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

HIV Infections Clinical Trial

Official title:

HIV Prevention Programs for Middle School Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161382
• Other study ID #: R01MH066640
• Secondary ID: R01MH066640-01
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: June 23, 2014
• Start date: September 2002
• Est. completion date: July 2008

Study information

• Verified date: June 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will develop and evaluate a school-based HIV, STD, and pregnancy prevention program for 7th and 8th grade middle school students.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3007
• Est. completion date: July 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy
• Sexually Transmitted Diseases

Intervention

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.
• Standard sexual education curriculum
Control curriculum consists of standard sexual education.

Locations

Country	Name	City	State
United States	University of Texas Houston Health Science Center - School of Public Health	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Knowledge		Measured throughout the study	No
Secondary	Self-efficacy		Measured throughout the study	No
Secondary	Attitudes		Measured throughout the study	No
Secondary	Perceived Norms		Measured throughout the study	No
Secondary	Barriers		Measured throughout the study	No
Secondary	Communication With Parents		Measured throughout the study	No
Secondary	Proportion of Students That Are Sexually Active		Measured over a period of 30 days	No