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

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ClinicalTrials.gov Identifier: NCT00161382
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 24, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Tortolero, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE May 21, 2014
Results First Posted Date  ICMJE June 24, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE September 2002
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Proportion of students that are sexually active
  • Proportion initiating sexual intercourse
Change History Complete list of historical versions of study NCT00161382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Knowledge [ Time Frame: Measured throughout the study ]
  • Self-efficacy [ Time Frame: Measured throughout the study ]
  • Attitudes [ Time Frame: Measured throughout the study ]
  • Perceived Norms [ Time Frame: Measured throughout the study ]
  • Barriers [ Time Frame: Measured throughout the study ]
  • Communication With Parents [ Time Frame: Measured throughout the study ]
  • Proportion of Students That Are Sexually Active [ Time Frame: Measured over a period of 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Knowledge
  • Self-efficacy
  • Attitudes
  • Perceived Norms
  • Barriers
  • communication with parents.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
Official Title  ICMJE HIV Prevention Programs for Middle School Students
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Sexually Transmitted Diseases
  • Pregnancy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention Group
    HIV, STD, and pregnancy prevention curriculum
    Intervention: Behavioral: HIV, STD, and pregnancy prevention curriculum
  • Experimental: Control Group
    Standard sexual education curriculum
    Intervention: Behavioral: Standard sexual education curriculum
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
3007
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
1310
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161382
Other Study ID Numbers  ICMJE R01MH066640( U.S. NIH Grant/Contract )
R01MH066640-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Tortolero, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
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
PRS Account The University of Texas Health Science Center, Houston
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP