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Clinical Trials/NCT00161382
NCT00161382
Completed
N/A

HIV Prevention Programs for Middle School Students

The University of Texas Health Science Center, Houston1 site in 1 country3,007 target enrollmentSeptember 2002

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV Infections
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
3007
Locations
1
Primary Endpoint
Initiation of Sexual Intercourse
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
July 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Tortolero

◦Allan King Professorship in Public Health & Director, Center for Health Promotion and Prevention Research

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Self-efficacy(Measured throughout the study)
  • Knowledge(Measured throughout the study)
  • Attitudes(Measured throughout the study)
  • Perceived Norms(Measured throughout the study)

Study Sites (1)

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