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
Results First Received: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Self-efficacy   [ Time Frame: Measured throughout the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Attitudes   [ Time Frame: Measured throughout the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Perceived Norms   [ Time Frame: Measured throughout the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Barriers   [ Time Frame: Measured throughout the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Communication With Parents   [ Time Frame: Measured throughout the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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


  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
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  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: 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