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

NCT00161382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3007

Last updated 2014-07-08

Study results available
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Summary

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

Conditions

  • HIV Infections
  • Sexually Transmitted Diseases
  • Pregnancy

Interventions

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.

BEHAVIORAL

Standard sexual education curriculum

Control curriculum consists of standard sexual education.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Susan R. Tortolero, PhD · University of Texas Houston Health Science Center - School of Public Health

  • Christine M. Markham, PhD · University of Texas Houston Health Science Center - School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2007-03-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161382 on ClinicalTrials.gov