Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
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|ClinicalTrials.gov Identifier: NCT00161382|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 24, 2014
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Sexually Transmitted Diseases Pregnancy||Behavioral: HIV, STD, and pregnancy prevention curriculum Behavioral: Standard sexual education curriculum||Not Applicable|
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:
- Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students.
- Adapt a tested, school-based, HIV, STD, and pregnancy prevention curriculum for middle school students using qualitative data from the target population, parents, and community representatives.
- Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students.
- Evaluate the effect of the multi-component intervention (classroom curriculum and CD-ROM intervention) on sexual behavior outcomes (proportion of students who initiate sexual intercourse, proportion of currently sexually active students having unprotected sexual intercourse, number of sexual partners, and intentions to have sexual intercourse) among middle school students.
- Evaluate the effect of the multi-component intervention on student impact variables such as knowledge, self-efficacy, attitudes, barriers, and perceived norms related to sexual risk-taking behavior and academic achievement among middle school students.
- Disseminate findings to the scientific community, school districts, and community agencies.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3007 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HIV Prevention Programs for Middle School Students|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||July 2008|
Experimental: Intervention Group
HIV, STD, and pregnancy prevention curriculum
Behavioral: HIV, STD, and pregnancy prevention curriculum
This HIV, STD, and pregnancy intervention program entitled, "It's Your Game...Keep it Real", consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits.
Experimental: Control Group
Standard sexual education curriculum
Behavioral: Standard sexual education curriculum
Control curriculum consists of standard sexual education.
- Initiation of Sexual Intercourse [ Time Frame: Measured throughout the study, and at 2006/2007 school year ]The effect of the intervention on delayed sexual initiation at the 9th-grade follow-up for those students who reported no lifetime sexual activity at baseline was assessed as the primary outcome. The primary hypothesis tested was that the intervention would decrease the number of adolescents who initiated sexual activity by the ninth grade relative to those in the comparison schools. Sexual activity was defined as participation in vaginal, oral, or anal sex. Sexual activity questions were defined in advance and were worded in a gender-neutral manner to illicit responses for same and opposite-sex partners.
- Knowledge [ Time Frame: Measured throughout the study ]
- Self-efficacy [ Time Frame: Measured throughout the study ]
- Attitudes [ Time Frame: Measured throughout the study ]
- Perceived Norms [ Time Frame: Measured throughout the study ]
- Barriers [ Time Frame: Measured throughout the study ]
- Communication With Parents [ Time Frame: Measured throughout the study ]
- Proportion of Students That Are Sexually Active [ Time Frame: Measured over a period of 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161382
|United States, Texas|
|University of Texas Houston Health Science Center - School of Public Health|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan R. Tortolero, PhD||University of Texas Houston Health Science Center - School of Public Health|
|Principal Investigator:||Christine M. Markham, PhD||University of Texas Houston Health Science Center - School of Public Health|