedra Buchwald, Washington State University

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 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.

Condition or disease Intervention/treatment Phase
Contraceptive Usage Alcohol Use Complicating Childbirth Alcohol Drinking Behavioral: Native-CHOICES Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Women will be randomized 1:1 to the intervention or usual care conditions.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : March 14, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Native CHOICES Intervention
Native-CHOICES will comprise usual care plus 2 MI sessions delivered over 4 weeks; a contraception counseling session at a local clinic; and 3 months of electronic messaging to boost the effects of MI and counseling by increasing perceptions of social connection and social support for behavior change. Contraception counseling will be completed within 2 weeks after the second MI session, so the maximum duration of MI and counseling for each participant will be 6 weeks. Electronic messaging will include positive motivational content consistent with alcohol and contraception use goals set in the MI sessions.
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.

No Intervention: Wait-list Control Group
The control condition will comprise usual care for the 6-month study period, with a wait-list design that offers women the Native- CHOICES program after they have completed the 6-month data collection.



Primary Outcome Measures :
  1. Reduction in alcohol exposed pregnancy [ Time Frame: Baseline, 6 weeks, 3 months and 6 months post intervention ]
    Our primary outcome is reduction in risk of alcohol exposed pregnancy, defined as no heavy or binge drinking or effective contraception use, or both.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930342


Contacts
Layout table for location contacts
Contact: Dedra Buchwald, MD 206-708-8622 dedra.buchwald@wsu.edu
Contact: Odile Madesclaire, MPH 206-708-8617 odile.madesclaire@wsu.edu

Locations
Layout table for location information
United States, South Dakota
Missouri Breaks Industries Research Inc Recruiting
Eagle Butte, South Dakota, United States, 57625
Contact: Marcia O'Leary, BSN         
Sponsors and Collaborators
Washington State University
University of Colorado, Denver
Sanford Research
Missouri Breaks Industries Research, Inc.
University of Minnesota - Clinical and Translational Science Institute
Investigators
Layout table for investigator information
Principal Investigator: Dedra Buchwald, MD Washington State University

Layout table for additonal information
Responsible Party: Dedra Buchwald, Principal Investigator, Washington State University
ClinicalTrials.gov Identifier: NCT03930342     History of Changes
Other Study ID Numbers: 17162-001
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs