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

Not Applicable

Completed

• Conditions: HIV Infections; Sexually Transmitted Diseases; Pregnancy
• Interventions: Behavioral: Standard sexual education curriculum; Behavioral: HIV, STD, and pregnancy prevention curriculum

• Registration Number: NCT00161382
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-03
• Study Completion: 2008-07
• Results First Submitted: 2014-05-21
• Results First Submitted QC: 2014-05-21
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Results First Posted: 2014-06-24
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3007

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard sexual education curriculum	Standard sexual education curriculum
Intervention Group	HIV, STD, and pregnancy prevention curriculum	HIV, STD, and pregnancy prevention curriculum

Primary Outcome Measures

Name	Time	Method
Initiation of Sexual Intercourse	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Houston Health Science Center - School of Public Health; 🇺🇸 Houston, Texas, United States