Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact
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| First Received Date ICMJE | January 14, 2011 | ||||||||
| Last Updated Date | May 3, 2013 | ||||||||
| Start Date ICMJE | December 2009 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01280136 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact | ||||||||
| Official Title ICMJE | Web-Based Middle School HIV Prevention Curricula: Aspiring for Reach and Impact | ||||||||
| Brief Summary | The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district. This web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners. |
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| Detailed Description | The purpose of this study is to evaluate the effectiveness of a web-based HIV, sexually transmitted infection (STI), and pregnancy prevention curriculum as a stand alone intervention for 8th grade students in a large urban school district. Twenty middle schools were invited to participate in the study. From those schools, we randomized 10 to the intervention group and 10 to the comparison condition, and will then recruit a cohort of 2,000 8th grade students into the study. Parental permission and youth assent will be required prior to participation. Students will be asked to complete a baseline and 12-month follow-up survey. The web-based curriculum will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) but will be enhanced to include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior. The primary hypothesis to be tested is: (1) students who receive the web-based curriculum will delay sexual activity relative to those who receive standard care. The major dependent variable is the proportion of students initiating sexual activity (vaginal, oral, or anal sex). Secondary hypotheses will examine the effect of the web-based curriculum on specific types of sex (e.g., vaginal, oral, anal) and psychosocial variables such as students' intentions, knowledge, self-efficacy, attitudes, and perceived norms related to sexual risk-taking behavior. Secondary hypotheses will also examine the effect of the intervention on the proportion of students who are sexually active, number of times students engage in unprotected sexual intercourse, and students' number of sexual partners. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | 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 | Behavioral: It's Your Game Tech
An interactive web-based intervention for 8th grade students. This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
Other Name: IYG Tech |
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| Study Arm (s) | Experimental: It's Your Game Tech
An interactive web-based HIV, sexually transmitted infection (STI), and pregnancy prevention program for 8th grade students. This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
Intervention: Behavioral: It's Your Game Tech |
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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 | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 12 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 | NCT01280136 | ||||||||
| Other Study ID Numbers ICMJE | R01MH085594, R01MH085594 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Melissa Peskin, The University of Texas Health Science Center, Houston | ||||||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||||||
| Verification Date | May 2013 | ||||||||
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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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