Official Title: “HIV Prevention Programs for Middle School Students”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: March 2007

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.

Intervention(s) in this Clinical Trial

• Behavioral: HIV, STD, 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: Control Curriculum
  • Control curriculum consists of standard sexual education.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants receiving HIV, STD, and pregnancy prevention curriculum
• Active Comparator: 2
  • Participants receiving control curriculum

Primary Measures

• Proportion initiating sexual intercourse
  • Time Frame: Measured throughout the study
    Safety Issue?: No

Secondary Measures

• Knowledge
  • Time Frame: Measured throughout the study
    Safety Issue?: No
• Self-efficacy
  • Time Frame: Measured throughout the study
    Safety Issue?: No
• Attitudes
  • Time Frame: Measured throughout the study
    Safety Issue?: No
• Perceived norms
  • Time Frame: Measured throughout the study
    Safety Issue?: No
• Barriers
  • Time Frame: Measured throughout the study
    Safety Issue?: No
• Communication with parents
  • Time Frame: Measured throughout the study
    Safety Issue?: No
• Proportion of students that are sexually active
  • Time Frame: Measured over a period of 30 days
    Safety Issue?: No

Inclusion Criteria:

• 7th Grade
• Attend one of the ten recruited schools

Exclusion Criteria:

• Non-English speaking
• Physical disability that prevents student from completing intervention and survey

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 11 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Susan R. Tortolero, PhD Principal Investigator University of Texas Houston Health Science Center - School of Public Health  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00161382

Study ID Number: R01 MH66640

ClinicalTrials.gov Identifier: NCT00161382

Health Authority: United States: Federal Government