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

NCT ID: NCT00161382

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3007 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-07-31

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.

Conditions

HIV Infections; Sexually Transmitted Diseases; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

HIV, STD, and pregnancy prevention curriculum

Group Type: EXPERIMENTAL

HIV, STD, and pregnancy prevention curriculum

Intervention Type: BEHAVIORAL

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.

Control Group

Standard sexual education curriculum

Group Type: EXPERIMENTAL

Standard sexual education curriculum

Intervention Type: BEHAVIORAL

Control curriculum consists of standard sexual education.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard sexual education curriculum

Control curriculum consists of standard sexual education.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Susan Tortolero

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan R. Tortolero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Houston Health Science Center - School of Public Health

Christine M. Markham, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Houston Health Science Center - School of Public Health

Locations

University of Texas Houston Health Science Center - School of Public Health

Houston, Texas, United States

Countries

United States

References

Tortolero SR, Markham CM, Peskin MF, Shegog R, Addy RC, Escobar-Chaves SL, Baumler ER. It's Your Game: Keep It Real: delaying sexual behavior with an effective middle school program. J Adolesc Health. 2010 Feb;46(2):169-79. doi: 10.1016/j.jadohealth.2009.06.008. Epub 2009 Aug 18.

Reference Type: RESULT

PMID: 20113923 (View on PubMed)

Other Identifiers

R01MH066640-01

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH066640

Identifier Type: NIH

Identifier Source: org_study_id

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