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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT01125371 |
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Date of registration:
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17/05/2010 |
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Primary sponsor: |
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Public title:
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Computerized Brief Alcohol Intervention (BI) for Binge Drinking HIV At-Risk and Infected Women
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Scientific title:
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Computerized BI for Binge Drinking HIV At-Risk and Infected African-American Women |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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450 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01125371 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Luke Johnson, DO |
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Address:
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Telephone:
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410-396-4398 |
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Email:
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Affiliation:
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Name:
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Mary Yep, BA |
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Address:
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Telephone:
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410-935-7698 |
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Email:
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myep1@jhmi.edu |
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Affiliation:
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Name:
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Geetanjali Chander, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 18 years of age or older;
2. HIV infected or HIV negative and attending the Baltimore City Health Department
sexually transmitted infection clinic for STI-related services
3. Consumes an average of 8 or more drinks per week OR has had two binge drinking
episodes (4 drinks/occasion) in the last 3 months
4. sexually active
5. Cognitively able to understand proposed research design (10 min screening, followed
by random assignment to one of three study groups (if individual fulfills criteria
for RCT enrollment);
6. Able to speak and understand English
7. Able and willing to receive text messages
Exclusion Criteria:
1. Pregnant women will be excluded and referred directly to social work for referral to
either alcohol or drug treatment due to ethical concerns of randomization to usual
care.
2. Currently enrolled in alcohol or drug treatment.
3. Non-English Speaking.
4. Actively Psychotic or have other severe mental health symptoms that would prevent
appropriate participation in the brief intervention protocol.
5. Planning on moving out of the area within 12 months of study entry
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Binge Drinking
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Hazardous Alcohol Use
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High Risk Sexual Behaviors
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HIV Infection
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HIV Risk Reduction
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Intervention(s)
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Behavioral: Attention Control
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Behavioral: Computer delivered brief alcohol intervention
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Behavioral: Computerized brief alcohol intervention with IVR booster calls
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Primary Outcome(s)
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Reduction in alcohol use
[Time Frame: 0, 3, 6, and 12 months]
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Secondary Outcome(s)
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sexual risk behaviors
[Time Frame: 0, 3, 6, 12 months]
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Secondary ID(s)
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NIAAAGC018632
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R01AA018632
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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