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

Study Overview
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Brief Summary
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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
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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.

Official Title
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HIV Prevention Programs for Middle School Students

Conditions
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HIV Infections, Sexually Transmitted Diseases, Pregnancy

Intervention / Treatment
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* Behavioral: HIV, STD, and pregnancy prevention curriculum
* Behavioral: Standard sexual education curriculum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>HIV, STD, and pregnancy prevention curriculum | Behavioral: HIV, STD, and pregnancy prevention curriculum<br>* 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.<br>|
| Experimental: Control Group<br>Standard sexual education curriculum | Behavioral: Standard sexual education curriculum<br>* Control curriculum consists of standard sexual education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of Sexual Intercourse | 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. | Measured throughout the study, and at 2006/2007 school year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge |  | Measured throughout the study | 
| Self-efficacy |  | Measured throughout the study | 
| Attitudes |  | Measured throughout the study | 
| Perceived Norms |  | Measured throughout the study | 
| Barriers |  | Measured throughout the study | 
| Communication With Parents |  | Measured throughout the study | 
| Proportion of Students That Are Sexually Active |  | Measured over a period of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HIV Seronegativity