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NCT03930342: Native-CHOICES

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

Completed NA Results posted Last updated 17 April 2025
What this trial tests

NA trial testing Native-CHOICES in Contraceptive Usage in 404 participants. Completed in 30 October 2023.

Timeline
28 March 2019
Primary endpoint
30 October 2023
30 October 2023

Quick facts

Lead sponsorWashington State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment404
Start date28 March 2019
Primary completion30 October 2023
Estimated completion30 October 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington State University

Who can join

Adults 18 to 44, female only, with Contraceptive Usage or Alcohol Use Complicating Childbirth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Risk of Alcohol Exposed Pregnancy Primary · 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.

GroupValue95% CI
Native CHOICES Intervention103
Wait-list Control Group99

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected through each participant's 6-month participation in the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Native CHOICES Intervention
Serious: 1/207 (0%)
Deaths: 6/207
Wait-list Control Group
Serious: 0/201 (0%)
Deaths: 2/201

Serious adverse events (1 terms)

ReactionSystemNative CHOICES InterventionWait-list Control Group
Heart AttackCardiac disorders

Most-reported serious reactions: Heart Attack.

Data from ClinicalTrials.gov NCT03930342 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomized controlled trial of Native CHOICES: Impact on alcohol-exposed pregnancy risk reduction among American Indian and Alaska Native women.
    Hanson J, Noonan C, Oziel K, Wounded KL, et al · · 2025 · cited 4× · PMID 39710495 · DOI 10.1111/acer.15521

Verify or expand the search:

Other recruiting trials for Contraceptive Usage

Currently open trials in the same condition.

Other Washington State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03930342.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing