Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents (GET UP)
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ClinicalTrials.gov Identifier: NCT00831883 |
Recruitment Status
:
Completed
First Posted
: January 29, 2009
Last Update Posted
: December 5, 2012
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Sponsor:
Women and Infants Hospital of Rhode Island
Collaborator:
University of Rhode Island
Information provided by (Responsible Party):
Cynthia Rosengard, Women and Infants Hospital of Rhode Island
Tracking Information | ||||
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First Submitted Date ICMJE | January 28, 2009 | |||
First Posted Date ICMJE | January 29, 2009 | |||
Last Update Posted Date | December 5, 2012 | |||
Study Start Date ICMJE | February 2009 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
lower levels of sex-related HIV risk behavior [ Time Frame: 3 months ] | |||
Original Primary Outcome Measures ICMJE |
lower levels of sex-related HIV risk behavior [ Time Frame: 3 months & 6 months ] | |||
Change History | Complete list of historical versions of study NCT00831883 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents | |||
Official Title ICMJE | Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents | |||
Brief Summary | The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. | |||
Detailed Description | Incarcerated adolescents represent a group at high risk for health consequences associated with risky sexual behaviors. Condom use is more common with non-main than main sex partners and substance use in conjunction with sexual risk also appears to vary by partner type. The research team will conduct a small randomized trial to pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. Participants will be randomized to a 5 session HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model, or a 5 session healthy lifestyles psychoeducation intervention, and then reassessed 3 months after their access to the general community is reinstated. The main hypothesis is that participants in the HIV risk reduction intervention condition will have lower levels of sex-related HIV risk behavior and of substance use in conjunction with sexual risk, relative to those in a healthy lifestyles psychoeducation intervention. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
59 | |||
Original Estimated Enrollment ICMJE |
74 | |||
Actual Study Completion Date | January 2011 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 15 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00831883 | |||
Other Study ID Numbers ICMJE | 08-0128 R01DA022921-03 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Cynthia Rosengard, Women and Infants Hospital of Rhode Island | |||
Study Sponsor ICMJE | Women and Infants Hospital of Rhode Island | |||
Collaborators ICMJE | University of Rhode Island | |||
Investigators ICMJE |
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PRS Account | Women and Infants Hospital of Rhode Island | |||
Verification Date | December 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |