Contraceptive UsageNative-CHOICESNCT03930342
Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
A study testing Native-CHOICES in people with Contraceptive Usage and Alcohol Use Complicating Childbirth, run by Washington State University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Alcohol Use Complicating Childbirth, Alcohol Drinking
- What is being tested?
- Native-CHOICES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Mar 2019to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosed as infertile
- Pregnant
- Effectively using contraceptives defined by standard methods
- Living in a household with someone who is already enrolled in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Missouri Breaks Industries Research Inc
Eagle Butte, South Dakota, 57625
Missouri Breaks Industries Research Inc
Rapid City, South Dakota, 57701
About this study
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.
Read the 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.
- Being tested
- Native-CHOICES
- Medical subject headings
- Contraception Behavior, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native-CHOICESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Native CHOICES Intervention | Experimental | 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. Receives: Behavioral: Native-CHOICES |
| Wait-list Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Alcohol Exposed Pregnancy
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.
Measured: Baseline, 3 months and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start28 Mar 2019
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomized 1:1 to the intervention or usual care conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Sanford Research, Missouri Breaks Industries Research, Inc., University of Minnesota
- Responsible party
- Principal investigator, Michael McDonell, Washington State University
- Investigators
- Michael McDonell, MD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930342
- Sponsor's protocol ID
- 17162-001
- Acronym
- Native-CHOICES
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2019
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
- ClinicalTrials.gov ID
- NCT03930342
- Acronym / sponsor ID
- Native-CHOICES / 17162-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Sanford Research, Missouri Breaks Industries Research, Inc., University of Minnesota
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Women will be randomized 1:1 to the intervention or usual care conditions.
| Arm | Type | Receives |
|---|---|---|
| Native CHOICES Intervention | Experimental | Behavioral: Native-CHOICESNative-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. |
| Wait-list Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Diagnosed as infertile
- Pregnant
- Effectively using contraceptives defined by standard methods
- Living in a household with someone who is already enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Native-CHOICESNative 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. | Behavioural | Native CHOICES Intervention |
Primary outcome
Risk of Alcohol Exposed Pregnancy
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McDonell, MD principal investigator
Washington State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native-CHOICES in people with Contraceptive Usage and Alcohol Use Complicating Childbirth, run by Washington State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Alcohol Exposed Pregnancy (time frame: Baseline, 3 months and 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.