Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
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| First Received Date ICMJE | September 8, 2005 | ||||||||
| Last Updated Date | September 4, 2008 | ||||||||
| Start Date ICMJE | September 2002 | ||||||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion initiating sexual intercourse [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00161382 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 | Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students | ||||||||
| Official Title ICMJE | HIV Prevention Programs for Middle School Students | ||||||||
| Brief Summary | This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students. |
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| Detailed Description | The purpose of this study is to develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students using a randomized-controlled intervention trial. The intervention program consists of a classroom-based curriculum and an interactive CD-ROM. Ten middle schools were recruited to participate in this intervention trial. Five middle schools were randomized to the intervention group; and five middle schools were randomized to the control group. The study is also developing a model for obtaining community support for the development of HIV, STD and pregnancy prevention programs for middle school youth. The primary hypothesis to be tested is: Students attending middle schools who receive a multi-component HIV, STD, pregnancy prevention intervention will postpone sexual activity or reduce levels of current sexual activity relative to those in the comparison condition. The major dependent variables are proportion of students that are sexually active, and the proportion initiating sexual intercourse. Intentions to engage in sexual activity, number of times of unprotected sexual intercourse, and number of sexual partners will also be examined. Secondary hypotheses will examine the effect of the multi-component HIV, STD, and pregnancy prevention intervention on the student's knowledge, self-efficacy, attitudes, perceived norms, barriers, and communication with parents. The specific aims of this project are to:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 | ||||||||
| Enrollment ICMJE | 1307 | ||||||||
| Completion Date | July 2008 | ||||||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 11 Years to 16 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00161382 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH66640, DAHBR 9A-ASPA | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Susan Tortolero, University of Texas Health Science Center, Houston | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | The University of Texas Health Science Center, Houston | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | September 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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