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Optimizing a Digital AEP Risk Intervention With Native Women and Communities

NCT06324929 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2026-04-08

No results posted yet for this study

Summary

The purpose of Aim 1 of the study is to gather quantitative and qualitative information to inform the development of a digital app tailored for Native American women to help them avoid a pregnancy affected by alcohol. In Aim 2, we will Pilot test 5 new candidate components tailored to Native women at risk of AEP

Conditions

  • Alcohol Exposed Pregnancy
  • Unplanned Pregnancy
  • Alcohol Use, Unspecified
  • Contraception Use
  • Sexual Behavior

Interventions

BEHAVIORAL

CARRII Native Rapid Pilot Testing

The candidates that will be tested are: 1) Telephone-administered 30 day timeline follow-back of drinking, sex, and contraception, administered by phone at enrollment and monthly, which should increase awareness of AEP risk and motivation for alcohol and contraception behavior change, 2) Mailed pregnancy tests sent monthly to raise consciousness of pregnancy risk and to detect a new pregnancy early, which should increase motivation for contraception behavior change, 3) Automated, personalized digital safer sex and drink counting/reduction skills training, to improve drinking self-management skills and self-efficacy for drinking reduction and contraception use, 4) Fully automated text messages prompting usage of safer sex and drink reduction skills, which should increase self-efficacy for behavior change, and 5) access to an anonymized Community Message Board of Native women to discuss challenges in behavior change, which should increase perceived social support.

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • Missouri Breaks Industries Research, Inc.

    collaborator OTHER

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2025-10-28
Completion
2026-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06324929 on ClinicalTrials.gov