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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00161382
First Posted: September 12, 2005
Last Update Posted: July 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan Tortolero, The University of Texas Health Science Center, Houston
Results First Submitted: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Diseases
Pregnancy
Interventions: Behavioral: HIV, STD, and pregnancy prevention curriculum
Behavioral: Standard sexual education curriculum

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 3,007 participants who were recruited for the study, 371 were excluded because of limited English proficiency and 1,191 were excluded because they did not obtain parental affirmative consent. Thus, 1,445 participants were randomized to either the comparison (n = 847) or the intervention (n = 598) condition.

Reporting Groups
  Description
Intervention Group

Participants receiving HIV, STD, and pregnancy prevention curriculum

HIV, STD, 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.

Control Group No intervention: Control curriculum consists of standard sexual education.

Participant Flow:   Overall Study
    Intervention Group   Control Group
STARTED   598 [1]   847 [2] 
COMPLETED   349 [3]   558 [4] 
NOT COMPLETED   249   289 
[1] Number of students allocated to intervention group
[2] Number of students allocated to comparison group
[3] Number of intervention students included in the analyzed cohort (i.e., completed 9th-grade survey)
[4] Number of control students included in the analyzed cohort (i.e., completed 9th-grade survey)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Group

Participants receiving HIV, STD, and pregnancy prevention curriculum

HIV, STD, 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.

Control Group No intervention: Control curriculum consists of standard sexual education.
Total Total of all reporting groups

Baseline Measures
   Intervention Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 349   558   907 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.1  (.57)   13.0  (.51)   13.0  (.54) 
Gender 
[Units: Participants]
     
Female   210   326   536 
Male   139   232   371 


  Outcome Measures

1.  Primary:   Initiation of Sexual Intercourse   [ Time Frame: Measured throughout the study, and at 2006/2007 school year ]

2.  Secondary:   Knowledge   [ Time Frame: Measured throughout the study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Self-efficacy   [ Time Frame: Measured throughout the study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Attitudes   [ Time Frame: Measured throughout the study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Perceived Norms   [ Time Frame: Measured throughout the study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Barriers   [ Time Frame: Measured throughout the study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Communication With Parents   [ Time Frame: Measured throughout the study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Proportion of Students That Are Sexually Active   [ Time Frame: Measured over a period of 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Susan R. Tortolero
Organization: The University of Texas Health Science Center at Houston (UTHealth) School of Public Health
phone: 713-500-9634
e-mail: Susan.Tortolero@uth.tmc.edu


Publications of Results:

Responsible Party: Susan Tortolero, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00161382     History of Changes
Other Study ID Numbers: R01MH066640 ( U.S. NIH Grant/Contract )
R01MH066640-01 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: May 21, 2014
Results First Posted: June 24, 2014
Last Update Posted: July 8, 2014