Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study (NCT03930342) | Clinical Trial Compass
CompletedNot Applicable
Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
United States404 participantsStarted 2019-03-28
Plain-language 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.
Who can participate
Age range
18 Years – 44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study focused on reducing alcohol-exposed pregnancies in Native communities — given that context, would my background or community situation make this research relevant to my own care decisions around alcohol use and contraception?
2Since this trial has already been completed, would my doctor be able to share or access any published findings about whether the intervention actually reduced the risk of alcohol-exposed pregnancies, and what that might mean for my situation?
3The study looked at both alcohol use and contraceptive effectiveness together as linked issues — does my doctor think addressing both at the same time is a better approach for me than handling them separately?
4Because this trial is listed as Phase NA, which often means it's a behavioral or community-based study rather than a drug trial, what does my doctor think the evidence from this kind of research can and can't tell us about safety and effectiveness compared to standard clinical treatments?
5Are there any programs or interventions similar to what this study tested that are currently available to me, now that the trial itself is closed to enrollment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Risk of Alcohol Exposed Pregnancy
Timeframe: Baseline, 3 months and 6 months post intervention