protocolSection identificationModule nctId: NCT06324929, orgStudyIdInfo id: HSR220448, secondaryIdInfos id: R61AA030581-01, type: NIH, link: https://reporter.nih.gov/quickSearch/R61AA030581-01, briefTitle: Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1, acronym: CARRII Native, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, collaborators name: University of Minnesota, collaborators name: Missouri Breaks Industries Research, Inc., collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The purpose of this aim of the ovedrall study is to gather information to inform the development of a digital app that can be used on any platform (smartphone, tablet, computer) for Native American women to help them avoid a pregnancy affected by alcohol., conditionsModule conditions: Alcohol Exposed Pregnancy, conditions: Unplanned Pregnancies, conditions: Alcohol Use, Unspecified, conditions: Contraception Use, conditions: Sexual Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Mixed methods research during Aim 1 will include 4 different components. They are:1. Convene working group of Native American stakeholders.2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region (rural Great Northern Plains), urban Denver and mountain West, and rural Southwest .3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women across 10 focus group discussions. Content will be informed by Components 1 and 2, and will be added via modification request4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Virginia Fontaine Research Park, city: Charlottesville, state: Virginia, zip: 22908, country: United States, contacts name: Karen Ingersoll, PhD, role: CONTACT, phone: 804-651-6929, email: kes7a@uvahealth.org, geoPoint lat: 38.02931, lon: -78.47668, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-24, uploadDate: 2024-03-22T09:41, filename: Prot_SAP_000.pdf, size: 558452, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-02, uploadDate: 2024-03-22T09:41, filename: ICF_001.pdf, size: 242257, hasResults: False