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| Tracking Information | |||||
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| First Received Date ICMJE | September 10, 2005 | ||||
| Last Updated Date | August 11, 2008 | ||||
| Start Date ICMJE | August 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
HIV risk behavior | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00182585 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computer-Assisted HIV Prevention for Young Drug Users | ||||
| Official Title ICMJE | Computer-Assisted HIV Prevention for Young Drug Users | ||||
| Brief Summary | In this study, the investigators are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. |
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| Detailed Description | Adolescents and young adults who use drugs are at high risk for infection with HIV, STDs and other diseases with similar transmission dynamics. Although several age-appropriate and effective HIV, STD and disease prevention efforts have been identified for young substance abusers, most interventions have been narrow in focus and are generally not structured to readily address changing patterns of drug use among adolescents that place them at risk for infection with these diseases. In this study, we are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. We plan to develop this program with the input from the target population of adolescents and young adults. We also plan to conduct a randomized, controlled trial to evaluate the benefit of including this program in HIV and disease prevention efforts with youth in substance abuse treatment. In so doing, we will evaluate the ability of the program to promote accurate knowledge about HIV and other diseases, promote self-efficacy to reduce risk behavior and change actual rates of risk behavior among young substance abusers. This computer-based program will be designed to promote the increased adoption of effective HIV and disease prevention science for this population. New information about changing patterns of drug use and HIV risk behaviors can be readily incorporated into the program as it becomes available. The program can be easily exported and able to be applied with fidelity. Importantly, the program will be structured such that a therapist or educator may customize the program content for use by various sub-populations of substance-abusing adolescents and young adults. Thus, the program will be able to address risk factors specific to each young drug user. This program may address many of the challenges associated with the current delivery of evidence-based HIV prevention programs to this population. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | HIV | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 56 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 13 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00182585 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 DA015964 | ||||
| Study Sponsor ICMJE | National Development and Research Institutes, Inc. | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Development and Research Institutes, Inc. | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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