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

June 23, 2014 updated by: Susan Tortolero, The University of Texas Health Science Center, Houston

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3007

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Houston Health Science Center - School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured throughout the study, and at 2006/2007 school year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Susan R. Tortolero, PhD, University of Texas Houston Health Science Center - School of Public Health
  • Principal Investigator: Christine M. Markham, PhD, University of Texas Houston Health Science Center - School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH066640 (U.S. NIH Grant/Contract)
  • R01MH066640-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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