- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00153478
Project CHOICES Efficacy Study
Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Ft. Lauderdale, Florida, United States, 33314
- Broward County Health District Primary Care Centers
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Ft. Lauderdale, Florida, United States, 33314
- Media Recruited Participants from Broward County
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Texas
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Dayton, Texas, United States, 77030
- Plane State Jail
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Houston, Texas, United States, 77030
- Career and Recovery
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Houston, Texas, United States, 77030
- Door to Recovery
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Houston, Texas, United States, 77030
- Harris County Jail
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Houston, Texas, United States, 77030
- Houston Recovery Campus
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Houston, Texas, United States, 77030
- New Directions
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Houston, Texas, United States, 77030
- Sally's House
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Virginia
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Richmond, Virginia, United States, 23298
- Medicaid Helath Maintenance Organization
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Richmond, Virginia, United States, 23298
- Outpatient Gynecology Clinic-Virginia Commonwealth Univ
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Women who: are not pregnant, are between the ages of 18 and 44 years, consume more than seven drinks per week and/or at least one binge episode (five or more drinks in one day) in the last 90 days (for the Texas jail & recovery center sites, this will be the 90 days before entering these facilities), are able to provide and do provide informed consent, are members of the special setting's population, and are available for follow-up through 9 months after recruitment.
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Exclusion Criteria: Women who: do not meet the inclusion criteria, cannot commit to provide information about how to be contacted for follow-up, or are unable to understand spoken English.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
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Secondary Outcome Measures
Outcome Measure |
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Mediators and moderators of reduced risk in the IPC and IO groups.
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Collaborators and Investigators
Investigators
- Principal Investigator: Rosa L Floyd, DSN, Centers for Disease Control and Prevention
- Principal Investigator: Mark B Sobell, PhD, Nova Southeastern University
- Principal Investigator: Mary V. Velasquez, PhD, The University of Texas Health Science Center, Houston
- Principal Investigator: Karen Ingersol, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCBDDD-3271
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Risk for an Alcohol-Exposed Pregnancy
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Baylor UniversityWayne State University; University of Texas at AustinRecruitingRisk for an Alcohol-Exposed Pregnancy | Risk for Marijuana-Exposed Pregnancy | Risk for Substance-Exposed Pregnancy | HIV Risk | Sexually Transmitted Infection RiskUnited States
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University of Colorado, DenverNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Exposed PregnancyUnited States
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Groupe Hospitalier Paris Saint JosephCompletedImmunocompromised Patients and Non-immunosuppressed Patients at Risk With an Indication for Pneumococcal VaccinationFrance
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University of VirginiaNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Minnesota and other collaboratorsNot yet recruitingSexual Behavior | Alcohol Use, Unspecified | Alcohol Exposed Pregnancy | Unplanned Pregnancy | Contraception UseUnited States
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Sebela Women's Health Inc.Synteract, Inc.Active, not recruitingWomen at Risk for PregnancyUnited States
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Sebela Women's Health Inc.Synteract, Inc.Active, not recruitingWomen at Risk for PregnancyUnited States
-
Sebela Women's Health Inc.PRA Health SciencesNot yet recruitingContraception | Women at Risk for PregnancyUnited States
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University of VirginiaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Exposed PregnancyUnited States
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The City College of New YorkNational Institute on Drug Abuse (NIDA)CompletedHIV PreventionSouth Africa
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Brown UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedBinge Drinking
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University of California, San DiegoUniversity of Southern California; Lundquist Institute for Biomedical Innovation... and other collaboratorsCompletedHIV Seronegativity | Patient AdherenceUnited States
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Rhode Island HospitalNational Institute on Drug Abuse (NIDA)CompletedHepatitis C | HIV | Drug UseUnited States
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Centers for Disease Control and PreventionUnknownAccidents, Traffic
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University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertension | Obesity | Diabetes | Metabolic Syndrome | Hypercholesterolemia
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University of CalgaryCompleted
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University of California, DavisSacramento Police Department; California Office of Traffic SafetyCompleted
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Boston UniversityU.S. Department of JusticeCompletedSexual Aggression | Offensive Aggression | Dating Violence Perpetration and VictimizationUnited States