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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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17 October 2012 |
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Main ID: |
NCT00633906 |
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Date of registration:
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05/03/2008 |
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Primary sponsor: |
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Public title:
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HORIZONS HIV Intervention
HORIZONS |
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Scientific title:
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Reducing HIV Risk in Female Teens: A Tailored Approach |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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715 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00633906 |
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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: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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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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Ralph J DiClemente, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female
- African American
- Ages 15-21
- Receiving care at participating clinic
- Vaginal sex in the past 60 days
- Ability to give written informed consent
Exclusion Criteria:
- Married
- Pregnant
- In a detention center
Age minimum:
15 Years
Age maximum:
21 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Sexually Transmitted Diseases
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Intervention(s)
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Behavioral: enhanced standard-of-care
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Behavioral: HORIZONS HIV Intervention
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Primary Outcome(s)
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Proportion of condom protected vaginal sex acts over the last 60 days
[Time Frame: 6 and 12 months post-randomization]
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Secondary Outcome(s)
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Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
[Time Frame: 6 and 12 months post-randomization]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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