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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: |
NCT00218712 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men
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Scientific title:
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Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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488 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00218712 |
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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: Double Blind (Subject, Investigator), 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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Sandra Schwarcz, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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SFDPH-AIDS Office |
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Name:
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James W. Dilley, 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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UCSF AIDS Health Project |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV-infected
- Currently receiving HIV-specific primary medical care or mental health care
- Reports at least one episode of unprotected sex (receptive or insertive) with a male
partner who is either not infected or does not know if he is infected with HIV
(within 12 months prior to study enrollment)
- Plans to live in the San Francisco Bay Area for the next 12 months
Exclusion Criteria:
- History of intercourse on a regular basis with only one person
- Insufficient understanding of English
- Cognitive disorder that may affect ability to give informed consent
- Currently enrolled in any other behavioral or clinical HIV trials that could affect
participation in this study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Behavioral: Cognitive behavioral intervention
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Behavioral: Standard counseling
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Primary Outcome(s)
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Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention
[Time Frame: Measured at Months 6 and 12]
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Secondary ID(s)
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DAHBR 9A-ASPQ
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R01 MH073425
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R01MH073425
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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