NCT00161382

Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students

HIV Prevention Programs for Middle School Students

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,007 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 11 Years – 16 Years
• Healthy volunteers: Accepted

Summary

This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

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: 1. Develop a model for obtaining community-based support for HIV, STD, and pregnancy prevention interventions for middle school students. 2. 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. 3. Develop an interactive CD-ROM-based tailored HIV, STD and pregnancy prevention intervention to provide individualized learning opportunities for middle school students. 4. 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. 5. 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. 6. Disseminate findings to the scientific community, school districts, and community agencies.

Conditions

• HIV Infections
• Sexually Transmitted Diseases
• Pregnancy

Interventions

Type	Name	Description
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.
BEHAVIORAL	Standard sexual education curriculum	Control curriculum consists of standard sexual education.

Timeline

• Start date: 2002-09-01
• Primary completion: 2007-03-01
• Completion: 2008-07-01
• First posted: 2005-09-12
• Last updated: 2014-07-08
• Results posted: 2014-06-24

Locations

1 site across 1 country: United States