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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susan Tortolero, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00161382
First received: September 8, 2005
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
HIV Infections
Sexually Transmitted Diseases
Pregnancy
Behavioral: HIV, STD, and pregnancy prevention curriculum
Behavioral: Standard sexual education curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention Programs for Middle School Students

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Initiation of Sexual Intercourse [ Time Frame: Measured throughout the study, and at 2006/2007 school year ] [ Designated as safety issue: No ]
    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:
  • Knowledge [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Attitudes [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Perceived Norms [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Barriers [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Communication With Parents [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
  • Proportion of Students That Are Sexually Active [ Time Frame: Measured over a period of 30 days ] [ Designated as safety issue: No ]

Enrollment: 3007
Study Start Date: September 2002
Study Completion Date: July 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161382

Locations
United States, Texas
University of Texas Houston Health Science Center - School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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
  More Information

Publications:
Responsible Party: Susan Tortolero, ◦Allan King Professorship in Public Health & Director, Center for Health Promotion and Prevention Research, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00161382     History of Changes
Other Study ID Numbers: R01 MH66640, R01MH066640-01
Study First Received: September 8, 2005
Results First Received: May 21, 2014
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center, Houston:
HIV Seronegativity
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 21, 2014